[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Otsuka Pharmaceutical Development & Commercialization, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":319},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,41,71,96,119,152,174,197,218,240,272,296],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"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},"100584811","phase-3-a-trial-of-the-efficacy-and-safety-of-sep-363856-in-acutely-psychotic-participants-with-schizophrenia-100584811",false,"NCT06894212","A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia","A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia","Key Inclusion Criteria:\n\n* Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.\n* Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).\n* Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening\n\n  1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms.\n  2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.\n* Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:\n\n  1. Participant must have a PANSS total score ≥ 80\n\n     AND\n  2. Participant must have a CGI-S score ≥ 4.\n* Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.\n\nKey Exclusion Criteria:\n\n* Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.\n* Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.\n* Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.\n* Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study","ALL","18 Years","65 Years",{"count":20,"type":21},522,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia",[27],"Schizophrenia","RECRUITING","2026-06-25",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":32},"2025-02-28",{"date":36,"type":21},"2026-10-29",{"name":38,"class":39},"Otsuka Pharmaceutical Development & Commercialization, Inc.","INDUSTRY",73,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100642293","phase-1-a-trial-in-healthy-adult-participants-and-adults-with-autoimmune-disease-to-test-how-hbm7020-is-tolerated-and-absorbed-in-the-body-100642293","NCT07649265","A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body","A Phase 1 Open-Label, Multicenter Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HBM7020 in Healthy Adult Participants and Adults With Seropositive Autoimmune Disease","Key Inclusion Criteria for Healthy Participants (Part 1)\n\n1. Participants who are of non-childbearing potential or are using acceptable contraception.\n2. Body mass index (BMI) and body weight within an acceptable range.\n3. Good general health based on medical history, physical examination, electrocardiogram (ECG), and laboratory assessments.\n\nKey Disease-Agnostic Inclusion Criteria for Patient Participants (Part 1)\n\n1. BMI and body weight within an acceptable range.\n2. Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters.\n\nKey Disease-Specific Inclusion Criteria for Patient Participants (Part 1)\n\n1. Confirmed autoimmune disease with appropriate supporting autoantibody findings.\n2. Stable background therapy prior to dosing.\n3. Active moderate to severe disease consistent with protocol-defined disease activity criteria for:\n\n   * Systemic lupus erythematosus (SLE)\n   * Systemic sclerosis (SSc)\n   * Rheumatoid arthritis (RA)\n   * Sjögren's disease (SjD)\n\nKey Inclusion Criteria for Rescreening Participants (Part 2)\n\n1. Meets Part 1 disease-agnostic inclusion criteria.\n2. Stable background autoimmune therapy prior to dosing.\n3. Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria.\n\nKey Exclusion Criteria for Parts 1 and 2\n\n1. Pregnant or breastfeeding participants.\n2. Recent vaccination within protocol-defined timelines.\n3. Clinically significant medical history or abnormal physical examination findings.\n4. Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.\n5. Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.\n6. Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.",true,"75 Years",{"count":51,"type":21},63,[53],"PHASE1","This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement. Eligible participants include patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren's disease (SjD), and rheumatoid arthritis (RA).",[56,57,58,59],"Rheumatoid Arthritis","Systemic Lupus Erythematosus","Systemic Sclerosis","Sjögren's Disease",[61],"Autoimmune disease","NOT_YET_RECRUITING","2026-06-11",{"date":65,"type":32},"2026-06-16",{"date":67,"type":21},"2026-09-15",{"date":69,"type":21},"2028-11-20",{"name":38,"class":39},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":48,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100618284","phase-1-a-brain-imaging-study-to-assess-the-binding-of-msp-2020-to-serotonin-5-ht2a-receptors-in-healthy-male-adults-100618284","NCT07329621","A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults","A Phase 1, Open-label, Positron Emission Tomography (PET) Trial to Measure Serotonin 5-HT2A Receptor Occupancy Following Single Oral Doses of MSP-2020 in Healthy Male Adults","Inclusion Criteria\n\n1. Able to stay in the CRU for up to 4 days.\n2. Body mass index (BMI) between 18.0 to 32.0 kg\u002Fm2 (inclusive).\n3. In good health as determined by: a. Medical history; b. Physical and neurological examination; c. Concomitant medications; d. ECG; e. Screening echocardiogram; f. Serum chemistry, urinalysis, haematology, coagulation, and serology (HIV screen, HBsAg, and anti-HCV) tests.\n\nExclusion Criteria\n\n1. In first-degree relatives, a history of any schizophrenia-spectrum disorder, psychotic disorder, or bipolar and related disorders.