An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Research Study on Investigational Medication for Crohn's Disease
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 efficacy and safety of an investigational medication in people with moderately to severely active Crohn's Disease. Participants will be part of a study lasting up to 35 weeks. This includes a screening period of up to 5 weeks, followed by a treatment duration of up to 12 weeks in each sub-study, and a follow-up period of 6 weeks for those not continuing to a maintenance study.
Participants will undergo various study procedures, including randomized and placebo-controlled phases. In some parts of the study, participants will not know if they are receiving the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
- Who can participate: Participants aged 16 to 80 years with moderately to severely active Crohn's Disease for at least 3 months can join if they have shown inadequate response or intolerance to conventional or advanced therapies. Exclusions include those with Ulcerative Colitis or missing segments of certain intestines.
- Study details: Participants will be randomly assigned to different study arms and may receive either the investigational medication or a placebo. They will follow the study procedures as outlined, which include regular check-ups and monitoring.
- Study timelines: The study will last up to 35 weeks.
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