NCT07184996招募中3 期
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 Ulcerative Colitis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 980
- 试验地点
- 223
- 主要终点
- Proportion of participants achieving clinical remission.
研究概览
简要总结
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include:
The study duration may be up to 35 weeks with:
- Screening period
- 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction)
- 12-week Sub-Study 3 (Extended Induction for non-responders)
- 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)
The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 UC for at least 3 months prior to Baseline
- •Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies
排除标准
- •Participants with Crohn's Disease (CD), indeterminate colitis
- •Current diagnosis of Ulcerative Proctitis
- •Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections
- •Prior or current high-grade gastrointestinal (GI) dysplasia
- •Participants on treatment with but not on stable doses of conventional therapies prior to baseline
- •Participants with prohibited medications or therapies prior to baseline
- •Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Duvakitug - dose 1
Experimental
Subcutaneous (SC) injection as per protocol
干预措施: Duvakitug (Drug)
Duvakitug - dose 2
Experimental
SC injection as per protocol
干预措施: Duvakitug (Drug)
Placebo
Placebo Comparator
SC injection as per protocol
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants achieving clinical remission.
时间窗: Week 12
Clinical remission is defined as modified Mayo Score (mMS) score of 0 to 2, including SFS of 0 or 1, RBS of 0, and modified Mayo Endoscopic Score (MES) of 0 or 1 (score of 1 modified to exclude friability). mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.
次要结局
- Proportion of participants achieving histological endoscopic mucosal improvement.(Week 12)
- Change from baseline in PROMIS-Fatigue Short Form 7a T-score.(Baseline, Week 12)
- Proportion of participants with symptomatic (SFS and RBS) remission(Week 12)
- Proportion of participants achieving clinical response by modified Mayo Score (mMS).(Week 12)
- Proportion of participants with no bowel urgency.(Week 12)
- Proportion of participants reporting no nocturnal bowel movements.(Week 12)
- Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.(Week 4)
- Proportion of participants who achieve endoscopic remission.(Week 12)
- Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS).(Week 12)
- Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.(Baseline, Week 12)
- Proportion of participants with UC-related hospitalization.(Baseline through Week 12)
- Proportion of participants achieving clinical remission and no steroid use.(Week 12)
- 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.(Baseline through 45 days after last dose)
- Serum concentration of duvakitug measured over time.(Baseline through Week 12)
- Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.(Baseline through Week 12)
- Proportion of participants who achieve endoscopic improvement.(Week 12)
- Change from baseline in PROMIS-Fatigue Short Form 7a T-score.(Baseline, Week 12)
- Proportion of participants with no bowel urgency.(Week 12)
- Proportion of participants achieving clinical response by modified Mayo Score (mMS).(Week 12)
- Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.(Week 4)
- Proportion of participants who achieve endoscopic remission.(Week 12)
- Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS).(Week 12)
- Proportion of participants achieving histological endoscopic mucosal improvement.(Week 12)
- Proportion of participants with symptomatic (SFS and RBS) remission(Week 12)
- Proportion of participants reporting no nocturnal bowel movements.(Week 12)
- Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.(Baseline, Week 12)
- Proportion of participants with UC-related hospitalization.(Baseline through Week 12)
- Proportion of participants achieving clinical remission and no steroid use.(Week 12)
- 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.(Baseline through 45 days after last dose)
- Serum concentration of duvakitug measured over time.(Baseline through Week 12)
- Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.(Baseline through Week 12)
研究者
研究点 (223)
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