\n2. History of allergy to tracer \\[11C\\]CIMBI-36.\n3. MRI incompatibility due to implants including but not limited to pacemaker, artificial joints, or non-removable body piercings, and\u002For other contraindications for MRI such as claustrophobia, metal objects\u002Ffragments, or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals (eg, welding), or have motor problems that prevent the participant from lying still for the MRI.\n4. Pathological MRI findings that would preclude from trial participation.\n5. History of prior radiation exposure for research purposes such that participation in this trial would result in an ionising radiation exposure of \\> 10 mSv within a year (12 months) of the first PET scan that would cause the participant to exceed the yearly dose limit.\n6. Have a negative modified Allen test at screening.\n7. Contraindications to radial arterial cannula (including but not limited to cellulitis or other infections over the radial artery, absence of palpable radial artery pulse, or a clinically significant abnormal coagulation profile).\n8. Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, haematologic, dermatologic, and immunologic disease.\n9. History of alcohol and\u002For substance use disorder within the last 24 months according to the Diagnostic Statistical Manual of Mental Disorders and in past medical history or in the investigator's opinion, or intake of \\> 21 units of alcohol weekly, and the inability to refrain from alcohol use from 48 hours before screening and within 72 hours prior to dosing until discharge from the CRU on Day 2. One unit is equivalent to 1 (25 mL) measure of 40% spirits. For reference, one 330 mL bottle of 5% beer contains 1.7 units and a standard (175 mL) glass of 12% wine contains 2.1 units.\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply.","MALE","23 Years","55 Years",{"count":82,"type":21},18,[53],"This study is to see how well MSP-2020 attaches to specific targets in the brain called serotonin type 2A receptors (5-HT2AR). This study will also look at how much of the study drug (and its metabolite) is in the blood and how long the study drug stays in the blood, as well as the safety of MSP 2020.",[86],"Healthy Volunteers","2026-06-10",{"date":89,"type":32},"2026-06-12",{"date":91,"type":32},"2026-01-15",{"date":93,"type":21},"2027-02-11",{"name":38,"class":39},1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":95},"100627266","phase-1-a-trial-to-examine-the-interaction-of-repinatrabit-with-ethinyl-estradiolnorethindrone-metformincarbamazepine-rosuvastatin-and-methotrexate-when-administered-together-100627266","NCT07446400","A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol\u002FNorethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together","A Phase 1, 4-arm, Open-label, Drug-drug Interaction Trial to Evaluate the Pharmacokinetics of Repinatrabit Oral Tablets When Co-administered With Ethinyl Estradiol\u002FNorethindrone, Metformin, Carbamazepine, Rosuvastatin, and Methotrexate in Healthy Participants","Inclusion Criteria:\n\n1. Body mass index (BMI) from 18 to 35 kilograms per square meter (kg\u002Fm\\^2) (inclusive).\n2. Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females.\n3. In good health as determined by:\n\n   1. Medical history\n   2. Physical examination\n   3. ECG\n   4. Serum chemistry, urinalysis, hematology, and serology tests\n4. Willing to stay in the clinic for the required period and willing to be contacted for the safety follow-up via telephone contact.\n5. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.\n\nExclusion Criteria:\n\n1. Female participants of childbearing potential.\n2. Female participants who have used HRT within 60 days or hormonal contraceptives within 14 days prior to Day 1 (Arm 1 only).\n3. Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy.\n4. For Arm 3, participants who test positive for HLA haplotypes associated with carbamazepine-induced hypersensitivity (HLA-B\\*15:02, HLA-A\\*31:01, and HLA-B\\*15:11).\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply.",{"count":104,"type":21},48,[53],"The purpose of this study is to assess the drug-drug interaction (DDI) of repinatrabit with ethinyl estradiol\u002Fnorethindrone or norethisterone (EE\u002FNE), metformin, rosuvastatin, carbamazepine, and methotrexate in healthy participants.",[86],[109,110],"Phenylketonuria","Drug-Drug Interaction (DDI) study","2026-05-05",{"date":113,"type":32},"2026-05-06",{"date":115,"type":32},"2026-03-31",{"date":117,"type":21},"2026-06-15",{"name":38,"class":39},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},"100609069","phase-3-a-study-of-quabodepistat-containing-regimens-for-the-treatment-of-drug-resistant-pulmonary-tuberculosis-100609069","NCT07209761","A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis","A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of 4-month and 6-month Quabodepistat-containing Regimens for Rifampicin-resistant\u002FMultidrug-resistant Pulmonary Tuberculosis","QUANTUM-TB","Inclusion Criteria:\n\n1. Age ≥14 years\n2. Body weight ≥30.0 kg\n3. Able to provide written informed consent (if under 18, requires both participant assent and parent\u002Fguardian consent)\n4. Documented pulmonary TB: Mtb confirmed by Xpert MTB\u002FRIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')\n5. Rifampicin resistance confirmed by Xpert MTB\u002FRIF Ultra test\n6. Chest radiograph consistent with active TB disease\n7. Able to provide sputum sample\n8. Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose\n9. Willing to have HIV test (unless previous positive result confirmed)\n10. For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine\u002Femtricitabine, tenofovir) for ≥3 months, Viral load \\\u003C200 copies\u002FmL, and CD4 count \\>100 cells\u002FmL\n\nExclusion Criteria:\n\n1. Known\u002Fsuspected resistance to BDQ, PMD, LZD, or QBS\n2. Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months\n3. Severe extrapulmonary TB\n4. Abnormal laboratory values: ALT\u002FAST \\>2.5×ULN, Total bilirubin \\>1.5×ULN, eGFR \\\u003C60 mL\u002Fmin\u002F1.73m², Hemoglobin \\\u003C8 g\u002FdL, Platelets \\\u003C100,000 cells\u002Fmm³, WBC \\\u003C2.0×10⁹\u002FL, ANC \\\u003C1000 cells\u002FμL, and HbA1c \\>9.0%\n5. Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment\n6. Co-enrollment in other therapeutic trials\n7. QTcF \\>450 msec (males) or \\>470 msec (females)\n8. Clinically significant cardiovascular disorders\n9. Bleeding disorders\n10. Conditions interfering with X-ray or sputum assessment\n11. Drug allergies\u002Fhypersensitivity to study medications\n12. Pregnancy or breastfeeding\n13. Positive drug screen (case-by-case assessment for some substances)\n14. Serious mental disorders\n15. Karnofsky score \\\u003C60\n16. BMI \\\u003C16.0 kg\u002Fm²\n17. Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)\n18. Pulmonary conditions other than TB (silicosis, fibrosis)\n19. Active SARS-CoV-2 infection\n20. Use of prohibited medications\n21. Blood\u002Fplasma donation within 30 days\n22. Current use of herbal remedies or traditional medicines","14 Years",{"count":129,"type":21},532,[24],"This study aims to assess quabodepistat-based treatment regimens for RR\u002FMDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.",[133],"Pulmonary Tuberculosis",[133,135,136,137,138,139,140,141,142,143],"Quabodepistat","Bedaquiline","Pretomanid","Linezolid","Moxifloxacin","Fluoroquinolone-sensitive TB","Fluoroquinolone-resistant TB","Drug-resistant TB","Shortened TB treatment","2026-05-04",{"date":113,"type":32},{"date":147,"type":32},"2025-10-16",{"date":149,"type":21},"2028-09-29",{"name":38,"class":39},35,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100590769","phase-3-a-study-of-jnt-517-in-participants-with-phenylketonuria-pku-100590769","NCT06971731","A Study of JNT-517 in Participants With Phenylketonuria (PKU)","A Phase 3, Double-Blind, Randomized, Two-Period, Multicenter, Placebo-Controlled, Efficacy and Safety Study of JNT-517 for the Treatment of Participants With Phenylketonuria","Inclusion Criteria:\n\n1. Males and females ≥18 years of age on Day 1\n2. Clinical diagnosis of PKU\n3. Average of at least 3 plasma Phe levels (after \\>4-hour fast) during Screening period of ≥360 μmol\u002FL\n4. Not on pegvaliase within 4 weeks prior to Screening\n5. If on sapropterin or large neutral amino acids, such as PheBloc®, NeoPhe®, and PreKunil® at Screening, must be on a stable dose 4 weeks prior to Screening and for the entire study duration.\n6. Willing and able to maintain a stable diet in Phe and total protein (intact protein and medical food protein) and able to adjust diet through the duration of the study according to the Dietary Management Guidelines\n7. Body weight \\>40 kilograms (kg)\n8. If biologically female of childbearing potential:\n\n   1. Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test by Day 1\n   2. Must practice sexual abstinence, or if involved in any sexual intercourse that could lead to pregnancy, must agree to use 2 highly effective contraceptive methods from Screening until at least 30 days after the last study drug administration\n   3. If taking estrogen- or progesterone-based oral contraceptives, must agree to use 2 other highly effective methods of contraception or must agree to sexual abstinence during the study\n   4. Must refrain from donating ova during the course of the study and for 30 days after the last dose of the study drug.\n9. If a biologically female not of childbearing potential or postmenopausal, defined as follows:\n\n   1. Has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)\n   2. Has had amenorrhea for minimum of 1 year with confirmation by levels of follicle stimulating hormone testing\n   3. Has not achieved menarche (has not had first menstrual period). If a female achieves menarche during the study, she will need to follow the contraception requirement for females of childbearing potential\n10. If biologically male, must practice sexual abstinence, or if involved in any sexual intercourse that could lead to pregnancy, must agree to use highly effective contraceptive methods from Day 1 until at least 30 days after the last study drug administration and must refrain from donating sperm during the course of the study and for 30 days after the last dose of the study drug NOTE: No restrictions are required for biological males who have undergone a documented vasectomy at least 4 months prior to Screening. If the vasectomy procedure is not documented or was performed less than 4 months prior to Screening, males must follow the same contraception as for non-vasectomized participants.\n11. Participants with psychiatric illness must be well-controlled for the last 6 months prior to the Screening visit and if on medication, on stable medications for the last 3 months.