[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Denmark\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":662},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1634,0,25,[9,41,64,87,110,132,158,186,207,234,260,303,334,356,381,403,435,459,480,503,533,553,575,608,638],{"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":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100054317","phase-3-dareon-nec-1-a-study-in-people-with-advanced-extrapulmonary-neuroendocrine-cancer-epnec-to-compare-obrixtamig-plus-carboplatin-and-etoposide-treatment-with-standard-chemotherapy-100054317","NCT07544654","DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy","A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas","Inclusion Criteria:\n\n1. Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 \\>20% or mitotic rate mitotic rate with number of mitoses \\>20 per 2 mm2, regardless of primary site (including site of unknown origin)\n2. Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue\n3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease\n4. Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg\u002Fm2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg\u002Fm2) prior to randomisation\n5. Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)\n6. Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay\n7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n8. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma\n3. Patients with neuroendocrine prostate cancer\n4. Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition\n5. Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)\n6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n7. Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)\n8. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and\u002For CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible Further exclusion criteria apply.","18 Years",{"count":50,"type":21},390,[52],"PHASE3","This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3).\n\nParticipants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein.\n\nDuring the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.",[55],"Extrapulmonary Neuroendocrine Cancer (epNEC)","NOT_YET_RECRUITING",{"date":31,"type":32},{"date":59,"type":21},"2026-07-07",{"date":61,"type":21},"2031-03-11",{"name":38,"class":39},165,{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100054199","a-study-of-varipulse-catheter-and-trupulse-generator-with-varipulse-pro-software-in-participants-with-paf-or-psaf-100054199","NCT07429214","A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF","Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software","VP-CONFIRM","Inclusion criteria:\n\n* Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)\n* Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation\n* Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD\n* Age 18-75 years\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post- and follow-up testing and requirements\n\nExclusion criteria:\n\n* Continuous AF greater than (\\>) 12 months (1-Year) (Longstanding Persistent AF)\n* Previous surgical or catheter ablation for atrial fibrillation\n* Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention \\[PCI\\])\n* Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure\n* Any carotid stenting or endarterectomy\n* Presence of left atrium (LA) thrombus\n* Severe dilatation of the LA (left atrial diameter \\[LAD\\] \\>50 millimeters \\[mm\\] antero-posterior diameter in case of transthoracic echocardiography \\[TTE\\])\n* Severely compromised left ventricular ejection fraction (LVEF less than \\[\\\u003C\\] 40 percent \\[%\\])\n* Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study\n* Prior diagnosis of pulmonary vein stenosis\n* Pre-existing hemi diaphragmatic paralysis\n* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)\n* Myocardial infarction (MI) within the past 2 months (60 days prior to consent date)\n* Documented thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 6 months \\[180 days prior to consent date\\])\n* Rheumatic Heart Disease\n* Uncontrolled heart failure or New York heart association (NYHA) function class III or IV\n* Severe mitral regurgitation\n* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months\n* Unstable angina pectoris within the past 6 months prior to consent date\n* Acute illness or active systemic infection or sepsis\n* Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity \\[Body Mass Index \\>40 kilogram per meter square {kg\u002Fm\\^2}\\], renal insufficiency (with an estimated creatinine clearance \\\u003C 30 milliliters per minute {mL\u002Fmin}\u002F1.73 m\\^2)\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation\n* Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter\n* Presence of any other condition that precludes appropriate vascular access (such as inferior vena cava \\[IVC\\] filter)\n* Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease \\[COPD\\]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms\n* Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation\n* Current enrollment in an investigational study evaluating another device, biologic, or drug\n* Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)\n* Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being\n* Life expectancy less than 12 months\n* Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia, implantable pacemakers, implantable cardioverter\u002Fdefibrillators (ICDs),etc. (at principal investigator \\[PI\\] discretion)\n* Presence of iron-containing metal fragments in the body\n* Unresolved pre-existing neurological deficit","75 Years",{"count":74,"type":21},50,[76],"NA","The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with the new VARIPULSE™ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).",[79],"Atrial Fibrillation",{"date":31,"type":32},{"date":34,"type":32},{"date":83,"type":21},"2026-12-30",{"name":85,"class":39},"Biosense Webster, Inc.",10,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":94,"minAge":48,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"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",{"count":96,"type":21},1440,[52],"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.",[100,101],"Prostate Cancer","Prostatic Neoplasms",{"date":31,"type":32},{"date":104,"type":32},"2025-05-13",{"date":106,"type":21},"2031-01-06",{"name":108,"class":39},"Merck Sharp & Dohme LLC",290,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100053627","phase-3-a-study-to-test-the-efficacy-and-safety-of-riliprubart-against-the-usual-treatment-of-intravenous-immunoglobulin-ivig-in-people-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100053627","NCT06290141","A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy","VITALIZE","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)\u002FPeripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).