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New pill could tame severe ulcerative colitis Flare-Ups

NCT ID NCT06867094

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study tests an experimental drug called SAR441566 in about 204 adults with moderate-to-severe ulcerative colitis, a chronic bowel disease causing inflammation and symptoms like diarrhea and bleeding. Participants will receive either the drug or a placebo for up to 52 weeks to see if it can safely induce and maintain remission. The goal is to control the disease long-term, not cure it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 204 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colitis ulcerative

Contacts and locations

Locations

  • Bristol Hospital- Site Number : 8400017

    Bristol, Connecticut, 06010, United States

  • Clinical Research of Osceola- Site Number : 8400012

    Kissimmee, Florida, 34741, United States

  • Frontier Clinical Research - Uniontown- Site Number : 8400006

    Uniontown, Pennsylvania, 15401, United States

  • GCP Clinical Research- Site Number : 8400016

    Tampa, Florida, 33609, United States

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

    Sun City, Arizona, 85351, United States

  • GI Alliance - Glenview- Site Number : 8400005

    Glenview, Illinois, 60026, United States

  • Gastro Health & Nutrition- Site Number : 8400007

    Katy, Texas, 77494, United States

  • Hospital Ernesto Dornelles- Site Number : 0760003

    Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

  • Hospital de Clinicas de Porto Alegre- Site Number : 0760002

    Porto Alegre, Rio Grande do Sul, 90035903, Brazil

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

    New York, New York, 10029, United States

  • Illinois Gastroenterology Group- Site Number : 8400004

    Gurnee, Illinois, 60031, United States

  • Investigational Site Number : 0320001

    Buenos Aires, 1061, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, 1023, Argentina

  • Investigational Site Number : 0320003

    Buenos Aires, 1006, Argentina

  • Investigational Site Number : 0320004

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Investigational Site Number : 0320005

    Buenos Aires, 1125, Argentina

  • Investigational Site Number : 0360003

    Kurralta Park, South Australia, 5037, Australia

  • Investigational Site Number : 0360005

    Richmond, Victoria, 3121, Australia

  • Investigational Site Number : 0400001

    Vienna, 1090, Austria

  • Investigational Site Number : 0400002

    Salzburg, 5020, Austria

  • Investigational Site Number : 0400003

    Graz, 8036, Austria

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    Ghent, 9000, Belgium

  • Investigational Site Number : 1000001

    Burgas, 8000, Bulgaria

  • Investigational Site Number : 1000002

    Sofia, 1612, Bulgaria

  • Investigational Site Number : 1000003

    Rousse, 7002, Bulgaria

  • Investigational Site Number : 1240001

    Québec, Quebec, G1N 4V3, Canada

  • Investigational Site Number : 1240004

    Kentville, Nova Scotia, B4N 0A3, Canada

  • Investigational Site Number : 1240005

    Richmond Hill, Ontario, L4C 9M7, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8331143, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7500010, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 8330034, Chile