\n12. Capable of giving signed informed consent or parent\u002Flegal guardian to provide informed consent and the participant to give assent and confirm able to comply with study procedures\n\nExclusion Criteria:\n\n* Exclusion Criteria\n\nParticipants will be excluded from the study if any of the following criteria are met:\n\n1. Any acute or uncontrolled chronic medical condition that would prevent the participant from complying with the procedures or place the participant at risk if they participate in the study\n2. Positive for hepatitis B or C or human immunodeficiency virus\n3. Any history of malignancy of any organ system (other than non-melanoma skin cancer or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases\n4. Any history of significant liver disease\n5. Any history of cataracts or more than minimal cataracts observed during the Screening ophthalmologic examination. Minimal cataracts are defined as changes similar to lens opacities classification system III (LOCS III), lens grade C1, N1 or P1\n6. Any surgical or medical conditions that may affect study drug absorption, distribution, metabolism, or excretion\n7. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2 by 2021 Chronic Kidney Disease Epidemiology Collaboration formula\n8. Participation in another investigational drug trial within 30 days or, if known, 5 half-lives of the investigational drug (whichever is longer). For gene therapy or editing trials, participants must have received the intervention \\>6 months prior to Screening visit and with stable plasma Phe in the past 2 months prior to Screening visit.\n9. Alcohol consumption within 5 days of randomization and\u002For unwilling to limit to 1 alcoholic drink per day until after the 6-month study visit\n10. History of drug\u002Falcohol abuse in the last year\n11. Use of any medications that are inhibitors or inducers of cytochrome P450 (CYP3A4) or inhibitors of the transporter P-glycoprotein (P-gp) within 4 weeks prior to randomization and unwilling and\u002For unable to avoid these medications throughout the treatment duration\n12. Use of any medications that are substrates of breast cancer resistance protein (BCRP), multidrug and toxin extrusion (MATE)1, or MATE2-K within 4 weeks prior to randomization and unwilling and\u002For unable to avoid these medications throughout the treatment duration NOTE: Participants will be permitted to continue with estrogen- or progesterone-based oral contraceptives, but must agree to use 2 other methods of contraception, where at least 1 must be highly effective, or must agree to sexual abstinence during the study.\n13. Current, recent, or suspected active viral or bacterial infection within 2 weeks prior to and during the Screening Period\n14. Unable to tolerate oral medication or have a condition that would interfere with the absorption of JNT-517\n15. Allergy to JNT-517 or any component of the investigational product\n16. Any of the following laboratory values at the Screening visit: -Alanine aminotransferase or aspartate aminotransferase values \\>1.5× the upper limit of normal (ULN)-Total bilirubin ˃ULN unless history of Gilbert Syndrome and then total bilirubin \\>4 milligrams per deciliter (mg\u002FdL) is exclusionary-Hemoglobin \\\u003C11.0 grams per deciliter (g\u002FdL) \\[\\\u003C110.0 grams per liter (g\u002FL)\\]-White blood cell count \\>ULN-Platelets \\\u003C150 × 10\\^9\u002FLiter (L) (\\\u003C150,000\u002Fcubic millimeters \\[mm\\^3\\]).",{"count":160,"type":21},120,[24],"The goal of this Phase 3, randomized study is to assess the safety, efficacy, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adults (18 years of age or older) with PKU. Participants will receive either JNT-517 or placebo and will be blinded to their treatment assignment. Participants will have a 2 in 3 (or approximately 67%) chance of receiving JNT-517 during the first part of the study which will last approximately six weeks. During the second part of the study every participant who continues in the study will receive one of two doses of JNT-517 for an additional 46 weeks. The study requires a screening period of up to 35 days to ensure dietary stabilization and amino acid levels required to meet study eligibility. In total, participation in the study could last for up to 400 days.\n\nParticipants will:\n\nTake 75 mg JNT-517 or 150 mg JNT-517, or a placebo BID (2x per day) for approximately 365 days; Visit the clinic or have a mobile health nurse visit your home for checkups and tests; Collect urine sample at home and bring to clinic on specified days; Keep a food diary 3 days before each study visit",[109],[109,165],"PKU","2026-04-28",{"date":144,"type":32},{"date":169,"type":32},"2025-10-20",{"date":171,"type":21},"2028-04-01",{"name":38,"class":39},25,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":181,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":5},"100564357","phase-3-a-long-term-study-of-jnt-517-in-participants-with-phenylketonuria-100564357","NCT06628128","A Long-Term Study of JNT-517 in Participants With Phenylketonuria","An Open-Label Study to Evaluate the Long-Term Safety of JNT-517 in Participants With Phenylketonuria","Key Inclusion Criteria:\n\n1. Diagnosis of phenylketonuria (ie, PAH deficiency) by either molecular testing or biochemical criteria consistent with the applicable regional guidelines.\n2. Participants 4 years of age and older, inclusive, at time of Screening.\n3. Not on pegvaliase within 4 weeks of Screening.\n4. Not on sepiapterin within 2 weeks of Screening.