\n* Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee.\n* Participants must have responded to IVIg in the past 5 years.\n* Participant must be on a stable maintenance dosage of IVIg.\n* Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT).\n* Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN\u002FPNS 2021 CIDP guidelines.\n* Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline.\n* Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥2 points at Screening.\n* Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention.\n* Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant\n* Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive.\n* Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Polyneuropathy of other causes, including but not limited to acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to IgM monoclonal gammopathy, POEMS syndrome, lumbosacral radiculoplexus neuropathy.\n* Sensory CIDP, distal CIDP and focal CIDP variants.\n* Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.\n* Poorly controlled diabetes\n* Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring antimicrobial treatment during Screening, or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections).\n* Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.\n* Any contraindication related to the administration of immunoglobulins (eg hypersensitivity, chronic kidney disease, thromboembolic diseases or recent thromboembolic event, known history of IgA deficiency at the time of Screening).\n* Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact the benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per the Investigator's judgment.\n* Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on the C-SSRS during Screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.\n* Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse.\n* Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.\n* Recent treatment with plasma exchange\n* Treatment within 3 months prior to dosing with immunosuppressive\u002F immunomodulator medication, or corticosteroids (with exception of maintenance dose, which is allowed), or prior treatment (at any time) with highly immunosuppressive\u002F chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine).\n* Prior treatment with riliprubart.\n* Recent use of any specific complement system inhibitor (eg, eculizumab).\n* Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation.\n* Prior treatment with B-cell depleting agents such as rituximab within 6 months.\n* Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening).\n* Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product (whichever is longer) prior to Screening.\n* Any Screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial.\n* Positive result of any of the following tests:\n\n  * hepatitis B surface antigen (HbsAg).\n  * anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \\[anti-HBs Ab\\] are also positive, indicating natural immunity).\n  * anti-hepatitis C virus (anti-HCV) antibodies. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained.\n  * anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies.\n* Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.\n* Accommodation in an institution because of regulatory or legal order; imprisoned or legally institutionalized.\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.\n* Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.\n* Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol.\n* Recent treatment with efgartigimod.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":119,"type":21},160,[52],"The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.",[123],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":31,"type":32},{"date":126,"type":32},"2024-08-21",{"date":128,"type":21},"2029-01-12",{"name":130,"class":39},"Sanofi",129,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100053362","phase-1-a-study-of-inlexisertib-dcc-3116-in-combination-with-anticancer-therapies-in-participants-with-advanced-malignancies-100053362","NCT05957367","A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies","A Master Protocol for the Multi-Cohort, Phase 1\u002F2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies","Inclusion Criteria:\n\n* Male or female ≥18 years of age\n* Module A: Part 1 and Part 2:\n\nModule A Part 1 and Part 2 inlexisertib combination closed on January 8, 2024, with no participants enrolled.\n\n* Module B: Only for Part 1 (Safety\u002FDose-finding):\n\n  * Pathologically confirmed diagnosis of GIST with a KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation\n  * Must have progressed on at least one approved systemic regimen given in the locally advanced or metastatic setting or have documented intolerance to it\n  * Must not have received prior ripretinib treatment\n* Module B: Only for Part 2 (Expansion)\n\n  * Pathologically confirmed GIST with documented mutation in KIT exon 11\n  * Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST\n* Must have at least 1 measurable lesion according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)\n* Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1\n* Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening\n* Must provide a fresh tumor biopsy, if able\n\nExclusion Criteria:\n\n* Must not have received the following within the specified time periods prior to the first dose of study drug:\n\n  1. Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the medication (whichever is longer)\n  2. Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication (whichever is shorter)\n  3. Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for drug-drug interactions and late toxicities of prior therapy as low, the Sponsor's Medical Monitor may approve a shorter washout of 14 days\n  4. Grapefruit or grapefruit juice: 14 days\n* Have not recovered from all clinically relevant toxicities from prior therapy\n* New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug\n* Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease\n* Malabsorption syndrome\n* Radiation for indications other than bone disease must have been completed 4 weeks prior to first dose of study drug, unless it consisted of limited field palliative radiation, including whole brain radiation, which must have been completed at least 2 weeks prior to first dose of study drug\n* Major surgery within 4 weeks of the first dose of study drug\n* Active HIV, Hepatitis B or Hepatitis C infection",{"count":140,"type":21},94,[142,24],"PHASE1","This is a Phase 1\u002F2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of inlexisertib in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of inlexisertib with other anticancer agents.",[145],"GIST",[147,148,149],"Advanced gastrointestinal stromal tumors","gastrointestinal stromal tumors","ripretinib",{"date":31,"type":32},{"date":152,"type":32},"2023-09-28",{"date":154,"type":21},"2029-03",{"name":156,"class":39},"Deciphera Pharmaceuticals, LLC",27,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":174,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100053764","phase-3-a-study-of-vepugratinib-ly3866288-in-participants-with-cancer-in-the-urinary-tract-100053764","NCT07218380","A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract","FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration","FORAGER-2","Inclusion Criteria:\n\n* Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present.