An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Study on the Efficacy and Safety of an Investigational Medication for Active 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 (CD). The study is divided into three sub-studies to evaluate how well the medication works and how safe it is for participants.
Participants in the study may undergo several procedures, including randomization to different study arms, where some may receive the investigational medication and others a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication, which helps ensure unbiased results.
- Who can participate: Participants aged 18 to 80 years old, or 16 to under 18 if they meet certain development criteria, can join. They must have moderately to severely active Crohn's Disease and have not responded well to previous treatments. Certain medical conditions and treatments may exclude individuals.
- Study details: Participants will be randomly assigned to different study arms, including an arm receiving a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. They will follow a set protocol of medication administration and monitoring to assess the investigational medication's effects.
- Study timelines: The study will last up to 35 weeks.
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