2025-521035-37-00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.
Sanofi-Aventis Recherche & Developpement19 个研究点 分布在 2 个国家目标入组 55 人开始时间: 2026年2月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 19
- 主要终点
- Proportion of participants achieving clinical remission.
研究概览
简要总结
To assess the efficacy of duvakitug as induction therapy in the treatment of moderately to severely active UC compared to 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 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
结局指标
主要结局
Proportion of participants achieving clinical remission.
Proportion of participants achieving clinical remission.
次要结局
- Proportion of participants who achieve endoscopic improvement.
- Proportion of participants achieving clinical response by modified Mayo Score (mMS).
- Proportion of participants achieving histological endoscopic mucosal improvement.
- Change from baseline in PROMIS-Fatigue Short Form 7a T-score.
- Proportion of participants with symptomatic (SFS and RBS) remission
- Proportion of participants with no bowel urgency
- Proportion of participants reporting no nocturnal bowel movements
- Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.
- Proportion of participants who achieve endoscopic remission.
- Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS).
- Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.
- Proportion of participants with UC-related hospitalization
- Proportion of participants achieving clinical remission and no steroid use.
- Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment- Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-Emergent Adverse Events (TEAEs) leading to permanent study intervention discontinuation.
- Serum concentration of duvakitug measured over time.
- Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (19)
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