\n* Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer.\n* Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Have adequate laboratory parameters\n\nExclusion Criteria:\n\n* Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC).\n* Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events (\\[CTCAE\\] version 5.0) from prior neoadjuvant or adjuvant systemic therapy.\n* Have ongoing sensory or motor neuropathy of Grade 2 or higher\n* Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.\n* Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.",{"count":167,"type":21},450,[52],"The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread.\n\nVepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab.\n\nStudy participation could last up to approximately 6 years.",[171,172,173],"Carcinoma, Transitional Cell","Urinary Bladder Neoplasms","Neoplasm Metastasis",[175,176,177],"FGFR3","Advanced Urothelial Carcinoma","Metastatic Urothelial Carcinoma",{"date":31,"type":32},{"date":180,"type":32},"2025-12-12",{"date":182,"type":21},"2033-05",{"name":184,"class":39},"Eli Lilly and Company",286,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":72,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"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.",{"count":195,"type":21},256,[52],"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).",[123],{"date":31,"type":32},{"date":201,"type":32},"2025-02-10",{"date":203,"type":21},"2030-12-31",{"name":205,"class":39},"Dianthus Therapeutics",180,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":215,"minAge":48,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100053966","phase-2-a-study-to-assess-adverse-events-and-change-in-disease-activity-of-multiple-treatment-combinations-with-intravenous-mirvetuximab-soravtansine-in-adult-participants-with-ovarian-cancer-100053966","NCT07059845","A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer","FLORENZA","Inclusion Criteria:\n\nSubstudy 1\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.\n\n  2L participants must have platinum-sensitive high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of most recent platinumbased chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.\n* Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with BRCA wild-type will need to have a local HRD test result available.\n\nSubstudy 2\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.\n* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.\n* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.\n\nSubstudy 3\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.\n* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.\n* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.\n\nExclusion Criteria:\n\nSubstudy 1\n\n* Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.\n* Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.\n* Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi).\n\nSubstudy 2\n\n* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:\n\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.\n  * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).\n  * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy\n  * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)\n* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.\n\nSubstudy 3\n\n* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:\n\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.\n  * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).\n  * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy\n  * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)\n* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.","FEMALE",{"count":217,"type":21},400,[24],"Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.\n\nMirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 3 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 participants will be enrolled in the study at 100 sites around the world.\n\nParticipants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused carboplatin and Bev, or IV infused Bev alone. The total study duration will be approximately 40 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.",[221],"Ovarian Cancer",[221,223,224,225],"Mirvetuximab Soravtansine","Bevacizumab","Carboplatin",{"date":31,"type":32},{"date":228,"type":32},"2025-11-13",{"date":230,"type":21},"2029-01",{"name":232,"class":39},"AbbVie",77,{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":249,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":259},"100053980","comprehensive-left-atrial-appendage-occlusion-with-rhythm-restoration-100053980","NCT07523620","Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration","CLEAR","Inclusion Criteria:\n\n* Subject must provide written informed consent prior to any clinical investigation-related procedure.\n* 18 years of age or older, or the age of legal consent\n* CHA2DS2-VASc score of ≥ 3 for women and ≥ 2 for men\n* Able to stop anticoagulation by 90 days post index procedure\n* Able to adhere to the protocol defined post-concomitant procedure pharmacologic regimen of OAC for at least 60 days followed by SAPT\n* Plans to undergo a catheter ablation procedure including PVI due to symptomatic, recurrent, drug-refractory PAF or PersAF\n* Documented symptomatic PAF or PersAF. Documentation requirements are as follows:\n\nParoxysmal:\n\n* Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 12 months prior to enrollment AND\n* One electrocardiographically documented PAF episode within 12 months prior to enrollment.\n\nPersistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by\n\n* Physician's note, AND either\n* 24-hour Holter within 180 days prior to enrollment, showing continuous AF, OR\n* Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:\n\n  * That are taken at least 7 days apart but less than 12 months apart\n  * If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent\u002Fenrollment\n  * The most recent electrocardiogram must be within 180 days of enrollment.