A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, maintenance 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
- 53
- 试验地点
- 32
- 主要终点
- Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
研究概览
简要总结
Pivotal Maintenance Sub-Study Cohort 1: To assess the efficacy of duvakitug as maintenance therapy compared with placebo in participants with moderately to severely active CD
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 Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)
- •Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1
- •OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study
排除标准
- •Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
- •Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator
结局指标
主要结局
Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving clinical remission per PRO-2 at Week 40
Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving clinical remission per PRO-2 at Week 40
Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving clinical remission (CDAI) at Week 40
Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving clinical remission (CDAI) at Week 40
次要结局
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40
- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40
- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40
- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40
- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40
- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40
- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at Baseline) at Week 40
- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per CDAI at Week 40 in the subset of participants with clinical remission per CDAI at Week 0 (maintenance of clinical remission per CDAI)
- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per PRO-2 at Week 40 in the subset of participants with clinical remission per PRO-2 at Week 0 (maintenance of clinical remission per PRO-2)
- Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score at Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in IBDQ total score at Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no bowel urgency by NRS at Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Incidence of CD related hospitalization by Week 40
- Pivotal Maintenance Sub-Study Cohort 1: Serum concentrations of duvakitug measured over time
- Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment- emergent antidrug antibody (ADA) against duvakitug
- Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment- emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (TEAESIs), treatment-emergent serious adverse events (TESAEs) and TEAEs leading to permanent study intervention discontinuation
- Open-Label Extension Sub-Study: Incidence of TEAEs, TEAESIs, TESAEs, and TEAEs leading to permanent study intervention discontinuation
研究者
Clinical Services and operations
Scientific
Sanofi-Aventis Recherche & Developpement