Actively Recruiting
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate SAR442970 in Adults With Moderate to Severe Crohns Disease
Led by Sanofi · Updated on 2026-03-27
99
Participants Needed
66
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SAR442970, a drug given by injection under the skin, for adults with moderate to severe Crohns disease. This phase 2b, randomized, double-blind study compares two different doses of SAR442970 with placebo to understand its effects on the condition. The study aims to measure how many participants achieve an endoscopic response by Week 16, among other clinical improvements. Participants are randomly assigned to receive one of three treatments SAR442970 dose regimen A, SAR442970 dose regimen B, or placebo. Treatments are given subcutaneously, and the study includes a treatment period lasting up to 158 weeks. There is also an open-label long-term extension phase lasting up to 104 weeks for those who qualify, allowing continued evaluation of SAR442970s effects over time. During the study, participants will undergo assessments including endoscopic exams, clinical remission evaluations using the Crohns Disease Activity Index CDAI, patient-reported outcomes, and quality-of-life questionnaires. Safety is monitored by tracking adverse events and measuring drug levels in the blood. The total participation time can be up to 168 weeks, with ongoing evaluations to assess both short- and long-term outcomes.
CONDITIONS
Brief Title
A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Crohn's Disease for at least 3 months prior to screening
- Confirmed moderate-to-severe Crohn's Disease
- History of prior exposure to standard treatments or advanced therapies with inadequate response, loss of response, or intolerance
- On stable doses of standard treatments prior to screening
- Use of contraception consistent with local regulations for men and women participating in clinical studies
You will not qualify if you...
- Active ulcerative colitis, indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia, or short bowel syndrome
- Crohn's Disease isolated to stomach, duodenum, jejunum, or perianal region without colonic or ileal involvement
- Ongoing complications such as conditions requiring bowel surgery, ostomy or ileoanal pouch
- Surgical bowel resection within 3 months prior to screening or history of more than 3 bowel resections
- Any condition that may put the participant at risk as judged by the Investigator
- Conditions interfering with drug absorption including short bowel syndrome
- History of other significant medical conditions per Investigator's opinion that risk participation in the study
Research Team
T
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