[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Malaysia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":686},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,380,0,25,[9,41,72,96,130,154,174,197,229,251,277,299,322,343,372,440,464,487,516,538,565,589,611,639,660],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100054056","phase-2-podomount-basket-a-study-to-test-whether-bi-764198-helps-adults-and-adolescents-with-different-types-of-kidney-disease-100054056",false,"NCT07355296","PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease","PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases","Inclusion Criteria:\n\n* Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent\u002Fassent (Visit 1)\n* Body Mass Index (BMI) of ≤40 kg\u002Fm2 at screening visit (Visit 1)\n* Weight of ≥40 kg at screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit\n\n  * For adult participants (≥18); ≥25 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit\n  * For adolescent participants (\\\u003C18); ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit\n* Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \\\u003C18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and \"true\" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \\\u003C18)\n* Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator\n* If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)\n* Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil\u002F-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period\n* Patients treated\u002Fto be treated with oral glucocorticoids have to be at a dose ≤10 mg\u002Fd prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* A history of organ transplantation or planned transplantation during the course of the study\n* Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)\n* Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial\n* Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit\n* Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>3X the upper limit of normal (ULN) at screening visit (Visit 1)\n* Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit\n* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.","ALL","12 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.\n\nParticipants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[27],"Proteinuric Kidney Diseases","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2026-03-23",{"date":36,"type":21},"2028-02-17",{"name":38,"class":39},"Boehringer Ingelheim","INDUSTRY",161,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100053313","phase-3-study-to-evaluate-the-efficacy-and-safety-of-abelacimab-in-high-risk-patients-with-atrial-fibrillation-who-have-been-deemed-unsuitable-for-oral-anticoagulation-lilac-timi-76-100053313","NCT05712200","Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","LILAC-TIMI 76","Inclusion Criteria:\n\n* Patient is able to understand and has provided written informed consent to participate in the trial\n* Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)\n* Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3\n* Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study\n* At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls\n* Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study\n\nExclusion Criteria:\n\n* AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)\n* Patients who within 60 days prior to randomization (1) received a vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (DOAC) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF\n* Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment\n* Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization\n* Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study\n* Patients on dialysis at screening or who are planned to start dialysis within 6 months\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply","65 Years",{"count":51,"type":21},2500,[53],"PHASE3","A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.",[56],"Atrial Fibrillation (AF)",[58,59,60,61,62,63],"abelacimab","randomized","placebo-controlled","double-blind","endpoint evaluation","atrial fibrillation",{"date":31,"type":32},{"date":66,"type":32},"2022-12-27",{"date":68,"type":21},"2027-12-30",{"name":70,"class":39},"Anthos Therapeutics, Inc.",789,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":79,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100054324","phase-3-a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-with-metastatic-prostate-cancer-mk-2400-001-100054324","NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE","18 Years",{"count":82,"type":21},1440,[53],"Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[86,87],"Prostate Cancer","Prostatic Neoplasms",{"date":31,"type":32},{"date":90,"type":32},"2025-05-13",{"date":92,"type":21},"2031-01-06",{"name":94,"class":39},"Merck Sharp & Dohme LLC",290,{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":129},"100053556","cognitive-care-bundle-for-ischaemic-stroke--a-pilot-randomised-controlled-trial-100053556","NCT07610291","Cognitive Care Bundle for Ischaemic Stroke : A Pilot Randomised Controlled Trial","Application of Cognitive Care Bundle to Ischaemic Stroke Patients and Its Effect on Post-Stroke Cognitive Outcome: A Pilot Randomised Controlled Trial","COGIS","Inclusion Criteria:\n\n1. Age 18 years old or older\n2. Diagnosis of ischemic stroke within 7 days\n3. Mild cognitive impairment noted during admission of stroke (MoCA 18-25)\n\nExclusion Criteria:\n\n1. GCS \\\u003C8\n2. Pre-stroke neurodegenerative disease (Parkinson's, Alzheimer's, Vascular Dementia, Frontotemporal Dementia, Mixed Dementia, Lewy Body Dementia)\n3. Patient with previous stroke\n4. Modified Rankin Scale of 4 and above\n5. Known psychiatric disorder\n6. Patient on psychotherapy medications (benzodiazepine, antidepressant, etc)\n7. Severe aphasia\n8. Logistical issues hindering follow up\n9. Delirium",{"count":105,"type":21},50,[107],"NA","The goal of this clinical trial is to learn if a set of treatments, called a \"cognitive care bundle,\" can help preserve cognitive ability in people who have had a stroke. This study will also test how feasible it is for people to follow this care bundle.\n\nThe main questions it aims to answer are:\n\n1. Do people find it feasible to follow the care bundle, which includes daily home blood pressure checks (and blood sugar checks for those with diabetes), along with referrals to specialists like dietitians, eye doctors, hearing specialists, and mental health professionals?\n2. Do people who receive the cognitive care bundle have better cognitive scores 3 months after their stroke, compared to those who receive standard care?\n\nResearchers will compare two groups of stroke survivors. One group will receive the cognitive care bundle plus standard medical care. The other group will receive standard medical care alone. This comparison will help researchers see if the care bundle works better to prevent cognitive decline.\n\nParticipants in the intervention (care bundle) group will:\n\nCheck and record their blood pressure daily at home (and their blood sugar too, if they have diabetes). Talk with a doctor weekly over the phone to review their readings and adjust medications if needed\n\nSee a dietitian for a personalized eating plan\n\nHave a hearing test by an audiologist\n\nHave a basic vision test by the research team\n\nAnswer a short questionnaire about their mood to screen for depression\n\nAll participants (in both groups) will undergo physiotherapy and cognitive training. Participants will be followed up with blood tests, examination by a doctor and questionnaires after 3 months.\n\nThis is a pilot study to see if this approach works and is practical to do in a larger future study.",[110,111],"Ischaemic Stroke","Cognitive Impairment, Mild",[113,114,115,116,117,118,119],"post-stroke cognitive impairment","care bundle","pilot","intervention","cognitive rehabilitation","blood pressure","hyperglycaemia","NOT_YET_RECRUITING",{"date":31,"type":32},{"date":123,"type":21},"2026-06",{"date":125,"type":21},"2029-04",{"name":127,"class":128},"National University of Malaysia","OTHER",1,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100054215","phase-3-a-study-in-adult-patients-with-paroxysmal-nocturnal-hemoglobinuria-pnh-to-evaluate-how-safe-long-term-treatment-with-pozelimab--cemdisiran-combination-therapy-is-and-how-well-it-works-100054215","NCT05744921","A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works","An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria","ACCESS-EXT","Key Inclusion Criteria:\n\nPatients Entering from the Parent Study\n\n1. Patients with PNH who have completed, without permanent discontinuation, study treatment in the parent study (R3918-PNH-2021\\[NCT05133531\\]), including the post-Open-label treatment period (OLTP) transition period, if applicable.