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SAR441566 in Adults With Moderate-to-severe Ulcerative Colitis
NCT06867094Phase 2
Key facts
- Status
- Terminated
- Start
- Mar 2025
- Primary completion
- Aug 2026
- Countries
- 24
- Sponsor
- Sanofi
- Modality
- Small Molecules
- Drugs
- balinatunfib
- Conditions
- ulcerative colitis (UC)
01
Overview
Phase 2, randomised, double-blind trial of balinatunfib in ulcerative colitis (UC) (4 arms), sponsored by Sanofi. Primary endpoint: Proportion of participants achieving clinical remission by modified Mayo Score (mMS) at 12 weeks. Started Mar 2025; status: terminated.
02
Design
4 arms- Study design
- RandomizedDouble-blind
SAR441566 dose regimen 1
Participants will receive SAR441566 dose regimen 1
SAR441566 dose regimen 2
Participants will receive SAR441566 dose regimen 2
SAR441566 dose regimen 3
Participants will receive SAR441566 dose regimen 3
Placebo
Participants will receive SAR441566-matching placebo
03
Who it enrols
Adults with active moderate-to-severe ulcerative colitis who have had an inadequate response, loss of response, or intolerance to standard treatments or advanced therapies.
04
Endpoints
Primary
Proportion of participants achieving clinical remission by modified Mayo Score (mMS)
Secondary
Proportion of participants achieving clinical response by modified Mayo Score (mMS)
Proportion of participants achieving clinical response by full Mayo score (MS)
Proportion of participants achieving clinical remission by full Mayo score (MS)
Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission
Proportion of participants achieving endoscopic remission
Change from baseline in PRO2
Proportion of participants achieving endoscopic response
Proportion of participants achieving endoscopic improvement
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