Actively Recruiting
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate SAR442970 in Adults With Moderate to Severe Ulcerative Colitis Including a Long-term Extension
Led by Sanofi · Updated on 2026-04-23
99
Participants Needed
67
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness and safety of SAR442970 in adults with moderate to severe Ulcerative Colitis in a phase 2b randomized, double-blind study. The trial compares two different doses of SAR442970 against a placebo to see how well they work in treating this condition. The total study duration can last up to 168 weeks, including a long-term extension period for eligible participants. Participants will be randomly assigned to receive one of three treatments SAR442970 dose regimen A, SAR442970 dose regimen B, or a matching placebo, all given by subcutaneous injection. The study includes a treatment period lasting up to 158 weeks, followed by an open-label long-term extension phase of up to 104 weeks for those who qualify. Throughout the study, participants will undergo regular assessments to measure clinical remission using the modified Mayo Score at Week 16, as well as other outcomes such as endoscopic improvement, histological remission, and patient-reported outcomes. Safety will be monitored by tracking adverse events. Blood samples for drug concentration and antibodies will also be collected. The overall participation may last up to approximately 164 weeks.
CONDITIONS
Brief Title
A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 75 years inclusive at the time of signing informed consent
- Clinical evidence of active Ulcerative Colitis for at least 3 months before screening confirmed by endoscopy
- Active moderate-to-severe Ulcerative Colitis at screening defined by modified Mayo Score of 5 to 9, with specific subscore requirements and disease extent of at least 15 cm from the anal verge
- Prior treatment with standard therapies such as amino-salicylates, corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine with inadequate response, intolerance, or corticosteroid dependence without prior exposure to advanced therapies
- Or prior treatment with at least one approved advanced therapy such as biologic agents or advanced small molecules with inadequate response, intolerance, or loss of response
- Consistent contraceptive use by men and women according to local regulations during the study
You will not qualify if you...
- Active Crohn's Disease, indeterminate colitis, or microscopic colitis
- Positive stool test for aerobic pathogens or Clostridium difficile B toxin
- Presence of ostomy, ileoanal pouch, prior or anticipated colectomy during study
- Ongoing complications such as fulminant disease, toxic megacolon, or colonic dysplasia except adenoma
- Intestinal failure or short bowel syndrome requiring total parenteral nutrition
- Recent serious infection requiring hospitalization or IV/oral anti-infective treatment within specified timeframes
- Known significant current immunosuppression
- History of solid organ transplant or splenectomy
- History of moderate to severe congestive heart failure or recent cerebrovascular accident
- History of demyelinating disease or related neurological symptoms
- History of malignancy or lymphoproliferative disease except certain treated localized skin or cervical cancers
- Diagnosis of other inflammatory conditions such as lupus, rheumatoid arthritis, multiple sclerosis, or sarcoidosis
- History of HIV infection or positive HIV serology at screening
- History of interstitial lung disease
- Positive hepatitis B or C markers at screening
- Abnormal screening laboratory or other analyses
- Any other condition deemed by the investigator to pose risk by participation
Research Team
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