\n\nNOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.\n\nExclusion Criteria:\n\n* Known contraindication or allergy to NOACs or aspirin, preventing use of the drugs post-procedure\n* Required to take P2Y12 platelet inhibitor after the study procedure (e.g., due to percutaneous coronary intervention)\n* Patients with heart prosthetic valves\n* Patient implanted with an inferior vena cava filter\n* Patients with left ventricular ejection fraction ≤30%\n* Patients with NYHA Class IV heart failure\n* Patients who have undergone any invasive intervention or surgery within 30 days prior to the index procedure (diagnostic catheterization is not within scope, however, percutaneous coronary intervention is within scope)\n* Patients who have experienced stroke or transient ischemic attack within 90 days prior to study procedure\n* Patients who have had previous attempt at LAA surgical or epicardial intervention (e.g., stapling, suturing, ligation, epicardial LAA management device)\n* Patients previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)\n* Patients with arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures within 90 days prior to the study procedure\n* Patients unable to receive heparin or an acceptable alternative to achieve adequate intra-procedural anticoagulation\n* Patients with a stent, constriction, or stenosis in a pulmonary vein\n* Patients with severe mitral regurgitation (regurgitant volume ≥ 60 mL\u002Fbeat, regurgitant fraction ≥ 50%, and\u002For effective regurgitant orifice area ≥ 0.40cm2)\n* Patients with severe renal failure (estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73m2) or on chronic dialysis\n* Patients with severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n* Patients with hypertrophic cardiomyopathy (maximal LV wall thickness ≥ 15 mm in the absence of abnormal loading conditions such as hypertension or aortic stenosis)",{"count":242,"type":21},240,[76],"The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.",[246,247,248],"Atrial Fibrillation (AF)","Paroxysmal AF","Persistent Atrial Fibrillation",[250,79,251,248],"Left Atrial Appendage","Paroxysmal Atrial Fibrillation",{"date":31,"type":32},{"date":254,"type":32},"2026-03-31",{"date":256,"type":21},"2028-02-28",{"name":258,"class":39},"Abbott Medical Devices",16,{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100053904","phase-3-a-non-inferiority-pharmacokinetic-and-safetytolerability-study-of-two-different-doses-of-weekly-sc-alpha1-pi-15-compared-with-corresponding-standard-iv-alpha1-pi-in-participants-with-alpha1-antitrypsin-deficiency-aatd-100053904","NCT07555483","A Non-inferiority Pharmacokinetic and Safety\u002FTolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)","An Open-Label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety\u002FTolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients With Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg\u002Fkg\u002FWeek and 120 mg\u002Fkg\u002FWeek Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)","SWIFT-SC","Inclusion Criteria:\n\n* Have a diagnosis of congenital AATD with an allelic combination of ZZ, SZ, Z(null), (null)(null), S(null), or \"at-risk\" alleles (patients with \"at-risk\" alleles must be individually evaluated for eligibility by the Medical Monitor). If the genotype has yet to be documented, a blood draw for genotyping (i.e., allelic discrimination) and phenotyping will be obtained at the Screening Visit.\n* Participants may be naïve to alpha1-PI augmentation therapy or may be currently receiving alpha1-PI augmentation therapy or received alpha1-PI augmentation therapy in the past. If the total alpha1-PI serum (alpha-1 antitrypsin \\[AAT\\]) level has yet to be documented as in a treatment-naïve patient, a blood draw for total alpha1-PI serum level will be obtained at the Screening Visit. For participants currently receiving alpha1-PI augmentation, a pre-alpha1-PI augmentation AAT level must be documented in the participant's medical history\u002Frecords.\n* All participants must have a documented total alpha1-PI serum level \\\u003C11 μM (80mg\u002FdL if measured by radial immunodiffusion or 50 mg\u002FdL if measured by nephelometry) which is documented pre-alpha1-PI augmentation for participants receiving AAT augmentation.\n* At the Screening Visit, have post-bronchodilator Forced Expiratory Volume in 1 second (FEV₁) ≥25% and \\\u003C80% predicted of predicted FEV₁\u002FForced Vital Capacity (FVC) \\\u003C70% (Global Initiative for Chronic Obstructive Lung Disease \\[GOLD\\] stage II-III, and some individuals are GOLD stage IV).\n* If the participant has received alpha1-PI augmentation therapy of any kind, he\u002Fshe must be willing to discontinue that treatment at the Week 1 (Baseline) Visit and remain off any kind of alpha1-PI treatment, other than the IPs of this study, while participating in the study.\n* Willing and able to provide written informed consent indicating that they understand the purpose of, and procedures required for the study and are willing to participate in it.\n\nExclusion Criteria:\n\n* Have had a moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation during the 4 weeks before the Week 1 (Baseline) Visit.\n* Have history of lung or liver transplant or on transplantation waiting list.\n* Have any lung surgery during the past 1 year (excluding lung biopsy).\n* At screening, have elevated liver enzymes (aspartate aminotransferase \\[AST\\], alanine aminotransferase \\[ALT\\], and alkaline phosphatase \\[ALP\\]) ≥ 2.5 times the upper limit of normal (ULN).\n* Have severe concomitant disease (e.g., congestive heart failure, clinically significant pulmonary fibrosis, malignant disease \\[except for skin cancers other than melanoma\\], history of acute hypersensitivity pneumonitis reaction, or current chronic hypersensitivity pneumonitis).\n* Females who are pregnant, breastfeeding or, if of child-bearing potential†, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), condom or occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, male sterilization, or true abstinence\\*) throughout the study. †Women of childbearing potential are defined as premenopausal and not surgically sterile, post tubal ligation, nor documented as infertile due to a concurrent medical condition.\n\n  \\*True abstinence: When this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\], declaration of abstinence for the duration of a study, and withdrawal are not acceptable methods of contraception.)\n* Have known previous infection with or clinical signs and symptoms consistent with current Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) infection.