A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Colitis Ulcerative

In brief

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis. This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study). * The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.

Key facts

Study ID

NCT06867094

Run by

Sanofi

People needed

204

Starts

2025-03-28

Expected to finish

2028-05-11

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
• 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 (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent >15 cm from the anal verge
• Must have received prior treatment for UC (either "a" or "b" below or a combination of both "a" and "b"):
• History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR
• History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for UC
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis
• Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study
• Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study
• Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools
• Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines
• Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and/or hepatitis C virus antibody (HCVAb) at the screening visit
• Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
• Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
• Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
• History of gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit.
• If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
• Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug
• Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit or oral/intramuscular anti-infectives within 14 days prior to the screening visit
• Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
• Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
• Participants who received fecal microbial transplantation within 30 days prior to screening
• Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
• Participants who received IV corticosteroids within 14 days prior to screening or during screening period
• Screening laboratory and other analyses show abnormal results.
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Bristol Hospital- Site Number : 8400017 — Bristol, Connecticut, United States (enrolling)
• Novum Research- Site Number : 8400018 — Clermont, Florida, United States (enrolling)
• Clinical Research of Osceola- Site Number : 8400012 — Kissimmee, Florida, United States (enrolling)
• Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002 — Miami Lakes, Florida, United States (enrolling)
• GCP Clinical Research- Site Number : 8400016 — Tampa, Florida, United States (enrolling)
• GI Alliance - Glenview- Site Number : 8400005 — Glenview, Illinois, United States (enrolling)
• Illinois Gastroenterology Group- Site Number : 8400004 — Gurnee, Illinois, United States (enrolling)
• University of Michigan Health System - Ann Arbor- Site Number : 8400010 — Ann Arbor, Michigan, United States (enrolling)
• Icahn School of Medicine at Mount Sinai- Site Number : 8400001 — New York, New York, United States (enrolling)
• Queens Village Primary Medical Center- Site Number : 8400011 — Queens Village, New York, United States (enrolling)
• NexGen Research- Site Number : 8400020 — Lima, Ohio, United States (enrolling)
• Frontier Clinical Research - Uniontown- Site Number : 8400006 — Uniontown, Pennsylvania, United States (enrolling)
• Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008 — Charleston, South Carolina, United States (enrolling)
• Gastro Health & Nutrition- Site Number : 8400007 — Katy, Texas, United States (enrolling)
• SI Research Associates- Site Number : 8400019 — Lubbock, Texas, United States (enrolling)
• Texas Digestive Disease Consultants - Southlake- Site Number : 8400015 — Southlake, Texas, United States (enrolling)
• University of Washington Medical Center- Site Number : 8400014 — Seattle, Washington, United States (enrolling)
• Washington Gastroenterology - Tacoma- Site Number : 8400009 — Tacoma, Washington, United States (enrolling)
• Investigational Site Number : 0320004 — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• Investigational Site Number : 0320003 — Buenos Aires, Argentina (enrolling)
• Investigational Site Number : 0320002 — Buenos Aires, Argentina (enrolling)
• Investigational Site Number : 0320001 — Buenos Aires, Argentina (enrolling)
• Investigational Site Number : 0320005 — Buenos Aires, Argentina (enrolling)
• Investigational Site Number : 0360003 — Kurralta Park, South Australia, Australia (enrolling)
• GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003 — Sun City, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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