An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Crohn's Disease Investigational Medication Study
Study Overview
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:
The study duration may be up to 35 weeks with:
- Up to 5-week 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).
- 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.
The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Crohn's Disease
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Age: 16 years - 80 years
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Gender: All
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 Crohn's Disease (CD) for at least 3 months prior to baseline
Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)
Exclusion Criteria:
Participants with Ulcerative Colitis (UC) or indeterminate colitis
Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
Prior or current high-grade gastrointestinal (GI) dysplasia
Participants on treatment with but not on stable doses of conventional therapy prior to baseline
Participants receiving prohibited medications or therapies
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.
This study investigates the effects of an investigational medication on people with moderately to severely active Crohn's Disease (CD). Crohn's Disease is a chronic inflammatory condition of the gastrointestinal tract that can cause a range of symptoms, including abdominal pain, diarrhea, and weight loss. The purpose is to evaluate how well the investigational medication works and how safe it is for people with CD.
Participants will be randomly assigned to different study arms, including a placebo arm, to compare outcomes. Some participants may receive an inactive substance that looks like the investigational medication but does not contain any medicine, known as a placebo. The study involves multiple sub-studies, each lasting up to 12 weeks, with a follow-up period for those not continuing to additional phases.
- Who can participate: Participants aged 18 to 80 years, or 16 to 18 years with Tanner Stage 5 development, with a confirmed diagnosis of moderately to severely active Crohn's Disease for at least 3 months may join. They must have shown inadequate response to other therapies.
- Study details: Participants will be assigned to different study arms, including a placebo arm. They will receive either the investigational medication or a placebo.
- Study timelines and visits: The study will last up to 35 weeks. The study requires up to 8 visits for Sub-Study 1 and Sub-Study 2, and up to 15 visits for Sub-Study 3.
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