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New pill could tame stubborn ulcerative colitis

NCT ID NCT05588843

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This Phase 2 trial tests an oral drug called SAR443122 in 187 adults with moderate to severe ulcerative colitis who haven't responded well to other treatments. Participants receive either the drug or a placebo for up to 52 weeks. The goal is to see if the drug can safely help achieve remission and control symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAR443122 (an oral drug)
What this could lead to
If successful, this could provide a new oral treatment option to help control moderate to severe ulcerative colitis and achieve remission.
What could go wrong
This is an early Phase 2 trial with only 187 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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

187 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Dec 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 who have clinical evidence of active Ulcerative Colitis \[UC\] for ≥3 months before screening as confirmed by endoscopy during the screening period. * Participants must have a minimum disease extent of 15 centimeters from the anal verge. * Participants are inadequate or non-responders, have shown loss of response, or are intolerant to at least 1 of following approved treatments: amino-salicylate, corticosteroids, immunosuppressants or biologics other than natalizumab (Tysabri®) or small molecules. * Participants on corticosteroids must be on a stable dose ≥2 weeks prior to screening and during screening period. * Participants on methotrexate, azathioprine or 6- mercaptopurine must be on treatment for at least 8 weeks prior to screening; and on a stable dose ≥4 weeks prior to screening and during screening period. * Participants on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥4 weeks prior to screening and during screening period. * Participants on advanced therapies must have 1) last administration at least 5 half-lives prior to randomization, or 2) undetectable level of the biologic in their blood prior to randomization. * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding. Exclusion Criteria: * Participants with Crohn's Disease (CD). * Participants with diagnosis of indeterminate colitis or microscopic colitis. * Participants with stool sample positive for culture for aerobic pathogens or C difficile. * Participants with prior colectomy or anticipated colectomy during their participation in the study. * Participants with presence of ileal pouch or ostomy. * Participants with fulminant disease or toxic megacolon. * Participants with colonic dysplasia except for adenoma. * Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition (TPN). * Participants with history of recurrent or recent serious infection that has not resolved within 4 weeks prior to randomization. * Participants presenting with active malignancies or recurrence of malignancy within the 5 years before screening. * Participants with a history or presence of another significant illness that according to the investigator's judgment would adversely affect the subject's ability to participate in this study. * Participants presenting with fever (≥38°C) or persistent chronic or active recurring infection within 4 weeks prior to the Screening Visit requiring treatment with antibiotics, antivirals, or any history of frequent recurrent infections deemed unacceptable per investigator's judgment. * Participants who were administered any live (attenuated) vaccine within 3 months prior to the randomization Visit. * Participants with a history of recurrent herpes zoster. * Participants with uncontrolled diabetes, defined as HbA1c ≥9.0% at the Screening Visit. * Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated active or latent TB per local guidelines will be excluded from the study unless it is documented by a specialist that the participant has been adequately treated and can now start treatment with the RIPK1 kinase inhibitor. * Participants presenting with opportunistic infections within six months prior to screening or while receiving anti-TNF treatment in the last 6 months. * Participants undergoing hemodialysis or peritoneal dialysis. * Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at screening. * Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit. Participants that were treated for HCV and clear the virus documented by HCV RNA by PCR below the limit of quantification can be eligible. * Positive COVID-19 test, suspected COVID-19 infection or known exposure to COVID-19 during the screening period. * History of COVID-19 infection within 4 weeks prior to Screening; history of mechanical ventilation or extracorporeal membrane oxygenation (ECMO) due to COVID-19 infection within 3 months prior to Screening or with residual significant complications from COVID-19 making it unsafe for the participant to enter this study. * Participants presenting alcohol or drug dependency within the 2 years prior to the Screening Visit. * Participants with unexplained, uncontrolled, or untreated thyroid disease or unexplained abnormal serum prolactin levels at screening. * Participants under cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide or tacrolimus treatment within 4 weeks prior to screening. * Participants with previous exposure to natalizumab (Tysabri®). * Participants with previous exposure to RIPK1 inhibitor. * Participants under antidiarrheals within 2 weeks prior to screening and during screening period. * Participants under prednisone \>25 mg/day (or equivalent). * Participants under budesonide \>9 mg/day. * Participants who received intravenous corticosteroids or cytapheresis therapy within 2 weeks prior to screening or during screening. * Participants who were rectally administered topical 5-aminosalicylate or corticosteroids within 4 weeks prior to screening. * Participants who received therapeutic enema or suppository, other than required for colonoscopy or flexible sigmoidoscopy within 4 weeks prior to screening or during screening. * Participants who received antibiotics for UC or gastrointestinal infection within 4 weeks prior to screening. * Participants who have taken other investigational medications within 2 months or 5 half--lives, (whichever is longer) prior to screening. * Presence of significant laboratory findings at the Screening Visit. The above information is not intended to contain all considerations relevant to a patient'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