  • Investigational Site Number : 1560001

    Hangzhou, 310016, China

  • Investigational Site Number : 1560002

    Guangzhou, 510655, China

  • Investigational Site Number : 1560003

    Huizhou, 516001, China

  • Investigational Site Number : 1560004

    Jiazhuang, 050000, China

  • Investigational Site Number : 1560005

    Shanghai, 200120, China

  • Investigational Site Number : 1560008

    Luoyang, 471003, China

  • Investigational Site Number : 1560011

    Wuhan, 430014, China

  • Investigational Site Number : 1560014

    Linhai, 317000, China

  • Investigational Site Number : 1560017

    Huizhou, 516001, China

  • Investigational Site Number : 2030001

    Olomouc, 779 00, Czechia

  • Investigational Site Number : 2030002

    Ostrava, 710 00, Czechia

  • Investigational Site Number : 2500001

    Toulouse, 31059, France

  • Investigational Site Number : 2500002

    Vandœuvre-lès-Nancy, 54511, France

  • Investigational Site Number : 2500003

    Nice, 06202, France

  • Investigational Site Number : 2680001

    Tbilisi, 0180, Georgia

  • Investigational Site Number : 2680002

    Tbilisi, 0144, Georgia

  • Investigational Site Number : 2680003

    Tbilisi, 0160, Georgia

  • Investigational Site Number : 2760003

    Hanover, 30625, Germany

  • Investigational Site Number : 2760005

    Berlin, 10117, Germany

  • Investigational Site Number : 2760006

    Ulm, 89081, Germany

  • Investigational Site Number : 2760008

    Berlin, 14050, Germany

  • Investigational Site Number : 2760009

    Frankfurt, 60590, Germany

  • Investigational Site Number : 2760010

    Duisburg, 47055, Germany

  • Investigational Site Number : 2760011

    Tübingen, 72076, Germany

  • Investigational Site Number : 3000001

    Athens, 106 76, Greece

  • Investigational Site Number : 3000002

    Heraklion, 711 10, Greece

  • Investigational Site Number : 3000003

    Athens, 124 62, Greece

  • Investigational Site Number : 3480001

    Budapest, 1085, Hungary

  • Investigational Site Number : 3560001

    Surat, 395002, India

  • Investigational Site Number : 3560002

    Kolkata, 700020, India

  • Investigational Site Number : 3560003

    Jaipur, 302001, India

  • Investigational Site Number : 3560004

    Ludhiana, 141002, India

  • Investigational Site Number : 3560005

    Hyderabad, 500082, India

  • Investigational Site Number : 3560007

    Secunderabad, 500003, India

  • Investigational Site Number : 3560009

    Jaipur, 302004, India

  • Investigational Site Number : 3560010

    Visakhapatnam, 530040, India

  • Investigational Site Number : 3800001

    Padua, Padova, 35128, Italy

  • Investigational Site Number : 3800002

    Milan, Milano, 20132, Italy

  • Investigational Site Number : 3800003

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number : 3800004

    Pisa, 56124, Italy

  • Investigational Site Number : 3800006

    Genoa, Genova, 16132, Italy

  • Investigational Site Number : 3800007

    Alessandria, 15100, Italy

  • Investigational Site Number : 3800008

    Naples, Napoli, 80131, Italy

  • Investigational Site Number : 3800009

    Palermo, 90127, Italy

  • Investigational Site Number : 3800010

    Turin, Torino, 10126, Italy

  • Investigational Site Number : 3800011

    Rome, Roma, 00161, Italy

  • Investigational Site Number : 3920001

    Niigata, 950-1104, Japan

  • Investigational Site Number : 3920002

    Bunkyo-Ku, Tokyo, 113-8510, Japan

  • Investigational Site Number : 3920003

    Sapporo, Hokkaido, 004-0041, Japan

  • Investigational Site Number : 3920005

    Kashiwa, Chiba, 277-0871, Japan

  • Investigational Site Number : 3920006

    Kofu, Yamanashi, 400-0027, Japan

  • Investigational Site Number : 3920007

    Sapporo, Hokkaido, 065-0033, Japan

  • Investigational Site Number : 3920009

    Yahaba, Iwate, 028-3695, Japan

  • Investigational Site Number : 3920010

    Osaka, 530-0011, Japan

  • Investigational Site Number : 3920011

    Kodaira, Tokyo, 187-8510, Japan

  • Investigational Site Number : 3920012

    Hiroshima, 734-8530, Japan

  • Investigational Site Number : 3920013

    Yokohama, Kanagawa, 220-0041, Japan

  • Investigational Site Number : 3920014

    Kure, Hiroshima, 737-0811, Japan

  • Investigational Site Number : 3920015

    Tokyo, 108-8642, Japan

  • Investigational Site Number : 3920016

    Kagoshima, 892-0843, Japan

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship, 04-501, Poland

  • Investigational Site Number : 6160002

    Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

  • Investigational Site Number : 6160004

    Warsaw, Masovian Voivodeship, 03-580, Poland

  • Investigational Site Number : 6160005

    Wroclaw, Lower Silesian Voivodeship, 50-750, Poland

  • Investigational Site Number : 6160008

    Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

  • Investigational Site Number : 7100001

    Cape Town, 7708, South Africa

  • Investigational Site Number : 7100002

    Cape Town, 7405, South Africa

  • Investigational Site Number : 7100003

    Pretoria, 0002, South Africa

  • Investigational Site Number : 7100004

    KwaDukuza, 4449, South Africa

  • Investigational Site Number : 7100005

    Pretoria, 0157, South Africa

  • Investigational Site Number : 7920001

    Mersin, 33070, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Istanbul, 34899, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Izmir, 35100, Turkey (Türkiye)

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

    Charleston, South Carolina, 29401, United States

  • NexGen Research- Site Number : 8400020

    Lima, Ohio, 45805, United States

  • Novum Research- Site Number : 8400018

    Clermont, Florida, 34711, United States

  • Queens Village Primary Medical Center- Site Number : 8400011

    Queens Village, New York, 11428, United States

  • SI Research Associates- Site Number : 8400019

    Lubbock, Texas, 79424, United States

  • Texas Digestive Disease Consultants - Southlake- Site Number : 8400015

    Southlake, Texas, 76092, United States

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

    Ann Arbor, Michigan, 48109, United States

  • University of Washington Medical Center- Site Number : 8400014

    Seattle, Washington, 98195, United States

  • Washington Gastroenterology - Tacoma- Site Number : 8400009

    Tacoma, Washington, 98405, United States

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

    Miami Lakes, Florida, 33016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.