CTRI/2026/02/104567招募中3 期
A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 882
- 试验地点
- 19
研究概览
简要总结
The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
This single study will be conducted as separate parts as mentioned below:
• A 12-week Double-blind Induction Study in Adults
• A 40-week Double-blind Maintenance Study in Adults
• A 52-week Open label Induction and Maintenance Study in Adolescents
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
- •Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy.
- •An endoscopy subscore greater than or equal to 2 as obtained during central review of the screening video endoscopy.
- •For adolescent participants greater than or equal to 12 to less than 18 years of age, body weight must be greater than equal to 40 kilograms (kg) at baseline (Week I-0)
- •A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
- •Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy ADT naive) or advanced therapy defined as biologics and or advanced oral agents for the treatment of UC (ADT-inadequate responder) as defined in the protocol.
排除标准
- •Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study
- •Presence of a stoma
- •Presence or history of a fistula
- •Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
- •History of extensive colonic resection (that is, less than 30 centimeter of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention.
研究者
Dr Sanish Davis
Johnson and Johnson Private Limited
研究点 (19)
Loading locations...
相似试验
Unknown
3 期
A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and or Serious InfectionsCTRI/2025/02/080276Novotech Clinical Research India Private Limited150
尚未招募
3 期
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )Subcutaneous FatNCT07526974Caliway Biopharmaceuticals Co., Ltd.320
尚未招募
1 期
A Study to Evaluate the Safety and Tolerability of Intravenous Stemis™ in Elderly Subjects With Mild to Moderate Frailty SyndromeNCT07462819Ji Yan Biomedical Co., Ltd.12
尚未招募
3 期
A Phase 3 Trial of JKN2401 Injection in COPDNCT07330310Joincare Pharmaceutical Group Industry Co., Ltd888
尚未招募
1 期
aKLmRNA-mediated Protein Replacement TherapyAgingNCT07544420Klothea Bio Inc21