DRI18450
Research type
Research Study
Full title
A Phase 2, multicenter, randomized, double-blind, placebo controlled, dose-ranging study to evaluate the efficacy and safety of SAR442970 in adults with moderate to severe Crohn’s disease
IRAS ID
1011771
Contact name
Global Regulatory Submissions
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Research summary
Crohn's disease (CD) is a chronic inflammation condition of the bowel that primarily affects the digestive tract, causing symptoms like abdominal pain (pain in the belly), loose stools, and tiredness.
This study will assess how well participants with CD, aged 18 to 75 years, respond to different doses of SAR442970 compared with placebo. This will be measured by the percentage of participants who after 16 weeks on treatment show reduction of the disease activity in colonoscopy by 50% or more. Side effects of SAR442970 will also be assessed.
This study is a double-blind, randomized, placebo controlled, 3-arm study where each person with CD participates for up to 168 weeks, including the following periods:
- A screening period up to 4 weeks to determine participant suitability to start study treatment.
- A double-blind (DB) treatment period up to 52 weeks, with 16 weeks of DB induction period followed by 36 weeks of maintenance period. “DB” means that neither the people taking part nor the study doctors know who is given the study medicine or the placebo. In case a participant's symptoms worsen during DB maintenance period, the participant may be eligible to switch to an open label (OL) treatment option with SAR442970 up to 36 weeks. “OL” means that the participants and researchers both know which treatment is given.
- An OL long-term extension (LTE) treatment period offered after the end of 52 weeks treatment up to 104 weeks.
- An 8-week follow-up period after treatment is permanently stopped for any reason.
Each participant receives injections under the skin every 2 weeks 1 of the 2 possible dose regimens of SAR442970, or placebo during DB period, and the highest dose of SAR442970 every 2 weeks during OL treatment option or OL LTE period.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0133
Date of REC Opinion
30 May 2025
REC opinion
Further Information Favourable Opinion