\n2. Willing and able to comply with clinic visits and study-related procedures, including meningococcal vaccinations required per protocol.\n\nPatients Entering with C5 polymorphism\n\n1. Patients with PNH who have a documented C5 polymorphism rendering them refractory to eculizumab or ravulizumab (eg, p.Arg885His, p.Arg885Cys), as described in the protocol\n2. Diagnosis of PNH confirmed by high-sensitivity flow cytometry testing with PNH granulocytes or monocytes\n3. Active disease, as defined by the presence of 1 or more PNH-related sign or symptom as described in the protocol\n4. LDH level ≥2 × upper limit of normal (ULN) at the screening visit\n5. Willing and able to comply with clinic visits and study-related procedures, including meningococcal vaccinations required per protocol\n\nKey Exclusion Criteria:\n\nPatients Entering from the Parent Study\n\n1. Significant protocol deviation(s) in the parent study based on the investigator's judgment and to the extent that these would (if continued) impact the study objectives and\u002For safety of the patient\n2. Any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study\n\nPatients Entering with C5 polymorphism\n\n1. Prior treatment with complement inhibitors within 5 half-lives of the respective agent prior to screening, except for prior eculizumab or ravulizumab which are not exclusionary\n2. Receipt of an organ transplant, history of bone marrow transplantation or other hematologic transplant\n3. Not meeting meningococcal vaccination requirements and, at a minimum, documentation of quadrivalent meningococcal vaccination within 5 years prior to enrollment and serotype B vaccine within 3 years prior to enrollment as described in the protocol\n4. Positive hepatitis B surface antigen or hepatitis C virus Ribonucleic acid (RNA) during screening\n5. Patients with known HIV with history of opportunistic infections in the last 1 year as described in the protocol\n6. Known hereditary complement deficiency\n7. Documented history of active, uncontrolled, ongoing systemic autoimmune diseases\n8. Documented history of liver cirrhosis or patients with liver disease with evidence of current impaired liver function or patients with elevations in Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) (unrelated to PNH or its complications) as described in the protocol\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply",{"count":139,"type":21},202,[53],"This study is researching an experimental treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of this study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH in the long term. The pozelimab + cemdisiran combination may be referred to as \"study drugs\" in this section.\n\nThis study is looking at several other research questions, including:\n\n* How effective is the pozelimab + cemdisiran combination?\n* What side effects may happen from taking the study drugs?\n* How much of each study drug is in the blood at different times?\n* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)",[143],"Paroxysmal Nocturnal Hemoglobinuria",[145],"PNH",{"date":31,"type":32},{"date":148,"type":32},"2023-03-07",{"date":150,"type":21},"2029-02-26",{"name":152,"class":39},"Regeneron Pharmaceuticals",45,{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100053831","phase-2-a-study-of-mk-5684-in-people-with-certain-solid-tumors-mk-5684-015omaha-015-100053831","NCT06979596","A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015\u002FOMAHA-015)","A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Cohort A:\n\n  * Has a diagnosis of hormone receptor positive\u002FHuman Epidermal Growth Factor Receptor 2 negative (HR+\u002FHER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent.\n  * Has experienced disease progression on or after at least 1 prior endocrine-based therapy in the metastatic setting and received either, 1 line of an approved protocol-specified combination endocrine-based therapy, or 2 or more lines of protocol-specified endocrine-based therapy in the metastatic setting\n* Cohort B:\n\n  * Has histologically confirmed high-grade epithelial (including high-grade serous or predominantly serous, high-grade endometrioid, malignant mixed Müllerian tumors \\[carcinosarcoma\\], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinoma.\n  * Has received between 4 to 8 cycles of platinum-based doublet chemotherapy in third-line (3L) setting for ovarian cancer.\n* Cohort C:\n\n  * Histologically confirmed diagnosis of primary advanced or recurrent low-grade endometrioid carcinoma (eg, Federation of Gynecology and Obstetrics \\[FIGO\\] Grade 1\u002F2, or well\u002Fmoderately differentiated).\n  * Treatment naïve or has received up to 1 prior line of platinum-based therapy in either the advanced\u002Fmetastatic OR adjuvant\u002Fneoadjuvant setting.\n* All Cohorts :\n\n  * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.\n  * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.\n  * Participants who are Hepatitis B surface antigen positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load.\n  * Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Cohort A:\n\n  * Breast cancer amenable to treatment with curative intent.\n  * Has advanced\u002Fmetastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, radiographic evidence of intratumoral cavitation or invasion\u002Finfiltration of a major blood vessel, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control.\n* Cohort B:\n\n  * Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, low-grade serous, low-grade endometrioid, and undifferentiated carcinoma.\n  * Has platinum-resistant ovarian cancer (defined as disease that has progressed per radiographic imaging within 180 days after the last dose of first-line \\[1L\\] platinum-based therapy) or platinum-refractory ovarian cancer (defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of 1L platinum based therapy).\n  * Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer.\n* Cohort C:\n\n  * Has high-grade (FIGO Grade 3 or poorly differentiated) endometrioid carcinoma and nonendometrioid histologies of any type (including serous, clear cell, mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterine mesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas, and adenosarcomas are not eligible.\n  * Is a candidate for curative-intent surgery or curative-intent radiotherapy.\n* All Cohorts:\n\n  * Has confirmed or suspected adrenal metastases.\n  * Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications.\n  * Has any prior history or current condition of adrenal insufficiency.\n  * HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n  * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n  * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n  * Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n  * Has a history of stem cell\u002Fsolid organ transplant.\n  * Has not adequately recovered from major surgery or has ongoing surgical complications.",{"count":162,"type":21},250,[24],"Researchers want to learn if MK-5684 (the study medicine) can treat breast cancer, ovarian cancer, and endometrial cancer. MK-5684, the study medicine, is designed to treat cancer by blocking the body from making steroid hormones.\n\nResearchers will compare MK-5684 to the standard treatments for each cancer type in this study.\n\nThe goal of this study is to learn if people who receive MK-5684 live longer without the cancer growing or spreading compared to people who receive a standard treatment.",[166],"Malignant Neoplasm",{"date":31,"type":32},{"date":169,"type":32},"2025-08-11",{"date":171,"type":21},"2027-11-04",{"name":94,"class":39},57,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100053951","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dnth103-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-captivate-100053951","NCT06858579","A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","CAPTIVATE","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out.\n2. Weight range between 40 kilograms (kg) and 120 kg.\n3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.\n4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.