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Clinical Trials in India / NCT06867094
Active, not recruiting Phase 2

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

NCT06867094 · tracked via the Priya Life Science India tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2025-03-28
Last updated
2026-09-11

Condition(s) studied

Colitis Ulcerative

Investigational drug(s) / intervention(s)

SAR441566SAR441566 matching Placebo

SAR441566: Pharmaceutical form: Tablet Route of administration: Oral

SAR441566 matching Placebo: Pharmaceutical form: Tablet Route of administration: Oral

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (115)

FacilityCityRegionStatus
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003 Sun City Arizona
Bristol Hospital- Site Number : 8400017 Bristol Connecticut
Novum Research- Site Number : 8400018 Clermont Florida
Clinical Research of Osceola- Site Number : 8400012 Kissimmee Florida
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002 Miami Lakes Florida
GCP Clinical Research- Site Number : 8400016 Tampa Florida
GI Alliance - Glenview- Site Number : 8400005 Glenview Illinois
Illinois Gastroenterology Group- Site Number : 8400004 Gurnee Illinois
University of Michigan Health System - Ann Arbor- Site Number : 8400010 Ann Arbor Michigan
Icahn School of Medicine at Mount Sinai- Site Number : 8400001 New York New York
Queens Village Primary Medical Center- Site Number : 8400011 Queens Village New York
NexGen Research- Site Number : 8400020 Lima Ohio
Frontier Clinical Research - Uniontown- Site Number : 8400006 Uniontown Pennsylvania
Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008 Charleston South Carolina
Gastro Health & Nutrition- Site Number : 8400007 Katy Texas
SI Research Associates- Site Number : 8400019 Lubbock Texas
Texas Digestive Disease Consultants - Southlake- Site Number : 8400015 Southlake Texas
University of Washington Medical Center- Site Number : 8400014 Seattle Washington
Washington Gastroenterology - Tacoma- Site Number : 8400009 Tacoma Washington
Investigational Site Number : 0320004 San Miguel de Tucumán Tucumán Province
Investigational Site Number : 0320003 Buenos Aires Argentina
Investigational Site Number : 0320002 Buenos Aires Argentina
Investigational Site Number : 0320001 Buenos Aires Argentina
Investigational Site Number : 0320005 Buenos Aires Argentina
Investigational Site Number : 0360003 Kurralta Park South Australia
Investigational Site Number : 0360005 Richmond Victoria
Investigational Site Number : 0400003 Graz Austria
Investigational Site Number : 0400002 Salzburg Austria
Investigational Site Number : 0400001 Vienna Austria
Investigational Site Number : 0560002 Ghent Belgium
Investigational Site Number : 0560001 Leuven Belgium
Hospital de Clinicas de Porto Alegre- Site Number : 0760002 Porto Alegre Rio Grande do Sul
Hospital Ernesto Dornelles- Site Number : 0760003 Porto Alegre Rio Grande do Sul
Investigational Site Number : 1000001 Burgas Bulgaria
Investigational Site Number : 1000003 Rousse Bulgaria
Investigational Site Number : 1000002 Sofia Bulgaria
Investigational Site Number : 1240004 Kentville Nova Scotia
Investigational Site Number : 1240005 Richmond Hill Ontario
Investigational Site Number : 1240001 Québec Quebec
Investigational Site Number : 1520002 Santiago Reg Metropolitana de Santiago

+ 75 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06867094 on ClinicalTrials.gov ↗ ← All trials in India