\n5. If on sapropterin or large neutral amino acids at Screening, must be on a stable dose for 4 weeks prior to Screening.\n6. Willing and able to maintain a diet consistent in Phe content from the Screening period through the duration of the study, unless otherwise directed by a dietician as allowed in the protocol.\n7. Body weight ≥ 12.5 kg.\n8. If female of childbearing potential:\n\n   1. Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test by Day 1.\n   2. Must practice sexual abstinence, or if involved in any sexual intercourse that could lead to pregnancy, must agree to use 2 different contraceptive methods, where at least 1 method must be highly effective, from Screening until at least 30 days after the last study drug administration.\n   3. Must refrain from donating ova during the course of the study and for 30 days after the last dose of the study drug.\n9. Is a female not of childbearing potential or postmenopausal, defined as follows:\n\n   1. Has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).\n   2. Has had amenorrhea for minimum of 1 year with confirmation by levels of follicle stimulating hormone testing.\n   3. Has not achieved menarche (has not had first menstrual period). If a female achieves menarche during the study, she will need to follow the contraception requirement for females of childbearing potential.\n10. If male, must practice sexual abstinence, or if involved in any sexual intercourse that could lead to pregnancy, must agree to use 2 different contraceptive methods, where at least 1 method must be highly effective, from Day 1 until at least 30 days after the last study drug administration and must refrain from donating sperm during the course of the study and for 30 days after the last dose of the study drug.\n\n    Note: No restrictions are required for males who have undergone a documented vasectomy at least 4 months prior to Screening. If the vasectomy procedure is not documented or was performed less than 4 months prior to Screening, males must follow the same contraception as for non-vasectomized participants.\n11. Capable of giving signed informed consent, or parent\u002Flegal guardian to provide informed consent and pediatric participant to give assent, and be able to comply with study procedures.\n12. Participants with psychiatric illness must be well-controlled for the last 3 months prior to screening visit and, if on medication, on stable medications for the last 3 months.\n\nKey Exclusion Criteria:\n\n1. Participation in this study is not considered safe and\u002For feasible in the opinion of the Investigator.\n2. Participants have not completed a previous JNT-517 study and are eligible for another active JNT-517 trial at the site, unless approval is obtained from the medical monitor.\n3. Any acute or chronic medical condition that would prevent the participant from complying with the procedures or place the participant at risk if they participate in the study.\n4. Positive for hepatitis B or C or human immunodeficiency virus.\n5. Any history of significant liver disease.\n6. Any history of cataracts or more than minimal cataracts observed during the Screening ophthalmologic examination.\n7. Any surgical or medical conditions that may affect study drug absorption, distribution, metabolism, or excretion.\n8. Estimated glomerular filtration rate \\\u003C 60 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2) by 2021 Chronic Kidney Disease Epidemiology Collaboration formula (participants aged 17 years or greater) or by Schwartz formula (participants aged 4 to 16 years of age).\n9. History of drug or alcohol abuse in the last year.\n10. Use of any medication that are inhibitors or inducers of cytochrome P450 (CYP)3A4 or inhibitors of the transporter P glycoprotein (P-gp) within 4 weeks prior to the first dose of study drug and unwilling and\u002For unable to avoid these medications throughout the treatment duration.\n11. Use of any medications that are a substrate of breast cancer resistance protein (BCRP), multidrug and toxin extrusion (MATE)1, MATE2-K, organic anion transporter 3 (OAT3), or CYP3A4 within 4 weeks prior to the first dose of study drug and unwilling and\u002For unable to avoid these medications throughout the treatment duration (Appendix A). CYP3A4 substrates may be allowed if reduction in exposure is not expected to impact safety of the participant after consultation with the Medical Monitor.\n\n    NOTE: Participants of childbearing potential will be permitted to continue with estrogen- or progesterone based oral contraceptives, but must agree to use 2 other methods of contraception, where at least 1 must be highly effective, or must agree to sexual abstinence during the study.\n12. Current, recent, or suspected infection within 2 weeks of Screening of Severe Acute Respiratory Syndrome Coronavirus 2\u002FCoronavirus Disease 2019 (SARS-CoV-2\u002FCOVID-19).\n13. Unable to tolerate oral medication or inability to swallow tablets.\n14. Allergy to JNT-517 or any component of the investigational product.\n15. Any of the following laboratory values at the Screening visit:\n\n    1. Alanine aminotransferase or aspartate aminotransferase values ˃ 1.5 x the upper limit of normal (ULN).\n    2. Total bilirubin ˃ULN unless history of Gilbert Syndrome and then total bilirubin \\>4 milligrams per deciliter \\[mg\u002FdL\\] is exclusionary.