\n5. Must be neurologically stable.\n6. Must have an INCAT score between 2 and 9 inclusive.\n7. Must fulfill one of the following treatment conditions for CIDP:\n\n   1. Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \\[IVIg\\] or subcutaneous immunoglobulin \\[SCIg\\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.\n   2. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.\n   3. Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and\u002For oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.\n   4. Treatment naïve with no history of prior treatment for CIDP.\n8. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.\n9. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.\n10. Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.\n\nExclusion Criteria:\n\n1. Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.\n2. Known evidence of central demyelination or known history of myelopathy.\n3. History or presence of significant medical\u002Fsurgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety\u002Fefficacy or study procedures.\n4. Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.\n5. Known complement deficiency or history of positive titer for anti-C1 antibodies.\n6. Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).\n7. Participants with an autoimmune disease affecting joints, muscle or nervous system.\n8. Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.\n9. Prior history of N. meningitidis infection.\n10. History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.\n11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.","75 Years",{"count":184,"type":21},256,[53],"The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).",[188],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":31,"type":32},{"date":191,"type":32},"2025-02-10",{"date":193,"type":21},"2030-12-31",{"name":195,"class":39},"Dianthus Therapeutics",180,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":212,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":228},"100053250","phase-3-neladalkib-nvl-655-for-tki-naive-patients-with-advanced-alk-positive-nsclc-100053250","NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization",{"count":206,"type":21},450,[53],"Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[210,211],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[213,214,215,216,217,218,219,220],"NSCLC","Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":31,"type":32},{"date":223,"type":32},"2025-07-17",{"date":225,"type":21},"2029-12",{"name":227,"class":39},"Nuvalent Inc.",156,{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},"100054283","phase-3-a-study-to-evaluate-zilovertamab-vedotin-mk-2140-combination-with-rituximab-plus-cyclophosphamide-doxorubicin-and-prednisone-r-chp-versus-rituximab-plus-cyclophosphamide-doxorubicin-vincristine-and-prednisone-r-chop-in-participants-with-previously-untreated-dlbcl-mk-2140-010-100054283","NCT06717347","A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n* Has received no prior treatment for their DLBCL\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization\n* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\n* Has a history of transformation of indolent disease to DLBCL\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n* Has Ann Arbor Stage I DLBCL\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n* Has clinically significant pericardial or pleural effusion\n* Has ongoing Grade \\>1 peripheral neuropathy\n* Has a demyelinating form of Charcot-Marie-Tooth disease\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has ongoing corticosteroid therapy\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) lymphoma\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant",{"count":237,"type":21},1046,[53],"The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.",[241],"Diffuse Large B-Cell Lymphoma",[243],"Lymphoma, Large B-Cell, Diffuse",{"date":31,"type":32},{"date":246,"type":32},"2025-01-27",{"date":248,"type":21},"2032-03-29",{"name":94,"class":39},266,{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":276},"100053849","phase-1-an-investigational-study-of-bgb-58067-as-a-single-agent-and-in-combination-with-anticancer-agents-in-participants-with-advanced-solid-tumors-100053849","NCT06589596","An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors","A Phase 1a\u002Fb Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination With Anticancer Agents in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must sign the ICF and be capable of giving written informed consent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70\n* Life expectancy ≥ 3 months\n* Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue\n* Able to provide tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing\n* Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose diseases have progressed or recurred after receiving standard systemic therapy or radiotherapy, or for whom standard systemic therapy is not available or tolerated, or would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard treatment in the opinion of the investigator; participants with advanced, metastatic, or unresectable solid tumors who have not received prior systemic treatment or have received one cycle of standard-of-care therapies will be enrolled in selected cohorts\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor\n* Active leptomeningeal disease or symptomatic spinal cord compression\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage\n* Any malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively\n* Significantly impaired pulmonary function\n* Clinically significant infections\n* Serologically active hepatitis B or C infection\n* Known HIV infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria\n* High cardiovascular risk factors\n* QTcF \\> 470 ms based on the screening triplicate 12-lead ECG records and\u002For a history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome)\n* Toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized\n* Participants who are unable to swallow or with disease\u002Fprocedure significantly affecting gastrointestinal function\n* Female participants who are pregnant or are breastfeeding\n* Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed)\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":259,"type":21},525,[261],"PHASE1","This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.",[264],"Advanced Solid Tumor",[266,267,268],"advanced solid tumor","BGB-58067","MTAP deficiency",{"date":31,"type":32},{"date":271,"type":32},"2025-01-10",{"date":273,"type":21},"2027-09-30",{"name":275,"class":39},"BeOne Medicines",96,{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":284,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":22,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100053921","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100053921","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of CD at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.","16 Years","80 Years",{"count":287,"type":21},1200,[53],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[291],"Crohn's Disease",{"date":31,"type":32},{"date":294,"type":32},"2024-06-05",{"date":296,"type":21},"2029-11-12",{"name":94,"class":39},499,{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":22,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":321},"100053407","phase-2-efficacy-safety-and-pharmacokinetics-of-vericiguat-in-pediatric-participants-with-heart-failure-due-to-left-ventricular-systolic-dysfunction-mk-1242-036-100053407","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days","17 Years",{"count":309,"type":21},342,[24,53],"This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[313,314],"Heart Failure","Left Ventricular Systolic Dysfunction",{"date":31,"type":32},{"date":317,"type":32},"2023-05-31",{"date":319,"type":21},"2032-04-15",{"name":94,"class":39},107,{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},"100053948","phase-3-a-study-of-intismeran-autogene-v940-plus-pembrolizumab-mk-3475-versus-placebo-plus-pembrolizumab-in-participants-with-non-small-cell-lung-cancer-v940-002-100053948","NCT06077760","A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)","A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)","INTerpath-002","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.\n* Has no evidence of disease before randomization.\n* Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.\n* No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Received prior neoadjuvant therapy for their current NSCLC diagnosis.