A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Investigation of an Investigational Medication for Crohn's Disease
Study Overview
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include:
The study duration may be up to 286 weeks including:
- 40-week Pivotal Maintenance Sub-Study
- 240-week Open-Label Extension (OLE) Sub-Study
- 45-day Follow-Up visit
Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.
The treatment duration may be up to 280 weeks including:
- 40 weeks in the Pivotal Maintenance Sub-Study
- 240 weeks in OLE Sub-Study
The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study
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 Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development) Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1 OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study
Exclusion Criteria:
Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator 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 use of an investigational medication in people with moderately to severely active Crohn's Disease. Crohn's Disease is a chronic inflammatory condition of the gastrointestinal tract, which can cause symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The purpose of this study is to evaluate the effectiveness and safety of the investigational medication in maintaining disease control.
Participants in the study will be randomly assigned to receive either the investigational medication or a placebo, which 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 will know who is receiving the actual medication or the placebo. The study includes a Pivotal Maintenance Sub-Study and an Open-Label Extension Sub-Study.
- Who can participate: Adults aged 18 to 80 years, or those 16 to 18 years at Tanner stage 5, may participate. Key eligibility includes achieving clinical response and completing endoscopy in a prior study.
- Study details: Participants will either receive the investigational medication or a placebo. The study is double-blind and includes a maintenance and an open-label extension phase.
- Study timelines and visits: The study will last 286 weeks. The study requires 43 visits.
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