\n    3. Hemoglobin ˂10.0 g\u002FdL (˂100.0 grams per liter \\[g\u002FL\\])\n    4. White blood cell count ˃1 x ULN\n    5. Platelet count ˂150 × 109\u002FL (˂150,000\u002Fcubic millimeters\\[mm\\^3\\])\n16. Participation in another investigational drug trial within 30 days (other than for JNT-517) or, if known 5 half-lives of investigational drug (whichever is longer).","4 Years",{"count":183,"type":21},240,[24],"The goal of this Phase 3, open-label study is to evaluate the long-term safety of JNT-517 in pediatric and adult participants with Phenylketonuria (PKU) after completion of either Study JNT517-101 (NCT05781399) or JNT517-201 (NCT06637514) as well as participants who have not participated in a prior JNT-517 study. In this trial, all participants will receive JNT-517 using age- and weight-banded dosing as outlined in the protocol, regardless of any dose received in a previous study.",[187],"Phenylketonuria (PKU)",[109,165],"2026-04-27",{"date":191,"type":32},"2026-05-01",{"date":193,"type":32},"2025-08-11",{"date":195,"type":21},"2028-02-01",{"name":38,"class":39},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":80,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":4},"100633382","phase-1-a-study-in-adult-males-with-x-linked-congenital-nephrogenic-diabetes-insipidus-to-test-the-effects-of-ndi-5001-given-for-multiple-days-and-to-test-how-ndi-5001-is-tolerated-and-taken-up-in-the-body-100633382","NCT07525960","A Study in Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus to Test the Effects of NDI-5001 Given for Multiple Days and to Test How NDI-5001 is Tolerated and Taken up in the Body","A Phase 1b, Open-label Trial to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of NDI-5001 in a Capsule Following Daily Oral Doses to Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus","Inclusion Criteria\n\n1. X-linked congenital NDI with a genotype-confirmed arginine vasopressin receptor 2 (gene) (AVPR2) mutation and no mutation in aquaporin-2 (AQP2).\n2. Urine osmolality of ≤ 200 milliosmoles per kilogram of water (mOsm\u002Fkg) in a spot urine sample obtained from a first morning void upon awakening (at screening, check-in \\[Day -4\\], and Day -1) before consuming any food or drink after awakening.\n\n3\\) BMI between 18.0 to 32.0 kilograms per square meter (kg\u002Fm\\^2), inclusive.\n\nExclusion Criteria\n\n1. Participant who is not willing to follow a low-sodium (\\\u003C=1 gram\u002Fday) diet during the in-clinic portion of the trial.\n2. A positive drug screen for substances of abuse (including THC, cannabidiol) at screening or check-in.\n3. Estimated glomerular filtration rate \\\u003C60 milliliters per minute per 1.73-kilogram square meters by serum creatinine and cystatin C at screening.\n4. Participants who have taken an investigational drug within 30 days prior to screening.\n5. Previous exposure to NDI-5001.\n6. Any history of significant bleeding or hemorrhagic tendencies.\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria may apply.",{"count":205,"type":21},24,[53],"The primary purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NDI-5001 administered as a capsule following daily oral dosing in adult males with X-linked congenital nephrogenic diabetes insipidus (NDI) due to vasopressin receptor Type 2 (V2R) mutations.",[209],"X-linked Congenital Nephrogenic Diabetes Insipidus","2026-04-06",{"date":212,"type":32},"2026-04-13",{"date":214,"type":21},"2026-06-02",{"date":216,"type":21},"2027-04-14",{"name":38,"class":39},{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":48,"sex":78,"minAge":17,"maxAge":80,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":95},"100627934","phase-1-a-study-to-detect-the-radioactivity-of-14c-sep-380135-in-urine-and-feces-in-healthy-male-adults-100627934","NCT07455084","A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults","A Phase 1 Trial to Assess the Mass Balance and Pharmacokinetics of a Single Oral Administration of 14C-SEP-380135 in Healthy Male Adults","Inclusion Criteria:\n\n1. Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg\u002Fm²).\n2. In good overall health, based on:\n\n   1. Medical history\n   2. Physical examination\n   3. Neurological examination\n   4. Vital signs\n   5. Electrocardiogram (ECG)\n   6. Blood and urine tests (serum chemistry, hematology, urinalysis, serology)\n3. Regular daily bowel movements (at least one per day) for 30 days before Day -2.\n4. Ability to provide written informed consent and follow all study instructions.\n5. Has a stable living situation at screening and agrees to return to a similar living arrangement after the in-clinic stay.\n\nExclusion Criteria:\n\n1. Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.\n2. Have had prior exposure to SEP-380135.\n3. Are currently participating in another clinical trial.\n4. Attempted suicide within 12 months prior to screening.\n5. A history of sick sinus syndrome, any degree of atrioventricular block, Heart attack (myocardial infarction), heart failure (NYHA Class II-IV), cardiomyopathy, pulmonary congestion, cardiac arrhythmias, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia. A participant with non-clinically significant ECG abnormalities at screening and check-in requires approval from the medical monitor and the sponsor's physician.