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A Study of SAR441566 for Moderate-to-Severe Ulcerative Colitis

This study is testing a new oral medication called SAR441566 for adults with moderate-to-severe ulcerative colitis (UC), a chronic inflammatory bowel disease. Researchers want to see how well SAR441566 works and if it is safe compared to a placebo (an inactive pill that looks like the study drug). The main goal is to see how many participants achieve clinical remission (a period where symptoms are greatly reduced or absent) after 12 weeks. You may be able to join if you are 18 to 75 years old and have active UC for at least 3 months. The study aims to enroll 204 participants.

Study design
This is a Phase 2, randomized, double-blind, placebo-controlled study involving 204 participants across multiple centers. It compares different doses of SAR441566 to a placebo.
What's involved
The study involves a screening period of up to 28 days, followed by a 52-week treatment period. This includes 12 weeks of initial treatment and 40 weeks of continued treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a 2-week follow-up period after their treatment ends.

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NCT06867094

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Sanofi
~204 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:SAR441566SAR441566 matching Placebo

At a glance

Recruiting sites
113 of 115 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)
Measured over Week 12

Conditions

Colitis Ulcerative

Explore related trials

Ulcerative Colitis

Where it's being run

115 sites across 52 states
China9
India8
Germany7
Japan5
South Africa5
Florida4
Argentina4
Texas3

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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"):
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion

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.

What this trial measures

  • Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)Week 12

    Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore \>1 (stool frequency \[SF\] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding \[RB\] of 0 and modified Mayo Endoscopic Subscore \[mMES\] of 0 or 1 where 1 does not include friability). Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.