A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,380
- 试验地点
- 74
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants in "Group 1: Low Dose Unblinded" and "Group 2: High Dose Unblinded" received open-label treatment on their parent studies, and will remain unblinded on this extension study.
Participants in "Group 3: High Dose Blinded" and "Group 4: Low Dose Blinded" were all blinded on their parent studies, and will remain blinded on this extension study until after regulatory approval or market authorization in the United States or European Medicines Agency, per sponsor discretion.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
- •The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
- •A participant assigned female sex at birth is 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 (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
- •A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)
排除标准
- •Has prematurely discontinued study intervention in their parent study
- •Has received any protocol-specified prohibited medications during their parent study
- •Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
研究组 & 干预措施
Group 4: Low Dose Blinded
Participants receive a blinded low dose SC tulisokibart regimen.
干预措施: Placebo to tulisokibart (Drug)
Group 2: High Dose Unblinded
Participants receive a high dose SC tulisokibart regimen.
干预措施: Tulisokibart (Drug)
Group 3: High Dose Blinded
Participants receive a blinded high dose SC tulisokibart regimen.
干预措施: Tulisokibart (Drug)
Group 4: Low Dose Blinded
Participants receive a blinded low dose SC tulisokibart regimen.
干预措施: Tulisokibart (Drug)
Group 1: Low Dose Unblinded
Participants receive a low dose subcutaneous (SC) tulisokibart regimen.
干预措施: Tulisokibart (Drug)
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 378 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
时间窗: Up to approximately 364 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
次要结局
- Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score(Week 364)
- Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score(Week 364)
- Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD)(Week 364)
- Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission Per Modified Mayo Score (MMS)(Week 364)