\n6. Are predicted poor metabolizer CYP2D6 phenotypes. Note: Other protocol-specified inclusion\u002Fexclusion criteria may apply.",{"count":226,"type":21},8,[53],"The purpose of the present trial is to obtain information on the absorption, distribution, metabolism, excretion and pharmacokinetics (PK) of 14C-SEP-380135 and its metabolites following a single oral dose.",[27],[231],"Mental Health Conditions, Schizophrenia","2026-03-03",{"date":234,"type":32},"2026-03-06",{"date":236,"type":21},"2026-03-20",{"date":238,"type":21},"2026-05-03",{"name":38,"class":39},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":247,"maxAge":17,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100422548","phase-3-a-study-to-see-iftolvaptan-is-safe-in-infants-and-children-who-at-enrollment-are-28-days-to-less-than-18-years-old-withautosomal-recessive-polycystic-kidney-disease-arpkd-100422548","NCT04782258","A Study to See Iftolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old withAutosomal Recessive Polycystic Kidney Disease (ARPKD)","A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)","Inclusion Criteria:\n\n1. Male or female subjects between 28 days and less than 18 years of age, with clinical features that are consistent with a diagnosis of ARPKD.\n2. Ability for parent\u002Flegal guardian to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial. Ability to provide written informed assent from all subjects old enough per local laws to provide assent.\n\nExclusion Criteria:\n\n1. Premature birth (≤ 32 weeks gestational age) for infants 28 days to \\\u003C 12 weeks of age.\n2. Anuria or RRT defined as intermittent or continuous hemodialysis, peritoneal dialysis, hemofiltration, hemodiafiltration or history of kidney transplantation.\n3. Evidence of syndromic conditions associated with renal cysts (other than ARPKD).\n4. Abnormal liver function tests including ALT and AST, \\> 1.2 × ULN (upper limit of normal).\n5. Has splenomegaly or portal hypertension (HTN).\n6. Parents with renal cystic disease.\n7. Receiving chronic diuretic that could not be adjusted after tolvaptan initiation.\n8. Cannot be monitored for fluid balance.\n9. Has or at risk of having sodium and potassium electrolyte imbalances, as determined by the investigator.\n10. Has or at risk of having significant hypovolemia as determined by investigator.\n11. Clinically significant anemia, as determined by investigator.\n12. Platelets \\\u003C 50000 µL.\n13. Severe systolic dysfunction defined as ejection fraction \\\u003C 14%.\n14. Serum sodium levels \\\u003C 130 mmol\u002FL or \\>145 mmol\u002FL.\n15. Taking any other experimental medications.\n16. Require ventilator support.\n17. Taking medications known to induce CYP3A4 (CYP = Cytochrome P).\n18. Having an infection including viral that would require therapy disruptive to IMP dosing.\n19. Females who are breast-feeding or who have a positive pregnancy test result prior to receiving IMP.\n20. Subjects with a history of substance abuse (within the last 6 months).\n21. Subjects who have bladder dysfunction and\u002For difficulty voiding.\n22. Subjects taking a vasopressin agonist (eg, desmopressin).\n23. Subjects with a history of persistent noncompliance with antihypertensive or other important medical therapy.\n24. Subjects taking medications or having concomitant illnesses likely to confound endpoint assessments, including taking approved (ie, marketed) therapies for the purpose of affecting PKD cysts such as tolvaptan, vasopressin antagonists, anti-sense ribonucleic acid (RNA) therapies, rapamycin, sirolimus, everolimus, or somatostatin analogs (ie, octreotide, sandostatin).\n25. Received or are scheduled to receive a liver transplant.\n26. History of cholangitis within the last 6 months.\n27. Has findings consistent with clinically significant portal hypertension (eg, varices, variceal bleeding, hypersplenism indicated by thrombocytopenia).","28 Days",{"count":249,"type":21},20,[24],"To evaluate the safety of tolvaptan in pediatric subjects with ARPKD",[253],"Autosomal Recessive Polycystic Kidney (ARPKD)",[255,256,257,258,259,260,261,262],"ARPKD","TOLVAPTAN","Polycystic Kidney Disease","Autosomal Recessive Polycystic Kidney Disease","Adolescent","Renal Cysts","Oligohydramnios","Anhydramnios","2026-02-13",{"date":265,"type":32},"2026-02-17",{"date":267,"type":32},"2023-01-23",{"date":269,"type":21},"2028-08-14",{"name":38,"class":39},23,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":295},"100577532","phase-1-a-phase-1-trial-to-evaluate-the-safety-tolerability-pharmacodynamics-pharmacokinetics-and-immunogenicity-of-vis171-in-participants-with-autoimmune-diseases-100577532","NCT06799520","A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s)","A Phase 1 Open-label Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Subcutaneous VIS171 in Participants With Autoimmune Disease(s)","Inclusion Criteria:\n\n1. Estimated glomerular filtration rate (eGFR) \\>30 milliliters\u002Fminute\u002F1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2) at the screening visit.\n\n   For SLE participants:\n2. Participant has a confirmed diagnosis of SLE according to European League Against Rheumatism\u002FAmerican College of Rheumatology SLE classification criteria ≥ 24 weeks prior to signing the informed consent form (ICF).\n\n   For AA participants:\n3. Current scalp involvement between 25% and 95%, inclusive (Severity of Alopecia Tool \\[SALT\\] score between 25 and 95, inclusive), at screening.\n4. Current episode of AA is of duration \\> 24 weeks (without evidence of spontaneous terminal hair regrowth at the time of screening and first treatment, i.e., no more than 10% regrowth), but ≤ 5 years from onset of current episode of severe scalp hair loss.