A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 39
- 主要终点
- Serious Adverse Events
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of tulisokibart (MK-7240) in participants with moderately to severely active Crohn's Disease.
After the completion of the 12-week Induction Period, eligible participants have the option to enter an Open-label Extension (OLE) Period for up to 170 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Crohn's disease (CD)
- •Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy
- •Must have corticosteroid dependence or have had no response, insufficient response, loss of response and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF), anti-integrin, or anti-interleukin (IL)12/23
- •Able to provide written informed consent and understand and comply with the requirements of the study
排除标准
- •Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug
- •Diagnosis of ulcerative colitis (UC) or indeterminate colitis
- •CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement
- •Suspected or diagnosed intra-abdominal or perianal abscess at screening
- •Current stoma or need for colostomy or ileostomy
- •Previous small bowel resection with a combined resected length of >100 cm or previous colonic resection of > 2 segments
- •Surgical bowel resection within 3 months before screening
- •Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
- •Participants in the opinion of the investigator are at an unacceptable risk for participation in the study
- •Participants who meet the protocol criteria for important laboratory exclusion criteria
研究组 & 干预措施
Induction Tulisokibart
During the 12-week Induction Period, participants receive tulisokibart administered by intravenous (IV) infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10.
干预措施: Companion Diagnostic (CDx) (Diagnostic Test)
Induction Tulisokibart
During the 12-week Induction Period, participants receive tulisokibart administered by intravenous (IV) infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10.
干预措施: Tulisokibart (Biological)
OLE Tulisokibart 100 mg
After completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 100 mg tulisokibart by IV infusion every 4 weeks (q4w). At the discretion of the investigator, participants may titrate up to 250 mg Q4W if disease activity is not adequately controlled.
干预措施: Tulisokibart (Biological)
OLE Tulisokibart 250 mg
After completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 250 mg tulisokibart by IV infusion q4w.
干预措施: Tulisokibart (Biological)
结局指标
主要结局
Serious Adverse Events
时间窗: Week 12
Number of participants who experienced serious adverse events (SAEs)
Adverse Events Leading to Discontinuation
时间窗: Week 12
Number of participants who experienced AEs leading to discontinuation
Adverse Events
时间窗: Week 12
Number of participants who experienced treatment-emergent adverse events (AEs)
Endoscopic Improvement
时间窗: Week 12
Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease \[SES-CD\] ≥ 50% from Baseline)
Adverse Events
时间窗: Up to approximately 18 weeks
Number of participants who experienced treatment-emergent adverse events (AEs)
Serious Adverse Events
时间窗: Up to approximately 18 weeks
Number of participants who experienced serious adverse events (SAEs)
Adverse Events Leading to Discontinuation
时间窗: Up to approximately 12 weeks
Number of participants who experienced AEs leading to discontinuation
次要结局
- Endoscopic and Clinical Improvement(Week 12)
- Clinical Remission(Week 12)
- Normalization of C-reactive Protein(Week 12)
- Normalization of Fecal Calprotectin(Week 12)
- Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)(Baseline and Week 12)
- Serum Concentration of PRA023 (MK-7240)(Week 12)
- Number of Participants Achieving a Composite Response(Week 12)
- Clinical Response(Week 12)
- Number of Participants With Positive Neutralizing Anti-Bodies (NAB)(Up to approximately 12 weeks)
- Two Component Patient-reported Outcome (PRO-2) Remission(Week 12)
- Number of Participants Positive for Anti-drug Antibody (ADA)(Up to approximately 12 weeks)
- Number of Participants Achieving Biomarker and Clinical Composite Improvement(Week 12)
- Serum Concentration of Tulisokibart(Week 12)