\n* Have smoked during the past 6 months (this includes electronic\u002Fvapor cigarettes) or a positive urine cotinine test at the Screening Visit that is due to smoking.\n* Received IP in another study within 30 days prior to the Week 1 (Baseline) Visit or received any recombinant human AAT-Fc fusion protein (e.g., INBRX-101) or other extended half-life AAT products within 5 half-lives of the product relative to the Screening Visit date.\n* Have history of anaphylaxis or severe systemic response to any plasma-derived alpha1- PI preparation or other blood product(s).\n* Use systemic steroids above a stable dose equivalent to 5 mg\u002Fday prednisone (i.e., 10 mg every 2 days) within the 4 weeks prior to the Week 1 (Baseline) Visit (Note: inhaled steroids are not considered systemic steroids). It is recommended to maintain the same dose throughout the study.\n* Use systemic or aerosolized antibiotics for a COPD exacerbation within the 4 weeks prior to the Week 1 (Baseline) Visit.\n* Have known selective or severe Immunoglobulin A (IgA) deficiency based on prior medical records.\n* In the opinion of the Investigator, the participant may have compliance problems or any medical condition that may place them at safety risk with the protocol and the procedures of the protocol, or because of unstable health be unable to come to the study site for in-person clinic visits required by the protocol.","80 Years",{"count":270,"type":21},40,[52],"This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein.\n\nAdults with Alpha-1 Antitrypsin Deficiency will take part. Participants will be randomly assigned to one of the treatment groups, and both the study doctors and participants will know which treatment is being given.\n\nThe main goals of the study are to understand how the body processes the medicine (pharmacokinetics) and to assess how safe and well tolerated the different weekly doses are.",[274],"Alpha 1 Antitrypsin Deficiency",[276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294],"Phase 3","Clinical Trial","Alpha1-Proteinase Inhibitor (Human)","Alpha 1-Antitrypsin","Subcutaneous","Intravenous","Pulmonary Emphysema","Emphysema","Pathologic Processes","Pulmonary Disease, Chronic Obstructive","Lung Diseases, Obstructive","Lung Diseases","Respiratory Tract Diseases","Genetic Diseases, Inborn","Subcutaneous Emphysema","Serine Proteinase Inhibitors","Protease Inhibitors","Enzyme Inhibition","Molecular Mechanisms of Pharmacological Action",{"date":31,"type":32},{"date":297,"type":32},"2026-05-05",{"date":299,"type":21},"2027-09-30",{"name":301,"class":39},"Grifols Therapeutics LLC",22,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":317,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"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":167,"type":21},[52],"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).",[315,316],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[318,319,320,321,322,323,324,325],"NSCLC","Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":31,"type":32},{"date":328,"type":32},"2025-07-17",{"date":330,"type":21},"2029-12",{"name":332,"class":39},"Nuvalent Inc.",156,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":347,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":355},"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":342,"type":21},1046,[52],"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.",[346],"Diffuse Large B-Cell Lymphoma",[348],"Lymphoma, Large B-Cell, Diffuse",{"date":31,"type":32},{"date":351,"type":32},"2025-01-27",{"date":353,"type":21},"2032-03-29",{"name":108,"class":39},266,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":369,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":380},"100054110","phase-3-bomedemstat-vs-hydroxyurea-for-essential-thrombocythemia-mk-3543-007-100054110","NCT06456346","Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)","A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) Versus Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants","Inclusion Criteria:\n\n* Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status\n* Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis\n* Has received no prior cytoreductive treatment for their ET\n* Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy\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\n* Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\n* History of any illness\u002Fimpairment of gastrointestinal function that might interfere with drug absorption\n* History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has an active infection requiring systemic therapy\n* Has had a major surgery \\\u003C4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery \\>4 weeks prior to first dose",{"count":364,"type":21},300,[52],"The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.",[368],"Essential Thrombocythemia",[370,371,372,373],"essential thrombocythemia","ET","bomedemstat","IMG-7289",{"date":31,"type":32},{"date":376,"type":32},"2024-07-16",{"date":378,"type":21},"2028-03-24",{"name":108,"class":39},171,{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":268,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":398,"leadSponsor":400,"locationsCount":402},"100054145","phase-3-a-clinical-study-to-compare-bupizenge-with-lidocaine-for-pain-due-to-oral-mucositis-in-patients-with-head-and-neck-cancer-100054145","NCT07672236","A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.","A Randomized, Open-label, Phase III Trial to Assess the Efficacy and Safety of BupiZenge Compared to Lidocaine for Pain Associated With Oral Mucositis in Head and Neck Cancer","BEAM-Pain","Inclusion Criteria:\n\n* Participant must provide signed written informed consent prior to trial participation and must be willing and able to comply with all requirements and restrictions of the trial.\n* Male or female aged ≥ 18 on the day of consent and ≤ 80 on the first day of dosing.\n* Pathologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx.\n* About to start IMRT with curative intent with daily fractions of 2.0 Gy to 2.2 Gy to a cumulative intended dose of at least 60 Gy and a maximum of 72 Gy. Proton therapy given at equivalent biological doses is allowed.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.\n* Female participants of childbearing potential (WOCBP) must agree to use a highly effective contraceptive measure or practice total sexual abstinence from the time of giving informed consent until at least 24 hours after last dose of IMP.