\n\n   For FSGS participants:\n5. Prior biopsy (no time limit) showing histologic minimal change disease (MCD), FSGS, or MCD\u002FFSGS spectrum.\n6. History of at least one prior episode of nephrotic syndrome, defined as 24-hour urine protein \\> 3.5 grams per day (g\u002Fday) and serum albumin \\\u003C 3.5 grams per deciliter (g\u002FdL).\n7. History of steroid responsive nephrotic syndrome, including participants who achieved complete remission, partial remission, had a course of steroid dependent nephrotic syndrome or relapsing nephrotic syndrome (all defined as per the managing physician at the time of the episode).\n\nExclusion Criteria:\n\n1. Receipt of high-dose corticosteroid therapy within 4 weeks prior to screening as either (a) intravenous (IV) pulse corticosteroid therapy or (b) daily oral corticosteroid therapy of ≥ 1 milligrams per kilogram (mg\u002Fkg) or up to 40 milligrams per day (mg\u002Fday) prednisone (or equivalent).\n2. Receipt of blood products within 6 months prior to screening.\n3. Previous exposure to VIS171 or any other drug targeting interleukins (IL)-2 or the IL-2 receptor or T regulatory cells.\n4. History of or current diagnosis of catastrophic or severe anti-phospholipid syndrome (APS) within 1 year prior to signing ICF. SLE participants with APS adequately controlled by anticoagulant are eligible. SLE participants who are found to be triple positive for anti-phospholipid antibodies at screening (without clinical APS) will be excluded unless they are on stable anti-thrombotic therapy.\n5. Known primary immunodeficiency disorder.\n6. Participant has a history of Class V lupus nephritis.\n7. Receipt of anifrolumab, tumor necrosis factor-alpha monoclonal antibodies (\\[TNF\\]-α mAb), immunoglobulins (IV\u002FSC) plasmapheresis, or any other immunosuppressants (calcineurin inhibitors, Janus kinase \\[JAK\\] inhibitors or other kinase inhibitors), other than hydroxychloroquine, mycophenolic acid (MPA)\u002Fmycophenolate mofetil (MMF) and corticosteroids, within 6 months prior to screening.\n8. Participant has concomitant hair loss of another form, including but not limited to traction alopecia, central centrifugal cicatricial alopecia, lichen planopilaris, frontal fibrosing alopecia, or androgenetic alopecia.\n9. Participant has received (1) Within 12 weeks prior to Day 1: Systemic therapies (oral or injection), such as corticosteroids, JAK inhibitors, methotrexate, calcineurin inhibitors, oral minoxidil, low-dose IL-2 and topical immunotherapies such as psoralen plus UVA (PUVA) , diphenylcyclopropenone (DPCP), dinitrochlorobenzene (DNCB), intralesional steroids or (2) Within 4 weeks prior to Day 1: Other topical therapies, such as topical minoxidil, clobetasol etc. These therapies will also not be allowed during this trial.\n10. Steroid resistant nephrotic syndrome defined as absence of history of at least 1 episode of complete or partial remission following at least 12 weeks of full dose corticosteroid therapy.\n11. Receipt of anifrolumab, TNF-α mAb, immunoglobulins (IV\u002FSC) plasmapheresis, or any other immunosuppressants (JAK inhibitors or other kinase inhibitors).\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply.",{"count":280,"type":21},30,[53],"The purpose of this trial is to measure safety and tolerability of subcutaneous (SC) VIS171 in combination with standard of care in participants with autoimmune disease(s). The total duration of the clinical trial for each participant will be up to approximately 9 to 12 months.",[284,285,286],"Systemic Lupus Erythematosus (SLE)","Alopecia Areata (AA)","Immune-mediated Focal Segmental Glomerulosclerosis (FSGS)","2025-09-11",{"date":289,"type":32},"2025-09-17",{"date":291,"type":32},"2025-03-17",{"date":293,"type":21},"2027-03-01",{"name":38,"class":39},6,{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":303,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"100572996","phase-2-trial-of-the-impact-of-sibeprenlimab-on-immunoglobulin-a-nephropathy-kidney-tissue-100572996","NCT06740526","Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue","A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy","Inclusion Criteria:\n\n1. Participants must be at least 16 years of age or older at the time of signing the informed consent\u002Fassent.\n2. Source-verified kidney biopsy confirmed diagnosis of IgAN.\n3. Participant has estimated glomerular filtration rate (eGFR) \\> 45 mL\u002Fmin\u002F1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration \\[CKD EPI\\] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 \\[CKiD U25\\] eGFR equation for those younger than 18 years)\n\nExclusion Criteria:\n\n1. Participants who are breast-feeding and\u002For who have a positive pregnancy test result prior to receiving sibeprenlimab.\n2. Participant has coexisting chronic kidney disease, other than IgAN.\n3. Participant has a serum IgG value \\\u003C600 mg\u002FdL at screening.\n4. Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:\n\n   topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).\n5. Participant has uncontrolled hypertension (defined as systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg).\n6. Participants who would be likely to require prohibited concomitant therapy during the trial.","16 Years",{"count":173,"type":21},[306],"PHASE2","This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.",[309],"IgA Nephropathy","2025-04-04",{"date":312,"type":32},"2025-04-06",{"date":314,"type":32},"2024-11-19",{"date":316,"type":21},"2029-04-17",{"name":38,"class":39},5,""]