\n* Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.\n* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Active infection requiring systemic therapy.",{"count":331,"type":21},868,[53],"The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \\[N2\\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.",[210],"2026-07-09",{"date":31,"type":32},{"date":338,"type":32},"2023-12-06",{"date":340,"type":21},"2035-12-21",{"name":94,"class":39},229,{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"100053363","phase-1-a-study-of-vrn110755-in-patients-with-egfr-mutant-non-small-cell-lung-cancer-100053363","NCT07699328","A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer","A Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)","REACH-EGFR","Inclusion Criteria:\n\n* Adults aged 18 years or older (19 years or older in the Republic of Korea).\n* Able to understand, sign, and provide written informed consent.\n* Histologically or cytologically confirmed advanced, metastatic, or recurrent predominantly nonsquamous non-small cell lung cancer (NSCLC) with a documented epidermal growth factor receptor (EGFR) mutation.\n* At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n* Documented EGFR mutation determined by tumor tissue or liquid biopsy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Able to swallow oral capsules and comply with study procedures.\n* Women of childbearing potential must have a negative pregnancy test, must not be breastfeeding, and must agree to use effective contraception during the study and for 7 months after the last safety follow-up visit. Men must agree to use effective contraception during the study and for 6 months after the last safety follow-up visit.\n* No appropriate standard treatment options are available or standard treatment is not considered feasible, in the opinion of the investigator.\n* Participants must meet the disease-specific eligibility criteria for one of the following study groups:\n\n  * Phase 1a\n\n    * NSCLC with EGFR activating, resistant, uncommon, or complex mutations, including but not limited to exon 19 deletion (Del19), L858R, C797S, or other uncommon EGFR mutations.\n    * Radiographic disease progression following at least 2 cycles of prior EGFR tyrosine kinase inhibitor (TKI) therapy or discontinuation of prior EGFR TKI therapy because of toxicity, with no remaining standard therapy expected to provide clinical benefit.\n  * Phase 1b - Cohort A\n\n    * NSCLC with EGFR exon 19 deletion or L858R mutation plus a C797X resistance mutation following disease progression after first-line treatment with a third-generation EGFR TKI (including osimertinib, lazertinib, or aumolertinib).\n  * Phase 1b - Cohort B\n\n    * Treatment-naïve NSCLC with common EGFR mutations.\n  * Phase 1b - Cohort C\n\n    * NSCLC with atypical or uncommon EGFR mutations (including G719X, L861Q, S768I, E709X, R776H, L747S, or combinations of these mutations) previously treated with at least one systemic therapy, including an EGFR TKI, with no remaining standard therapy expected to provide clinical benefit.\n  * Phase 1b - Cohort D\n\n    * Treatment-naïve NSCLC with atypical EGFR mutations.\n\nExclusion Criteria:\n\n* Received an investigational anticancer therapy within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment.\n* Unresolved side effects from previous anticancer therapy greater than Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), except for Grade 2 peripheral neuropathy or alopecia.\n* Pregnant or breastfeeding, or planning to become pregnant during the study.\n* NSCLC with an EGFR or HER2 exon 20 insertion mutation.\n* Another active malignancy within the past 3 years, with the exception of adequately treated cancers considered cured.\n* Inadequate bone marrow, kidney, or liver function based on protocol-defined laboratory criteria.\n* Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment.\n* Active hepatitis B or hepatitis C infection, or known human immunodeficiency virus (HIV) infection.\n* Receipt of a live vaccine within 4 weeks before the first dose of study treatment.\n* Use of strong or moderate cytochrome P450 (CYP) 3A inhibitors or inducers, certain herbal supplements, or other prohibited medications within the protocol-defined washout period.\n* Major surgery within 4 weeks before the first dose of study treatment or incomplete recovery from major surgery.\n* Receipt of prior anticancer therapy within the protocol-defined washout period, including systemic therapy, immunotherapy, or radiotherapy.\n* Symptomatic or uncontrolled central nervous system (CNS) metastases or spinal cord compression requiring increasing doses of corticosteroids. Participants with treated and stable CNS metastases or asymptomatic CNS disease may be eligible.\n* Requirement for systemic corticosteroid therapy exceeding the protocol-defined limit.\n* Clinically significant cardiovascular disease, including prolonged QT interval, clinically significant arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, uncontrolled hypertension, reduced left ventricular ejection fraction, or use of medications known to prolong the QT interval.\n* History of interstitial lung disease, noninfectious pneumonitis requiring steroid treatment, or current interstitial lung disease or pneumonitis.\n* Inability to swallow oral capsules or gastrointestinal disorders that may interfere with absorption of study treatment.\n* Known allergy or hypersensitivity to VRN110755 or any of its components.\n* Alcohol or drug abuse within the previous 2 years or any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with study participation or interpretation of study results.\n* Use of proton pump inhibitors, histamine-2 receptor antagonists, or locally acting antacids within the protocol-defined washout period or inability to comply with protocol requirements for acid-reducing medications.\n* For Phase 1b and Phase 2 only: Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including MET or HER2 amplification; ALK, ROS1, NTRK, or RET fusion; or BRAF V600E or KRAS G12X mutation.",{"count":352,"type":21},315,[261,24],"This first-in-human, Phase 1\u002F2, multicenter, open-label, non-randomized study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC).\n\nThe study includes a Phase 1a dose-escalation portion, a Phase 1b dose-expansion portion, and a Phase 2 evaluation. The study is designed to determine the maximum tolerated dose and recommended Phase 2 dose of VRN110755 and to evaluate preliminary and confirmatory antitumor activity in patients with EGFR-mutant NSCLC, including patients with acquired resistance following EGFR tyrosine kinase inhibitor therapy.",[356],"EGFR-Mutant Non-Small Cell Lung Cancer",[213,358,359,360,361,362,363],"EGFR","Epidermal Growth Factor Receptor","Non-Small Cell Lung Cancer","EGFR Mutation","C797S","EGFR Tyrosine Kinase Inhibitor Resistance",{"date":31,"type":32},{"date":366,"type":32},"2024-03-26",{"date":368,"type":21},"2029-01-01",{"name":370,"class":39},"Voronoi, Inc",29,{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":381,"briefSummary":382,"conditions":383,"keywords":390,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":439},"100607241","phase-3-study-to-evaluate-efficacy-and-safety-of-firmonertinib-compared-with-investigators-choice-of-egfr-inhibitor-as-first-line-treatment-in-participants-who-have-locally-advanced-or-metastatic-nsclc-with-egfr-p-loop-and-alpha-c-helix-compressing-pacc-uncommon-mutations-100607241","NCT07185997","Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations","A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)","Key Eligibility Criteria:\n\n* Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.\n* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.\n* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).\n* Patients who have received prior neo-adjuvant and\u002For adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.