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Investigating SAR441566 for treating ulcerative colitis

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 Ulcerative Colitis

Phase 2 Interventional Sanofi · NCT06867094

This study is testing a new medication called SAR441566 to see if it can help adults with moderate-to-severe ulcerative colitis feel better and achieve remission.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment204 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsnatalizumab
Locations115 sites (Sun City, Arizona and 114 other locations)
Trial IDNCT06867094 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial evaluates the efficacy and safety of SAR441566 in adults with moderate-to-severe ulcerative colitis. The study is designed as a randomized, double-blind, placebo-controlled trial, with participants receiving different doses of the medication over a treatment period of up to 52 weeks. The primary goal is to assess the effectiveness of SAR441566 in achieving clinical remission, with a follow-up period of 2 weeks after treatment. An open-label period may also be available for eligible participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with active moderate-to-severe ulcerative colitis confirmed by endoscopy.

Not a fit: Patients with mild ulcerative colitis or those who have not previously received treatment for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from moderate-to-severe ulcerative colitis.

How similar studies have performed: Other studies have shown promise with similar therapeutic approaches, but this specific treatment is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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"):

  1. 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
  2. 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.

Exclusion Criteria:

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 this trial is running

Sun City, Arizona and 114 other locations

+65 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colitis Ulcerative
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.