\n\nExclusion Criteria:\n\n* Participation in another investigational interventional clinical trial within 3 months prior to first dosing, or for a longer period if required by local regulations, or within 5 half-lives of the investigational agent taken (whichever is longer). An exception is studies where patients are randomized to different radiotherapy settings, e.g. participation in DAHANCA 35 is allowed.\n* Previous radiation therapy to the head and\u002For neck area.\n* Pre-existing OM, active herpes simplex virus (HSV) infection, or untreated or uncontrolled oral candidiasis.\n* Receiving high-dose (\\> 15 mg per day prednisolone), corticosteroids (for any indication).\n* Known allergy or intolerance to bupivacaine, lidocaine, or any of the excipients in the products.\n* Significant cardiac disease such as AV block II-III or requiring treatment with antiarrhythmic drugs in class III (e.g., amiodarone).\n* Inability to eat or drink, or dependence on an enteral feeding tube (percutaneous endoscopic gastrostomy \\[PEG\\] or nasogastric tube) for any reason.\n* Moderate\u002Fsevere liver or kidney disease defined as:\n\n  1. AST\u002FALT \\> 3 × upper limit of normal (ULN) or bilirubin \\> 1.5 × ULN (unless related to Gilbert's syndrome)\n  2. glomerular filtration rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* Known diagnosis of epilepsy.\n* Known phenylketonuria (PKU).\n* Pregnancy or breastfeeding.\n* Any condition or circumstance-based on the investigator's assessment-that could increase risk to the participant, confound trial results, or interfere with compliance \u002F participation (including inability or unwillingness to follow trial procedures, or any clinically significant physical or psychiatric condition).",{"count":390,"type":21},150,[52],"Most patients who receive radiation therapy for head and neck cancer develop painful sores in the mouth called oral mucositis. For many of them, these sores are severe and result in debilitating pain. The sores usually start in the third week of radiation and last aboutfive weeks, often continuing for two weeks after treatment ends. Current pain treatments, for instance lidocaine solution, only give short-lasting pain relief.\n\nBupiZenge is a lozenge that dissolves slowly in the mouth and contains bupivacaine. Bupivacaine is a long-acting pain-relieving medicine and has been safely used for many years for both children and adults, and its safety profile is well understood. The BupiZenge lozenge is designed to give longer and more reliable pain relief for patients with mucositis in their mouth.\n\nThis study will check if BupiZenge works better to reduce pain than lidocaine, and if better pain control improves quality of life and reduces the need for strong pain medicines like opioids.\n\nThe main goal is to see how much mouth pain decreases after taking BupiZenge compared to lidocaine. This is measured by asking the patients to rate their pain score on a scale from 0 (no pain) to 10 (worst possible pain). This is done at different time-points, from before the dose until three hours after dose on the last day of radiotherapy.\n\nThe study will include 150 adults, both women and men, aged 18 to 80 years, who have head and neck cancer and are scheduled to receive radiotherapy, with or without chemotherapy. These patients will be randomly assigned to one of the treatment groups. The first is BupiZenge, which is a lozenge containing bupivacaine, which dissolves slowly in the mouth. The second is lidocaine, which is a liquid solution for use in the mouth that you gurgle or swish around in the mouth.\n\nThe study begins with a combined screening and run-in period that can last up to five weeks. During radiotherapy, patients record their mouth pain each day using a number scale from 0 (no pain) to 10 (worst possible pain). If the pain score is at least 4 (moderate pain) and they have developed mucositis in the mouth within 5 weeks, patients are randomly assigned to receive either BupiZenge or Lidocaine.\n\nTreatment continues at least until radiotherapy is completed. If the patient has pain and mouth sores, and the treatment is working well, it may continue after radiotherapy ends, but only until the sores heal or for a maximum of six weeks in total, whichever occurs first. After treatment ends, there is a 30-day follow-up period.",[394,395],"Head & Neck Cancer","Oral Mucositis",{"date":31,"type":32},{"date":59,"type":32},{"date":399,"type":21},"2027-01-31",{"name":401,"class":39},"OncoZenge AB",11,{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":22,"phases":413,"briefSummary":414,"conditions":415,"keywords":419,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":434},"100054235","phase-3-zilebesiran-in-patients-with-hypertension-not-adequately-controlled-and-with-either-established-cardiovascular-disease-or-high-risk-for-cardiovascular-disease-100054235","NCT07181109","Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH","Inclusion Criteria:\n\n* Is 18 years or older for patients with established cardiovascular disease (CVD)\n* Is 55 years or older for patients with high risk for CVD\n* Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD\n* Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic\n\nExclusion Criteria:\n\n* Has known history of secondary hypertension\n* Has symptomatic orthostatic hypotension\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3×upper limit of normal (ULN)\n* Has total serum bilirubin \\>1.5×ULN\n* Has international normalized ratio (INR) \\>1.5\n* Has serum potassium \\>4.8 mEq\u002FL\n* Has estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m\\^2",{"count":412,"type":21},11000,[52],"The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.",[416,417,418],"High Risk Cardiovascular Disease","Hypertension","High Cardiovascular Risk",[420,421,422,423,424,425,426],"High blood pressure","siRNA","Angiotensinogen","AGT","Cardiovascular disease","Uncontrolled hypertension","RNAi",{"date":31,"type":32},{"date":429,"type":32},"2025-09-22",{"date":431,"type":21},"2030-09-30",{"name":433,"class":39},"Alnylam Pharmaceuticals",995,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":22,"phases":444,"briefSummary":445,"conditions":446,"keywords":448,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":456,"locationsCount":458},"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":443,"type":21},525,[142],"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.",[447],"Advanced Solid Tumor",[449,450,451],"advanced solid tumor","BGB-58067","MTAP deficiency",{"date":31,"type":32},{"date":454,"type":32},"2025-01-10",{"date":299,"type":21},{"name":457,"class":39},"BeOne Medicines",96,{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":466,"maxAge":268,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":479},"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",{"count":468,"type":21},1200,[52],"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).",[472],"Crohn's