\n* Patients with asymptomatic CNS metastases are eligible.",{"count":380,"type":21},480,[53],"Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.",[384,385,386,387,388,389],"Non-Small-Cell Lung Cancer","Metastatic Non-Small-Cell Lung Cancer","Advanced Non-Small-Cell Lung Cancer","EGFR P-Loop and Alpha C-Helix Compressing","EGFR PACC","EGFR Uncommon Mutations",[391,392,393,394,395,396,397,398,399,213,400,401,402,403,404,405,406,407,408,215,358,409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429],"Non-Small Cell Lung Cancer (NSCLC)","PACC","Firmonertinib","Furmonertinib","AST2818","FURMO-006","Drug-Therapy","Metastatic Non-Small Cell Lung Cancer","Advanced Non-Small Cell Lung Cancer","Osimertinib","Afatinib","metastatic NSCLC first-line treatment","Carcinoma NSCLC","Respiratory tract neoplasms","Bronchial Neoplasms","Protein Kinase Inhibitors","tyrosine kinase inhibitor (TKI)","Alflutinib","EGFR kinase domain mutations","EGFR activating mutation","EGFR mutation of unknown significance","Non-classical EGFR mutation","EGFR uncommon mutations","EGFR atypical mutations","G719X","S768I","E709X","E709_T710delinsD","G779F","L747X","V774M","L747P\u002FS","R776C\u002FH","G724S","E736K","I740_K745dup","N771G","K757M\u002FR","V769L\u002FM","2026-07-01",{"date":432,"type":32},"2026-07-02",{"date":434,"type":32},"2025-12-17",{"date":436,"type":21},"2030-12",{"name":438,"class":39},"ArriVent BioPharma, Inc.",78,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":22,"phases":450,"briefSummary":451,"conditions":452,"keywords":454,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":463},"100599779","phase-2-a-study-to-evaluate-the-efficacy-safety-and-pk-of-azd0292-administered-iv-in-participants-12-years-of-age-and-older-with-bronchiectasis-and-chronic-pseudomonas-aeruginosa-colonization-100599779","NCT07088926","A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","CLEAR","Inclusion Criteria:\n\n1. Participant must be ≥ 12 years of age at the time of signing the informed consent\u002Fassent\n2. Weight ≥ 35 kg\n3. Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.\n4. Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics\n5. Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization\n6. Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.\n7. Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening\n8. Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.\n9. Capable of giving signed informed consent\u002Fassent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol\n\nExclusion Criteria:\n\n1. Primary lung diagnosis other than bronchiectasis\n2. Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy\n3. Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment\n4. Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed\n5. Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment\n6. AIDS or Advanced human immunodeficiency virus disease (CD4 count of \\\u003C 200 cells\u002Fmm3)\n7. History of severe adverse reaction associated with a mAb, and\u002For history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine\u002Fadrenaline or hospitalization), and\u002For history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration\n8. Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening\n9. Chronic immunosuppressive therapy (including prednisolone \\> 5 mg or equivalent) newly initiated within the last 3 months\n10. Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study\n11. Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening\n12. Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration",{"count":449,"type":21},435,[24],"AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.",[453],"Bronchiectasis With Pseudomonas Aeruginosa Colonization",[455],"Bronchiectasis Chronic Pseudomonas Aeruginosa Colonization",{"date":432,"type":32},{"date":458,"type":32},"2025-11-06",{"date":460,"type":21},"2028-06-14",{"name":462,"class":39},"AstraZeneca",185,{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":478,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":486},"100592970","phase-3-a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-patients-with-a-history-of-ascvd-events-or-at-high-risk-for-a-first-event-100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":473,"type":21},15100,[53],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[477],"Cardiovascular Disease",[479],"Atherosclerotic Cardiovascular Disease",{"date":432,"type":32},{"date":482,"type":32},"2025-06-04",{"date":484,"type":21},"2029-10-26",{"name":462,"class":39},1365,{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":495,"minAge":80,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":22,"phases":498,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":515},"100579031","phase-3-study-of-trastuzumab-deruxtecan-with-bevacizumab-versus-bevacizumab-monotherapy-for-first-line-maintenance-in-her2-expressing-ovarian-cancer-destiny-ovarian01-100579031","NCT06819007","Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)","A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01\u002FENGOT-ov89\u002FGEICO144- O\u002FGOG-3112\u002FAPGOT-OV13)","DO-01","Key Inclusion Criteria:\n\n1. Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures.\n\n   \\*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).\n4. Is newly diagnosed FIGO Stage III or IV.\n5. Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+\u002F2+\u002F1+) guidelines1 by prospective central testing.\n\n   \\*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \\[IHC 3+\u002F2+\u002F1+\\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.\n6. Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination.\n\n   \\*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.\n7. Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.\n8. Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion.\n\nKey Exclusion Criteria:\n\n1. Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.\n2. Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.\n3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows:\n\n   * HRD negative\n   * HRD positive with SD as best response after platinum\n   * HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea\n   * HRD tested, but inconclusive\n   * HRD positive but safety concern (safety concern to be specified).\n4. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.\n5. Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization.\n\n   \\*Note: For participants enrolled from the Republic of Korea,\n6. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).\n7. Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.\n8. Evidence of active or ongoing bowel obstruction.\n9. Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV).\n\n   Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n10. Has a corrected QT interval prolongation to \\>480 msec based on average of the Screening triplicate 12-lead ECG.\n11. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.","FEMALE",{"count":497,"type":21},582,[53],"This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \\[IHC\\] 3+\u002F2+\u002F1+) advanced high-grade epithelial ovarian cancer.",[501],"Ovarian Cancer",[503,504,505,506,507],"Ovarian cancer","epithelial ovarian cancer","HER2","Trastuzumab Deruxtecan","Bevacizumab",{"date":432,"type":32},{"date":510,"type":32},"2025-03-19",{"date":512,"type":21},"2032-01-31",{"name":514,"class":39},"Daiichi Sankyo",208,{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":537},"100517384","phase-3-a-long-term-study-of-elafibranor-in-adult-participants-with-primary-biliary-cholangitis-100517384","NCT06016842","A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis","A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)","ELFIDENCE","Inclusion Criteria :\n\n* Male or female participants must be ≥18 years of age at the time of signing the informed consent.\n* Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC)\n* Participants with cirrhosis at SV1. • Participants must be Child Pugh A or Child Pugh B.\n* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria :\n\n* History or presence of other concomitant liver disease including but not limited to:\n\n  * i) Primary sclerosing cholangitis (PSC).\n  * ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) ≥6, or if treated for an overlap of PBC with AIH, or if there is clinical suspicion and evidence of overlap AIH features, that cannot be explained alone by insufficient response to UDCA.\n  * iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if hepatitis B virus deoxyribonucleic acid (HBV DNA) is negative.\n  * iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive anti-HCV antibody due to previously treated HCV infection, may be enrolled if a confirmatory HCV RNA is undetectable and sustained viral response has been documented).\n  * v) Alcohol-associated liver disease (ALD).\n  * vi) Nonalcoholic steatohepatitis (NASH).\n  * vii) Other chronic liver diseases, such as alpha-1 antitrypsin deficiency.