Recruiting NCT07184996

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Phase III Interventional Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Duvakitug, Placebo.
Who it may be relevant to: Registry conditions: Ulcerative Colitis. Basic parameters: 16 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Bulgaria, Canada, China, Czechia +15
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

Drug Duvakitug
Pharmaceutical form:Solution for Injection-Route of administration:SC injection
Drug Placebo
Pharmaceutical form:Solution for injection-Route of administration:SC injection

Primary outcome measures

Proportion of participants achieving clinical remission. [Time frame: Week 12]

Secondary outcome measures (12)

Proportion of participants who achieve endoscopic improvement. [Time frame: Week 12]
Proportion of participants achieving clinical response by modified Mayo Score (mMS). [Time frame: Week 12]
Proportion of participants achieving histological endoscopic mucosal improvement. [Time frame: Week 12]
Change from baseline in PROMIS-Fatigue Short Form 7a T-score. [Time frame: Baseline, Week 12]
Proportion of participants with symptomatic (SFS and RBS) remission [Time frame: Week 12]
Proportion of participants with no bowel urgency. [Time frame: Week 12]
Proportion of participants reporting no nocturnal bowel movements. [Time frame: Week 12]
Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission. [Time frame: Week 4]
Proportion of participants who achieve endoscopic remission. [Time frame: Week 12]
Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS). [Time frame: Week 12]
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score. [Time frame: Baseline, Week 12]
Proportion of participants with UC-related hospitalization. [Time frame: Baseline through Week 12]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment