A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
Part of paid clinical trials in Sun City, Arizona.
- Sponsor
- Sanofi
- Study ID
- NCT06637631
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- SAR441566 — DRUGPharmaceutical form: Tablet Route of administration: Oral
- SAR441566 matching Placebo — DRUGPharmaceutical form: Tablet Route of administration: Oral
Study Details
This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD. This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.
Key Dates
- Start date
- Dec 10, 2024
- Status verified
- May 2026
- Primary completion
- Jul 21, 2027
- Completion
- May 23, 2029
Study Design
- Enrollment
- 260 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SAR441566 dose 1Participants will receive SAR441566 dose 1.
- Experimental: SAR441566 dose 2Participants will receive SAR441566 dose 2.
- Experimental: SAR441566 dose 3Participants will receive SAR441566 dose 3.
- Placebo Comparator: PlaceboParticipants will receive SAR441566 matching placebo.
Primary Outcome Measure
Proportion of participants achieving endoscopic response [ Time Frame: Week 12 ]
Central Contacts
- Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
Locations (19)
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