A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR442970 in Adults With Moderate to Severe Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 99
- 试验地点
- 104
- 主要终点
- Percentage of participants who achieve endoscopic response at Week 16
研究概览
简要总结
This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening
- •Confirmed diagnosis of moderate-to-severe CD
- •History of prior exposure to standard treatment (5-Amino Salicylates (5-ASAs), steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies
- •On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, Azathioprine (AZA), 6-Mercaptopurine (6-MP), or Methotrexate (MTX), or Antibiotics, etc.)
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
排除标准
- •Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome
- •Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
- •Participants with following ongoing known complications of CD:
- •Any manifestation that might require bowel surgery while enrolled in the study
- •Participant with ostomy or ileoanal pouch
- •Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome
- •Participant with surgical bowel resection within the past three months prior to screening, or a history of >3 bowel resections
- •History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
SAR442970 Dose Regimen A
Participants will receive SAR442970 dose regimen A
干预措施: SAR442970 (Drug)
SAR442970 Dose Regimen B
Participants will receive SAR442970 dose regimen B
干预措施: SAR442970 (Drug)
Placebo
Participants will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of participants who achieve endoscopic response at Week 16
时间窗: From Baseline to Week 16
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) \>50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
次要结局
- On-treatment serum concentrations of SAR442970 at predefined timepoints(Up to End of Study (approximately 164 weeks))
- Number and percentage of participants with any Treatment Emergent Adverse Events (TEAEs) during induction, maintenance and Long-term Extension (LTE) treatment period(Up to End of Study (approximately 164 weeks))
- Number and percentage of participants with any TEAEs during open-label treatment period(Up to Week 52)
- Incidence of Anti-drug Antibodies (ADAs) over time(Up to End of Study (approximately 164 weeks))
- Percentage of participants who achieve clinical remission based on Crohn's Disease Activity Index (CDAI) at Week 16(At Week 16)
- Percentage of participants who achieve PRO-2 (Patient Reported Outcome) clinical remission at Week 16(At Week 16)
- Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 16(At Week 16)
- Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 16(At Week 16)
- Percentage of participants who achieve CDAI clinical response at Week 16(At Week 16)
- Change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) score(From Baseline to Week 16)
- Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score(From Baseline to Week 16)
- Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 52(At Week 52)
- Percentage of participants achieving CDAI clinical remission at Week 52(At Week 52)
- Percentage of participants achieving CDAI clinical remission at both Week 16 and at Week 52(At Week 52)
- Percentage of participants who achieve endoscopic response at Week 52(At Week 52)
- Percentage of participants who achieve endoscopic response at both Week 16 and Week 52(At Week 52)
- Percentage of participants who achieve CDAI clinical response at Week 52(At Week 52)
- Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 52(At Week 52)