Disease",{"date":31,"type":32},{"date":475,"type":32},"2024-06-05",{"date":477,"type":21},"2029-11-12",{"name":108,"class":39},499,{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":17,"minAge":487,"maxAge":488,"enrollmentInfo":489,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":502},"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":490,"type":21},342,[24,52],"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.",[494,495],"Heart Failure","Left Ventricular Systolic Dysfunction",{"date":31,"type":32},{"date":498,"type":32},"2023-05-31",{"date":500,"type":21},"2032-04-15",{"name":108,"class":39},107,{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":511,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":518,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":532},"100053717","phase-3-study-of-efficacy-and-safety-of-iptacopan-in-participants-with-ic-mpgn-100053717","NCT05755386","Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN","A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Idiopathic Immune-complex-mediated Membranoproliferative Glomerulonephritis (IC-MPGN)","APPARENT","Inclusion Criteria:\n\n* Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening).\n* Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only).\n* Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization\n* UPCR ≥ 1.0 g\u002Fg (≥ 113 mg\u002Fmmol) sampled from the first morning void urine sample at Day -75 and Day -15\n* Estimated GFR (using the chronic kidney disease \\[CKD\\]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 12 to 17 years) or measured GFR ≥ 30 ml\u002Fmin\u002F1.73m2 at screening and Day -15.\n* Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required, the vaccine should be given according to local regulations at least 2 weeks prior to the first administration of study treatment. If the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care.\n* If not previously vaccinated, or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration.\n\nExclusion Criteria:\n\n* Participants who have undergone cell or solid organ transplantation, including kidney transplantation.\n* Participants diagnosed with secondary IC-MPGN including but not limited to any of the following conditions:\n* Deposition of antigen-antibody immune complexes as a result of any chronic infections, including\n\n  * Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);\n  * Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections\n  * Protozoa\u002Fother infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis\n\nRenal deposition of immune complexes as a result of a systemic autoimmune disease:\n\n* Systemic lupus erythematosus (SLE)\n* Sjögren syndrome\n* Rheumatoid arthritis\n* Mixed connective tissue disease Deposition of monoclonal immunoglobulins because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.\n\nFibrillary glomerulonephritis\n\n* Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy.\n* Kidney biopsy showing interstitial fibrosis\u002Ftubular atrophy (IF\u002FTA) of more than 50%.\n* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or the presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.\n* A history of recurrent invasive infections caused by encapsulated organisms, e.g., Neisseria meningitidis and Streptococcus pneumoniae.\n* The use of inhibitors of complement factors (e.g., Factor B, Factor D, complement 3 (C3) inhibitors, anti-Complement 5 (C5) antibodies, C5a receptor antagonists) within 3 months or 5 half-lives prior to the Screening visit.\n* The use of immunosuppressants (except MPAs), cyclophosphamide or systemic corticosteroids at a dose \\>7.5 mg\u002Fday (or equivalent for a similar corticosteroid medication) within 90 days of study drug administration.\n* The use of MPAs is not permitted within 90 days prior to randomization in India, as per the local health authority requirement.\n* Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator.\n* Body mass index (BMI) \\>38 kg\u002Fm2 at screening and randomization. Body weight \\\u003C35 kg at screening and randomization","60 Years",{"count":513,"type":21},106,[52],"This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.",[517],"IC-MPGN",[519,517,520,521,522,523],"LNP023","iptacopan","UPCR","eGFR","proteinuria","2026-07-09",{"date":31,"type":32},{"date":527,"type":32},"2023-10-02",{"date":529,"type":21},"2029-05-31",{"name":531,"class":39},"Novartis Pharmaceuticals",131,{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":539,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":22,"phases":543,"briefSummary":544,"conditions":545,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":552},"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":542,"type":21},868,[52],"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.",[315],{"date":31,"type":32},{"date":548,"type":32},"2023-12-06",{"date":550,"type":21},"2035-12-21",{"name":108,"class":39},229,{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":22,"phases":562,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":570,"leadSponsor":572,"locationsCount":574},"100053553","phase-3-amaze-3-a-research-study-investigating-how-well-the-medicine-nnc0487-0111-helps-people-with-excess-body-weight-and-obstructive-sleep-apnoea-not-treated-with-positive-airway-pressure-lose-weight-and-improve-sleep-apnoea-100053553","NCT07571005","AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea","Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure (AMAZE 3)","AMAZE 3","Key Inclusion Criteria:\n\n* Male or female (sex at birth)\n* Age 18 years or above at the time of signing informed consent\n* Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening\n\nKey Exclusion Criteria:\n\n* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol\u002Fmol) as measured by the central laboratory at screening\n* History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records\n* Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy\n* Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence\n* Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1\u002Fgastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening",{"count":364,"type":21},[52],"This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.",[565,566,567],"Obesity","Overweight","Obstructive Sleep Apnoea",{"date":31,"type":32},{"date":297,"type":32},{"date":571,"type":21},"2028-10-04",{"name":573,"class":39},"Novo Nordisk A\u002FS",80,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":607},"100053289","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-remibrutinib-in-secondary-progressive-multiple-sclerosis-100053289","NCT07225504","A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis","A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis","REMASTER","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to any assessment performed.