NCT07185009招募中3 期
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 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
- 751
- 试验地点
- 55
- 主要终点
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance 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 286 weeks including:
- 40-week Pivotal Maintenance Sub-Study
- 240-week Open-Label Extension (OLE) Sub-Study
- 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.
The treatment duration may be up to 280 weeks including:
- 40 weeks in Pivotal Maintenance Sub-Study
- 240 weeks in OLE Sub-Study
The total number of on-site visit will be up to 32:
- 21 visits in the Pivotal Maintenance Sub-Study.
- 11 visits in the OLE Sub-Study.
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 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 SUNSCAPE-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
- •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)
Placebo
Placebo Comparator
SC injection as per protocol
干预措施: Placebo (Drug)
Duvakitug - dose 3
Experimental
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)
结局指标
主要结局
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).
时间窗: Week 40
Mayo Score is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity. Clinical remission is defined as mMS score of 0 to 2, including SFS of 0 or 1, RBS of 0, and mMES of 0 or 1 (score of 1 modified to exclude friability)
次要结局
- Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score.(Baseline, Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic remission.(Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic improvement.(Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving histologic endoscopic mucosal improvement.(Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission.(Week 40)
- Proportion of participants with no bowel urgency.(Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by mMS, in the subset of participants who achieved clinical remission by mMs at the end of induction period (maintenance of clinical remission).(Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no abdominal pain by Numerical Rating Scale (NRS).(Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score(Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Incidence of UC-related hospitalizations.(Week 0 through Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.(Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission and no steroid use from the baseline to the time of endpoint analysis.(Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Incidence of Treatment-Emergent Adverse Events (TEAEs), TEAEs of Special Interest, Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading to permanent study intervention discontinuation.(Week 0 through 45 days after last dose)
- Pivotal Maintenance Sub-Study Cohort 1: Serum concentration of duvakitug measured over time.(Week 0 through Week 40)
- Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.(Week 0 through Week 40)
- Open-Label Extension Sub-Study: Incidence of Treatment-Emergent Adverse Events (TEAEs), TEAEs of Special Interest, Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading to permanent study intervention discontinuation.(Week 40 of pivotal maintenance through 45 days after last dose)
研究者
研究点 (55)
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