An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Investigational Medication Study 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 individuals with moderately to severely active Crohn's Disease (CD). The purpose of this study is to understand how the investigational medication can affect the symptoms and progression of CD.
The study involves several procedures, including randomization, which means participants will be assigned to different study arms by chance. It is a double-blind study, meaning neither the participants nor the researchers know who is receiving the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants will undergo various assessments to monitor their health and the effects of the treatment.
- Who can participate: Adults aged 18 to 80 years with moderately to severely active Crohn's Disease can participate. Individuals aged 16 to 18 may also join if they meet specific developmental criteria. Key eligibility includes having an inadequate response to previous therapies.
- Study details: Participants will be randomly assigned to different study arms, and some will receive a placebo. They will be monitored through various health assessments to evaluate their response to the treatment.
- Study timelines: The study will last up to 35 weeks.
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