2024-513533-20-00招募中3 期
A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn’s Disease or Ulcerative Colitis
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 137
- 试验地点
- 22
- 主要终点
- Percentage of participants discontinuing from study therapy due to AE
研究概览
简要总结
To evaluate the long-term safety and tolerability of tulisokibart
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Has participated in a qualifying MSD-sponsored tulisokibart Phase 2 or Phase 3 parent study for Crohn’s Disease or Ulcerative Colitis
- •The participant is judged to derive clinical benefit from continued study intervention as determined by the investigator based upon clinical evaluations performed during their parent study.
- •Assigned female sex at birth is eligible to participate if not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
- •A participant of childbearing potential is eligible if not pregnant and uses an acceptable form of contraception or abstinence
排除标准
- •Has prematurely discontinued from study intervention in the parent study
- •Has met any of the protocol-specified mandatory study intervention discontinuation criteria during the LTE Screening Period; or has an ongoing SAE from the parent study; or if in the opinion of the investigator, continued study participation poses unacceptable risk to the participant
- •Has received any protocol-defined prohibited concomitant medications
- •Is currently participating in an interventional clinical study other than a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
- •Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
研究组 & 干预措施
tulisokibart
Test
干预措施: tulisokibart (Drug)
Placebo to MK-7240 (Tulisokibart)
Placebo
干预措施: Placebo to MK-7240 (Tulisokibart) (Drug)
结局指标
主要结局
Percentage of participants discontinuing from study therapy due to AE
Percentage of participants discontinuing from study therapy due to AE
Percentage of participants with ≥1 adverse event (AE)
Percentage of participants with ≥1 adverse event (AE)
次要结局
- Percentage of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 364
- Percentage of participants achieving 2-patient-reported outcomes (PRO-2) remission per Crohn’s Disease Activity Index score at Week 364
- Percentage of participants achieving endoscopic remission per Simplified Endoscopic Score for Crohn’s Disease at Week 364
- Percentage of participants with UC achieving clinical remission per Modified Mayo Score at Week 364
研究者
Paulette Chandler
Scientific
Merck Sharp & Dohme LLC
研究点 (22)
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