Recruiting
Phase 2

SAR441566

Sponsor:

Sanofi

Code:

NCT06867094

Conditions

Colitis Ulcerative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SAR441566

SAR441566 matching Placebo

Study Details

Brief summary:

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.

Conditions

Colitis Ulcerative

Study ID

NCT06867094

Start date

Mar 28, 2025

Status verified date

Jun, 2026

Completion date

May 11, 2028

Anticipated

Primary completion date

Jul 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAR441566 dose regimen 1

Participants will receive SAR441566 dose regimen 1

experimental: SAR441566 dose regimen 2

Participants will receive SAR441566 dose regimen 2

experimental: SAR441566 dose regimen 3

Participants will receive SAR441566 dose regimen 3

placebo comparator: Placebo

Participants will receive SAR441566-matching placebo

Interventions

SAR441566

Pharmaceutical form: Tablet Route of administration: Oral

SAR441566 matching Placebo

Pharmaceutical form: Tablet Route of administration: Oral

Primary outcome measure

  • Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS) [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003

Recruiting

Sun City, Arizona, United States, 85351

Bristol Hospital- Site Number : 8400017

Recruiting

Bristol, Connecticut, United States, 06010

Novum Research- Site Number : 8400018

Recruiting

Clermont, Florida, United States, 34711

Clinical Research of Osceola- Site Number : 8400012

Recruiting

Kissimmee, Florida, United States, 34741

Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002

Recruiting

Miami Lakes, Florida, United States, 33016

GCP Clinical Research- Site Number : 8400016

Recruiting

Tampa, Florida, United States, 33609

GI Alliance - Glenview- Site Number : 8400005

Recruiting

Glenview, Illinois, United States, 60026

Illinois Gastroenterology Group- Site Number : 8400004

Recruiting

Gurnee, Illinois, United States, 60031

University of Michigan Health System - Ann Arbor- Site Number : 8400010

Recruiting

Ann Arbor, Michigan, United States, 48109

Icahn School of Medicine at Mount Sinai- Site Number : 8400001

Recruiting

New York, New York, United States, 10029

Queens Village Primary Medical Center- Site Number : 8400011

Recruiting

Queens Village, New York, United States, 11428

NexGen Research- Site Number : 8400020

Recruiting

Lima, Ohio, United States, 45805

Frontier Clinical Research - Uniontown- Site Number : 8400006

Recruiting

Uniontown, Pennsylvania, United States, 15401

Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008

Recruiting

Charleston, South Carolina, United States, 29401

Gastro Health & Nutrition- Site Number : 8400007

Recruiting

Katy, Texas, United States, 77494

SI Research Associates- Site Number : 8400019

Recruiting

Lubbock, Texas, United States, 79424

Texas Digestive Disease Consultants - Southlake- Site Number : 8400015

Recruiting

Southlake, Texas, United States, 76092

University of Washington Medical Center- Site Number : 8400014

Recruiting

Seattle, Washington, United States, 98195

Washington Gastroenterology - Tacoma- Site Number : 8400009

Recruiting

Tacoma, Washington, United States, 98405

Investigational Site Number : 1240004

Recruiting

Kentville, Nova Scotia, Canada, B4N 0A3

Investigational Site Number : 1240005

Recruiting

Richmond Hill, Ontario, Canada, L4C 9M7

Investigational Site Number : 1240001

Recruiting

Québec, Quebec, Canada, G1N 4V3

More Information

Sponsor

Sanofi

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-06-23.