\n* History or presence of clinically significant hepatic decompensation, including:\n\n  * i) History of liver transplantation, current placement on a liver transplant list, current model for end-stage liver disease including (MELD) 3.0 score \\>12 due to hepatic impairment.\n  * ii) Evidence of complications of cirrhosis, including hepatic decompensation or evidence of significant portal hypertension complications including presence of uncontrolled ascites; history of variceal bleeding or related interventions (e.g. variceal banding, or transjugular intrahepatic portosystemic shunt placement); presence of hepatic encephalopathy Grade 2 or higher per West-Haven criteria; history or presence of spontaneous bacterial peritonitis. Note: participants with low-risk varices (Grade I) without history of bleeding or other treatment may be eligible to enrol.\n  * iii) Hepatorenal syndrome (HRS) (type I or II ). • vi) Hospitalisation for liver-related complication within 12 weeks prior to SV1.\n* Known history of human immunodeficiency virus (HIV) infection or having a positive confirmatory test for HIV type 1 or 2.\n* Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).\n* Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator; other clinically significant conditions that are not well controlled.\n* Non-hepatic medical conditions that may diminish life expectancy to \\\u003C2 years, including known cancers.\n* History of hepatocellular carcinoma.\n* Alpha-fetoprotein (AFP) \\>20 ng\u002FmL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) imaging suggesting presence of hepatocellular carcinoma.\n* Known malignancy or history of malignancy within the last 5 years. Participants with non-melanoma skin cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: • i) 3 months prior to baseline: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid or nitrofurantoin).\n* Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer, prior to the screening period.\n\n  i) If the previous study was for an experimental therapy being studied for potential benefit in PBC, and the potential therapeutic agent was proven to have no beneficial effect in PBC and there are no safety concerns, the participant may enrol after 30 days or 5 half-lives from the last dose of the therapeutic agent, whichever is longer.ii) For therapeutic agents being studied for potential benefit in PBC for which it is still unclear if there may be a potential benefit, participants may enrol after 6 months from the last dose of the therapeutic agent.\n* Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \\>450 msec in males or QTcF \\>470 msec in females for participants without bundle branch block. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF \\>480 msec would be exclusionary.\n* Total bilirubin (TB) \\>5x ULN\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>5x ULN at SV1\n* Creatinine phosphokinase (CPK) \\>2x ULN.\n* Platelet count \\\u003C50,000\u002FμL\n* International normalised ratio (INR) \\>1.8 in the absence of anticoagulant therapy.\n* Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m2 per the Modification of Diet in Renal Disease (MDRD)-6 Study formula at SV1.\n* Significant renal disease, including nephritic syndrome, chronic kidney disease (CKD) (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).\n* For female participants: known current pregnancy, or has a positive serum pregnancy test, or is breastfeeding.\n* Participants unwilling or unable to be abstinent from alcohol during the study.\n* History of alcohol abuse, or other substance abuse within 1 year prior to SV1.\n* Known hypersensitivity to elafibranor or to any of the excipients of the investigational product(s).\n* Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.\n* Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.\n* Alkaline phosphatase (ALP) ≥10x ULN.\n* Albumin \\\u003C2.8 g\u002FdL due to impaired hepatic function.",{"count":525,"type":21},276,[53],"The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver).\n\nPBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage.\n\nThe liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.\n\nThis study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant.\n\nThe main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death).\n\nThis study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.",[529],"Primary Biliary Cholangitis (PBC)",{"date":432,"type":32},{"date":532,"type":32},"2023-08-31",{"date":534,"type":21},"2029-05-31",{"name":536,"class":39},"Ipsen",186,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":22,"phases":547,"briefSummary":548,"conditions":549,"keywords":553,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":564},"100590383","phase-3-a-clinical-study-of-sacituzumab-tirumotecan-sac-tmt-mk-2870-in-people-with-breast-cancer-mk-2870-032-100590383","NCT06966700","A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)","A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin\u002FPaclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive\u002FHuman Epidermal Growth Factor Receptor-2 Negative Breast Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and\u002For clinical assessment:\n\n  * cT1c, N1-N2\n  * cT2, N0-N2\n  * cT3, N0-N2\n  * cT4a-d, N0-N2\n* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+\u002FHER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement\n* Has received any prior treatment, including radiation, systemic therapy,and\u002For definitive surgery for currently diagnosed breast cancer\n* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and\u002For axillary sentinel lymph node biopsy prior to study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).\n* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Uncontrolled systemic disease.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids, has current pneumonitis\u002Finterstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..",{"count":546,"type":21},2400,[53],"Researchers are looking for new ways to treat types of breast cancer that are both:\n\n* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment\n* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive\u002Fhuman epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.\n\nSacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.\n\nThe main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:\n\n* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy\n* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy",[550,551,552],"Breast Neoplasms","Triple Negative Breast Neoplasms","HR Low-Positive\u002FHER2-Negative Breast Neoplasms",[554,555,556],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","2026-06-30",{"date":432,"type":32},{"date":560,"type":32},"2025-06-30",{"date":562,"type":21},"2034-12-29",{"name":94,"class":39},310,{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":22,"phases":575,"briefSummary":576,"conditions":577,"keywords":579,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":588},"100587974","phase-3-a-study-to-learn-about-the-effects-of-felzartamab-infusions-on-adults-with-immunoglobulin-a-nephropathy-igan-100587974","NCT06935357","A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)","PREVAIL","Key Inclusion Criteria:\n\n* Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, an IgAN diagnostic biopsy within the past 24 months prior to signing the ICF.\n* An eGFR ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and \\\u003C 30 mL\u002Fmin\u002F1.73 m\\^2 is acceptable for the cohorts 3 and 4.\n* Proteinuria of ≥ 1.0 gram per day (g\u002Fday) or UPCR ≥0.8 gram per gram (g\u002Fg) as assessed by an adequate 24-hour urine collection.\n* Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is); endothelin receptor antagonists (ERAs) or dual endothelin angiotensin receptor antagonist (DEARAs) approved for the treatment of IgAN; and\u002For mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using a DEARA (e.g., sparsentan) will not be permitted to use simultaneous ACEI or ARB medication.\n\nKey Exclusion Criteria:\n\n* Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator.\n* History of rapidly progressive variant of IgAN, defined as eGFR loss by \\> 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors.\n* IgAN-(MCD) variant.\n* Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.\n* Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) \\> 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy).\n* Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants.