A Phase 2b, Multi-national, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Followed by a Long-term Extension to Evaluate the Efficacy and Safety of SAR442970 in Adult Participants With Moderate to Severe Ulcerative Colitis
Sanofi
Summary
This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Ulcerative Colitis. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Ulcerative Colitis. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent * Participants who have had clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period * Must have active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician Global Assessment (PGA), with a minimum Rectal Bleeding (RB) subscore ≥1, a minimum Stool Frequency…
Interventions
- DrugSAR442970
Route of administration: Subcutaneous
- DrugPlacebo
Route of administration: Subcutaneous
Locations (67)
- Investigational Site Number: 8400009Escondido, California
- Investigational Site Number: 8400006Lancaster, California
- Investigational Site Number: 8400025Thousand Oaks, California
- Investigational Site Number: 8400024Jacksonville, Florida
- Investigational Site Number: 8400030Kissimmee, Florida
- Investigational Site Number: 8400003Lighthouse PT, Florida