A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 148
- 试验地点
- 32
- 主要终点
- Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn’s Disease Activity Index (CDAI) at Week 12
研究概览
简要总结
Sub-Study 2: To assess the efficacy of duvakitug as induction therapy in participants with moderately to severely active CD compared with placebo.
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 0-17 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development
- •Confirmed diagnosis of moderately to severely active Crohn’s Disease (CD) for at least 3 months prior to baseline
- •Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)
排除标准
- •Participants with Ulcerative Colitis (UC) or indeterminate colitis
- •Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
- •Prior or current high-grade gastrointestinal (GI) dysplasia
- •Participants on treatment with but not on stable doses of conventional therapy prior to baseline
- •Participants receiving prohibited medications or therapies
- •Participants with previous exposure to anti-TL1A investigational therapy
结局指标
主要结局
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn’s Disease Activity Index (CDAI) at Week 12
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn’s Disease Activity Index (CDAI) at Week 12
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn's Disease [SES-CD]) at Week 12
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn's Disease [SES-CD]) at Week 12
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12
次要结局
- Sub-Study 2: Proportion of participants achieving CDAI clinical response at Week 12
- Sub-study 2: Proportion of participants achieving CDAI clinical response and endoscopic response (SES-CD) at Week 12
- Sub-study 2: Proportion of participants achieving endoscopic SES- CD remission at Week 12
- Sub-study 2: US/FDA: Proportion of participants achieving clinical remission per PRO-2 at Week 12
- Sub-study 2: EU/EMA: Proportion of participants achieving clinical remission per CDAI at Week 12
- Sub-study 2: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at baseline) at Week 12
- Sub-study 2: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a T-score at Week 12
- Sub-study 2: Proportion of participants achieving CDAI clinical response at Week 4
- Sub-study 2: US/FDA: Proportion of participants achieving corticosteroid free remission (in the subset of participants with corticosteroids at baseline) per CDAI at Week 12
- Sub-study 2: EU/EMA: Proportion of participants achieving corticosteroid free remission per PRO-2 (in the subset of participants with corticosteroids at baseline) at Week 12
- Sub-study 2: Proportion of participants achieving CDAI clinical remission and endoscopic remission (SES-CD) at Week 12
- Sub-study 2: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 12
- Sub-study 2: Proportion of participants with no bowel urgency by Numeric Rating Scale (NRS) at Week 12
- Sub-study 2: Proportion of participants with CD-related hospitalizations by Week 12
- Sub-study 2: Number of participants with any Treatment Emergent Adverse Events (TEAEs), treatment-emergent adverse event of special interest (TEAESIs), treatment-emergent serious adverse event (TESAEs), and TEAEs leading to permanent study intervention discontinuation
- Sub-study 2: Serum concentrations of duvakitug
- Sub-study 2: Incidence of treatment-emergent Anti-drug Antibodies (ADA) against duvakitug
研究者
Clinical Services and operations
Scientific
Sanofi-Aventis Recherche & Developpement