\n* Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic glucocorticoid exposure (\\> 7.5 milligrams per day \\[mg\u002Fd\\] prednisone-equivalent for indications other than IgAN or any dose if given for the treatment of IgAN) within 4 months prior to Screening. Use of hydroxychloroquine in Mainland China is allowed if the candidate has been on this for at least 6 months prior to Screening with a stable dose for at least 12 weeks prior to Screening. If a potential participant requires systemic glucocorticoids at any dose for IgAN during Screening, this will result in a screen fail. If a potential participant requires systemic glucocorticoids \\> 7.5 mg\u002Fday prednisone-equivalent for indications other than IgAN during Screening, this will result in a screen fail.\n* Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to Screening may be eligible.\n* Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or non-prophylactic treatment with IV anti-infectives (antibacterials, antiviral or antifungals). Participants with a history of opportunistic infections are excluded.\n* Hypogammaglobulinemia: serum Immunoglobin G (IgG) \\\u003C 6.0 gram per litre (g\u002FL), at Screening.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":574,"type":21},454,[53],"In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys.\n\nThe main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is:\n\n• How much does the amount of protein in the urine change from the start of the study to Week 36?\n\nResearchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body.\n\nThe study will be done as follows:\n\n* Participants will be screened to check if they can join the study.\n* Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.\n* Neither the researchers nor the participants will know what the participants will receive.\n* Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks.\n* Afterwards, participants will enter a follow-up period which will last 80 weeks.\n* In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.",[578],"Immunoglobulin A Nephropathy (IgAN)",[580],"Felzartamab",{"date":430,"type":32},{"date":583,"type":32},"2025-05-08",{"date":585,"type":21},"2029-06-05",{"name":587,"class":39},"Biogen",246,{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":22,"phases":599,"briefSummary":600,"conditions":601,"keywords":602,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":610},"100585189","phase-3-study-of-trastuzumab-deruxtecan-pembrolizumab-and-platinum-based-chemotherapy-in-first-line-her2-overexpressing-non-small-cell-lung-cancer-100585189","NCT06899126","Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer","A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS \u003C50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)","DESTINY-Lung06","Inclusion Criteria:\n\n1. Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures.\n\n   Sign and date the Optional PGx ICF (included in the Main ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Histologically documented non-squamous locally advanced unresectable or metastatic\n\n   NSCLC and meets all of the following criteria:\n\n   Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on the local test results obtained using validated or approved tests as required per local regulation) that have locally available therapies targeting their AGAs in the first-line advanced\u002Fmetastatic setting.\n\n   Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if non-squamous NSCLC is the predominant histology. Mixed tumors will be classified based on the predominant cell type.\n4. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1\u002FPD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant\u002Fneoadjuvant therapy was given at least 6 months before the date of the first trial dose if their disease has progressed at least 6 months after the last dose date of adjuvant\u002Fneoadjuvant therapy.\n\n   1. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I.\n   2. HER2-targeted antibody-based anticancer therapy.\n5. Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor-specified laboratory. A new biopsy is required if the participant's most recent archival tumor tissue sample cannot be supplied.\n\nDetails pertaining to tumor tissue submission can be found in the Trial Laboratory Manual.\n\nExclusion Criteria:\n\n1. Has a medical history of MI within 6 months before randomization\u002Fenrollment or symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms must be ruled out for MI. It is highly recommended that the investigator refer such participants for a cardiologic consultation during the Screening Period.\n2. Has a QTc prolongation to \\>480 ms based on the average of the Screening triplicate 12- lead ECG.\n3. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n4. Has clinically severe pulmonary compromise resulting from intercurrent, pulmonary illnesses including, but not limited to:\n\n   1. Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion).\n   2. Any auto immune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis).\n\n   Severe conditions are those defined as impacting daily activities and\u002For requiring use of supplemental oxygen.\n5. Had a prior complete pneumonectomy.",{"count":598,"type":21},686,[53],"This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \\\u003C50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced\u002Fmetastatic setting.",[210],[603,213],"DESTINY",{"date":432,"type":32},{"date":606,"type":32},"2025-10-24",{"date":608,"type":21},"2032-11-24",{"name":514,"class":39},160,{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":626,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":638},"100367421","phase-3-a-study-to-evaluate-long-term-safety-in-participants-who-have-participated-in-other-luspatercept-ace-536-clinical-trials-100367421","NCT04064060","A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","A Phase 3b, Open-label, Single-arm, Rollover Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be enrolled in this study:\n\n1. Participant is ≥ 18 years at the time of signing the informed consent form (ICF).\n2. Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n3. Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the participant has been either:\n\n   1. Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive luspatercept treatment, OR\n   2. Assigned to placebo arm in the parent protocol (at the time of unblinding or in follow-up) and should cross over to luspatercept treatment, OR\n   3. Assigned to the Follow-up Phase of the parent protocol, previously treated with luspatercept or placebo in the parent protocol who shall continue into LTPTFU phase in the rollover study until the follow-up commitments are met (unless requirements are met as per parent protocol to crossover to luspatercept treatment).\n4. Participant understands and voluntarily signs an informed consent document prior to any study-related assessments or procedures being conducted.\n5. Participant demonstrates compliance, as assessed by the investigator, with the parent study protocol requirements.\n6. Applies to on treatment Participants only- females of childbearing potential (FCBP) defined as a sexually mature woman who:\n\n1\\) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must:\n\n1. Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the participant practices true abstinence from heterosexual contact.\n2. Agrees to use, and be able to comply with highly effective, contraception without interruption, 35 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 84 days after discontinuation of study therapy.\n\n   7\\. Applies to on treatment participants only- Male participants must:\n\na. Agrees to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 84 days following investigational product discontinuation even if he has undergone a successful vasectomy.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a participant from enrollment:\n\n1. Applies to on treatment participants only- Concomitant use of any medications\u002Fprocedures that are prohibited in the parent luspatercept protocol.\n2. Participant has met one or more criteria for study discontinuation as stipulated in the parent luspatercept protocol.\n3. Applies to on treatment participants only- More than 26 days between last luspatercept dose in the parent protocol and first dose into ACE-536-LTFU-001 protocol unless dose delay or dose discontinuation criteria met.\n4. Applies to on treatment participants only- Pregnant or breastfeeding females.\n5. Participant has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg, imprisoned or institutionalized) that would prevent the subject from participating in the study.