Crohn’s Disease: SAR441566 Study – Study Partner
A study to investigate the efficacy and safety of SAR441566 in patients with Crohn’s disease (SPECIFI-CD)
ClinicalTrials.gov ID: NCT06637631
Sponsor: Sanofi (Information provided by Sanofi (responsible party))
Study overview
Official title: A multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 2 dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn’s disease.
Brief summary
This is a Phase 2 study that is multinational, multicenter, randomized, double-blind, placebo-controlled, and dose-ranging to investigate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn’s disease (CD).
The primary objective of this study is to evaluate the efficacy of different dosages of SAR441566 compared to placebo in participants with moderate to severe Crohn’s disease.
The estimated total duration of the study is up to 59 weeks. This includes:
- a screening phase of 4 weeks (plus up to 7 calendar days if required),
- followed by the main study treatment phase lasting 52 weeks,
- as well as a 2-week follow-up phase after the end of treatment.
The main study phase includes a double-blind treatment phase with 12 weeks of induction, followed by 40 weeks of maintenance therapy.
In addition, eligible participants will be offered an open-label treatment phase of up to 40 weeks. The combined duration of the double-blind maintenance phase and the open-label treatment phase must not exceed 40 weeks in total, depending on when the participants switch.