\n* Male or female participants aged 18-65 (inclusive) at Screening.\n* Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) at Screening\n* Absence of documented clinical relapses in the 24 months before Screening and randomization.\n* EDSS score of 3.0 to 6.0 (inclusive) at Screening.\n* Documented evidence of disability progression in the 12 months before Screening.\n\nExclusion Criteria:\n\n* Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).\n* History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).\n* Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.\n* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.\n* Women of childbearing potential (WOCBP), unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.\n* Significant bleeding risk or coagulation disorders, at Screening.\n* Use of exclusionary medication prior to Screening\u002Frandomization as listed in the protocol.\n\nOther protocol-defined inclusion\u002Fexclusion critria may apply","65 Years",{"count":585,"type":21},1275,[52],"The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)",[589],"Secondary Progressive Multiple Sclerosis (SPMS)",[591,592,593,594,595,596,597,598,599,600],"MS","Multiple sclerosis","secondary progressive multiple sclerosis","SPMS","remibrutinib","LOU064","adult","Expanded Disability Status Scale","EDSS","McDonald diagnostic criteria",{"date":31,"type":32},{"date":603,"type":32},"2025-11-11",{"date":605,"type":21},"2034-01-02",{"name":531,"class":39},236,{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":615,"enrollmentInfo":616,"targetDuration":4,"studyType":22,"phases":618,"briefSummary":619,"conditions":620,"keywords":624,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":637},"100054172","phase-1-study-of-eci830-single-agent-or-in-combination-in-patients-with-advanced-hrher2--breast-cancer-and-in-patients-with-other-advanced-solid-tumors-100054172","NCT06726148","Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+\u002FHER2- Breast Cancer and in Patients With Other Advanced Solid Tumors","An Open-label, Multi-center, Phase I\u002FII Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors","Inclusion Criteria:\n\nAge ≥ 18 years old.\n\nPatients with one of the following indications:\n\nPhase I:\n\nHR+\u002FHER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4\u002F6i and at least one additional line of systemic therapy for metastatic disease.\n\nHistologically and\u002For cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.\n\nPatients with ES-SCLC and disease progression on or after standard of care (SoC). For dose expansion only: no more than 2 prior lines of therapy for advanced or metastatic disease are allowed.\n\nPhase II:\n\nHR+\u002FHER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4\u002F6 inhibitor for unresectable\u002Fmetastatic disease with no more than 2 lines of endocrine therapy.\n\nMeasurable disease as determined by RECIST v1.1.\n\nBC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.\n\nExclusion Criteria:\n\nPrevious treatment with a CDK2 inhibitor at any time.\n\nPatients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n\nClinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.\n\nPresence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.\n\nFor the combination treatment:\n\nPatients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.\n\nPatients who could not tolerate the prescribed dose of ribociclib during a previous course of treatment, requiring dose reduction or permanent discontinuation due to adverse events.\n\nFor patients with BC: Patient is concurrently using hormone replacement therapy.\n\nWOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":617,"type":21},280,[142,24],"Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization\u002Frecommended dose for future studies.\n\nPhase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative (HR+\u002FHER2-) advanced breast cancer.",[621,622,623],"Advanced HR+\u002FHER2- Breast Cancer","Advanced CCNE1-amplified Solid Tumors","Extensive-stage Small Cell Lung Cancer",[625,626,627,628,629,630],"ECI830","Ribociclib","Fulvestrant","Breast cancer","CCNE1 amplification","Small cell lung cancer",{"date":31,"type":32},{"date":633,"type":32},"2025-04-03",{"date":635,"type":21},"2028-09-25",{"name":531,"class":39},33,{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":22,"phases":647,"briefSummary":648,"conditions":649,"keywords":651,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":661},"100054075","phase-1-a-study-to-assess-adverse-events-of-intravenously-iv-infused-etentamig-abbv-383-in-adult-participants-with-relapsed-or-refractory-multiple-myeloma-100054075","NCT05650632","A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma","A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of Etentamig (ABBV-383) in Subjects With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Must have measurable disease as outlined in the protocol.\n* Eastern Cooperative Oncology Group (ECOG) performance of \\\u003C= 2. Arm C and Arm D: ECOG performance of \\\u003C= 1.\n* Relapsed\u002Frefractory (R\u002FR) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.\n* Must be naïve to treatment with etentamig (ABBV-383).\n* Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.\n* Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \\[ADC\\] or chimeric antigen receptor T-cell \\[CAR-T\\] directed against BCMA).\n* Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).\n* Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).\n\nExclusion Criteria:\n\n* Arm A: Received BCMA-targeted therapy.\n* Arm C and Arm D: Rapidly progressing disease per investigator.",{"count":646,"type":21},210,[142],"Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of etentamig (ABBV-383) in adult participants with relapsed\u002Frefractory (R\u002FR) MM.\n\nEtentamig (ABBV-383) is an investigational drug being developed for the treatment of R\u002FR Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C \\& D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C \\& D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). Around 210 adult participants with relapsed\u002Frefractory multiple myeloma will be enrolled at approximately 50 sites across the world.\n\nParticipants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.",[650],"Multiple Myeloma",[650,652,653,654],"Cancer","ABBV-383","B-Cell Maturation Antigen",{"date":31,"type":32},{"date":657,"type":32},"2023-03-21",{"date":659,"type":21},"2029-08",{"name":232,"class":39},46,""]