\n6. Participant has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study.\n7. Participant has any condition that confounds the ability to interpret data from the study.",{"count":619,"type":21},665,[53],"A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants:\n\n* Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept\n* Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met\n* The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase\n* Transition Phase is defined as one Enrollment visit\n* Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol\n* Follow-up Phase includes:\n\n  \\- 42 Day Safety Follow-up Visit\n* During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting\n\n  \\- Long-term Post-treatment Follow-up (LTPTFU) Phase\n* Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies\u002Fpre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule\n\nParticipants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study.\n\nThe ACE-536-LTFU-001 rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill 5 years on the study, including treatment and follow-up.",[623,624,625],"Myelodysplastic Syndromes (MDS)","Beta-thalassemia","Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis",[627,628,629,624,630],"ACE-536","Luspatercept","MDS","Myeloproliferative neoplasm (MPN)-associated myelofibrosis",{"date":430,"type":32},{"date":633,"type":32},"2019-08-12",{"date":635,"type":21},"2028-05-12",{"name":637,"class":39},"Celgene",143,{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":649,"phases":4,"briefSummary":650,"conditions":651,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":129},"100626187","intrapleural-alteplase-tyloxapol-vs-intrapleural-alteplase-dnase-in-pleural-infection-100626187","NCT07432373","Intrapleural Alteplase-Tyloxapol vs Intrapleural Alteplase-DNase in Pleural Infection","Comparative Analysis of Intrapleural Alteplase-Tyloxapol vs Intrapleural Alteplase-DNase in Pleural Infection (ALTON-PI)","ALTON-PI","Inclusion Criteria:\n\nInclusion Criteria\n\n1. Adult patient aged ≥ 18 years old\n2. Patients with pleural infection (complex parapneumonic effusion or empyema) with poor pleural fluid drainage of ≤ 150 ml after 24 hours of chest drain insertion received either t-PA-DNAse or t-PA\u002FTyloxapol.\n3. Clinical features consistent with pleural infection; fulfilling ≥ 2 of the following characteristics:\n\n   i) Clinical evidence of infection, such as fever and or elevated C-reactive protein (CRP) or total white blood count (TWBC) ii) Complex pleural effusion proven by thoracic ultrasound is defined as the presence of fibrin strands or septations within the pleural cavity iii) Pleural fluid that fulfils at least one of the characteristics:\n   * Frank Pus,\n   * Exudative type of pleural effusion (according to light's criteria)\n   * Gram stain or culture positive\n   * Lactate dehydrogenase (LDH) \\> 900U\u002FL\n   * Acidic with pH \\\u003C 7.2\n   * Glucose level \\\u003C 3.3 mmol\u002FL\n\nExclusion Criteria:\n\n1. Incomplete data.\n2. Medical records that cannot be retrieved.",{"count":648,"type":21},80,"OBSERVATIONAL","Pneumonia, thought to be the chief aetiological process in the development of pleural space infection, is defined as an infection of the lung parenchyma with an estimated annual incidence rate of 5-11 cases per 1000 population, with around 50,000 hospital admissions in the U.K. per year. Parapneumonic effusions caused by an infection of the pleural membranes occur in 40-57% of cases of pneumonia. A variable percentage (10-20%) of parapneumonic effusions progresses to empyema (pus) and\u002For abscess formation (encapsulation). Pleural infection is associated with significant morbidity and mortality, which may be as high as 20-35% in immunocompromised patients.\n\nStandard treatment of these collections in adults involves antibiotic therapy, adequate drainage of infected fluid, and surgical intervention if conservative management fails. Appropriate treatment is adequate drainage via an intercostal catheter (ICC) with antibiotic therapy for parapneumonic effusions requiring clearance. Frequently, simple ICC drainage is ineffective due to the presence of loculations, formed predominantly by fibrinous material deposited in the fibrinopurulent phase of empyema, preventing free drainage of infected pleural fluid. The presence of fibrinous septae in the pleural space, known as loculations, may result in inadequate drainage of effusions and, therefore, nonresolution of infection and systemic sepsis. Surgical intervention (VATS or open) is usually required to clear loculations and resolve infection without adequate intercostal catheter drainage.\n\nAlthough the success rate of surgical intervention remains high, the morbidity and mortality of both VATS and open thoracotomy are of concern, particularly in a cohort of patients who may be older and with significant comorbidity. Less invasive therapies, which promote pleural space drainage and effective resolution of pleural infection, are therefore likely to be of considerable clinical utility.\n\nThe MIST 2 trial has established intrapleural therapy as the mainstay of CPEE treatment, hence avoiding surgery and decreasing the length of hospitalization; however, little is known about the correct dosage needed for tPA and Dornase Alfa\u002FDeoxyribonuclease (DNase). Dose and duration of intrapleural therapy based on MIST 2 involve multiple dosing and can be time-consuming for health care providers. Nevertheless, treatment of pleural infection with fibrinolytic therapy has been incorporated in the British Thoracic Society guideline 2023.\n\nAnother study in 2022 by Cheong et al. used a modified regimen of intrapleural alteplase 16 mg t-PA with 5 mg DNase for three doses administered sequentially within 24 h. In this study, a modified regimen of t-PA and DNase offers an alternative therapeutic option for patients who are unfit or refuse surgical intervention but have persistent pleural infection. They have demonstrated similar treatment success comparable to other studies, as evidenced by improved pleural fluid drainage and reduced pleural opacity on day 7 chest x-ray, approximately 50% from the baseline. The mechanism of action of t-PA and DNase in the pleural cavity remains unclear. Studies suggested that IPFT may trigger the monocyte chemoattractant protein 1 (MCP-1) pathway, which promotes pleural fluid formation and subsequently causes a therapeutic lavage effect that increases pleural fluid drainage.",[652],"Pleural Infection","2026-06-29",{"date":557,"type":32},{"date":656,"type":32},"2026-04-01",{"date":658,"type":21},"2028-07-01",{"name":127,"class":128},{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":666,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":22,"phases":670,"briefSummary":671,"conditions":672,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":678,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":685},"100601857","streamlined-denervation-with-spyral-for-an-optimized-treatment-spyral-swyft-in-subjects-with-uncontrolled-hypertension-100601857","NCT07115953","Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension","Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)","SWYFT","Inclusion Criteria:\n\n1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg\n2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg\n3. Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre-procedure measurements)\n4. Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline\n\nExclusion Criteria:\n\n1. Individual lacks appropriate renal artery anatomy\n2. Individual has undergone prior renal denervation\n3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement\n4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea\n5. Individual has an estimated glomerular filtration rate (eGFR) of \\\u003C45 mL\u002Fmin\u002F1.73m2\n6. Individual has one or more episode(s) of orthostatic hypotension\n7. Individual is pregnant, nursing or planning to become pregnant\n8. Individual has documented primary pulmonary hypertension\n9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%",{"count":669,"type":21},130,[107],"The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.",[673,674,675,676,677],"Hypertension","Vascular Diseases","Cardiovascular Diseases","Chronic Kidney Diseases","Diabetes Mellitus",{"date":557,"type":32},{"date":680,"type":32},"2025-09-22",{"date":682,"type":21},"2029-12-31",{"name":684,"class":39},"Medtronic Vascular",21,""]