  • 1960 Family Practice- Site Number : 8400019

    Houston, Texas, 77090, United States

  • Agile Clinical Research Trials- Site Number : 8400024

    Atlanta, Georgia, 30328, United States

  • BVL Research- Site Number : 8400015

    Liberty, Missouri, 64068, United States

  • Endeavor Health - Evanston Hospital- Site Number : 8400027

    Evanston, Illinois, 60201, United States

  • GI Alliance - Mansfield- Site Number : 8400010

    Mansfield, Texas, 76063, United States

  • Gastro One - Walnut Run Road- Site Number : 8400002

    Cordova, Tennessee, 38018, United States

  • Houston Methodist Hospital- Site Number : 8400023

    Houston, Texas, 77030, United States

  • Integrity Research - Sugar Land- Site Number : 8400026

    Sugar Land, Texas, 77478, United States

  • Investigational Site Number : 0320001

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, 1128, Argentina

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, 2002, Argentina

  • Investigational Site Number : 0320004

    Córdoba, 5000, Argentina

  • Investigational Site Number : 0320005

    Córdoba, 5000, Argentina

  • Investigational Site Number : 0320006

    CABA, Buenos Aires, C1023AAB, Argentina

  • Investigational Site Number : 0320007

    Salta, 4400, Argentina

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7500010, Chile

  • Investigational Site Number : 1520004

    Talcahuano, Biobio, 2687000, Chile

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 7620001, Chile

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 8380456, Chile

  • Investigational Site Number : 1520007

    Viña del Mar, Valparaiso, 2540364, Chile

  • Investigational Site Number : 1560001

    Guangzhou, 510655, China

  • Investigational Site Number : 1560002

    Shenyang, 110004, China

  • Investigational Site Number : 1560003

    Hefei, 230022, China

  • Investigational Site Number : 1560004

    Hangzhou, 310016, China

  • Investigational Site Number : 1560005

    Shanghai, 200025, China

  • Investigational Site Number : 1560006

    Nanchang, 330006, China

  • Investigational Site Number : 1560007

    Nanjing, 210008, China

  • Investigational Site Number : 2030001

    Hradec Králové, 500 12, Czechia

  • Investigational Site Number : 2030002

    Klatovy, 339 01, Czechia

  • Investigational Site Number : 2030003

    Prague, 190 00, Czechia

  • Investigational Site Number : 2030007

    České Budějovice, 370 01, Czechia

  • Investigational Site Number : 2500001

    Vandœuvre-lès-Nancy, 54511, France

  • Investigational Site Number : 2500006

    Neuilly-sur-Seine, 92200, France

  • Investigational Site Number : 2500007

    Marseille, 13915, France

  • Investigational Site Number : 2500008

    Nantes, 44314, France

  • Investigational Site Number : 2680002

    Tbilisi, 0160, Georgia

  • Investigational Site Number : 2680003

    Batumi, 6000, Georgia

  • Investigational Site Number : 2680004

    Tbilisi, 0186, Georgia

  • Investigational Site Number : 2680005

    Kutaisi, 4600, Georgia

  • Investigational Site Number : 2760001

    Kiel, 24105, Germany

  • Investigational Site Number : 2760003

    Fulda, 36043, Germany

  • Investigational Site Number : 2760006

    Ulm, 89081, Germany

  • Investigational Site Number : 2760008

    Ludwigshafen, 67067, Germany

  • Investigational Site Number : 3480001

    Békéscsaba, 5600, Hungary

  • Investigational Site Number : 3480002

    Budapest, 1085, Hungary

  • Investigational Site Number : 3480005

    Budapest, 1062, Hungary

  • Investigational Site Number : 3480006

    Gyöngyös, 3200, Hungary

  • Investigational Site Number : 3560001

    Jaipur, 302007, India

  • Investigational Site Number : 3560003

    Gurgaon, 122002, India

  • Investigational Site Number : 3560004

    Ludhiana, 141010, India

  • Investigational Site Number : 3560005

    Kochi, 682017, India

  • Investigational Site Number : 3560006

    Thiruvananthapuram, 695011, India

  • Investigational Site Number : 3560007

    Pune, 411001, India

  • Investigational Site Number : 3560008

    Rajkot, 360005, India

  • Investigational Site Number : 3560009

    Jaipur, 302001, India

  • Investigational Site Number : 3560010

    Surat, 395002, India

  • Investigational Site Number : 3560011

    Surat, 395009, India

  • Investigational Site Number : 3560012

    Secunderabad, 500003, India

  • Investigational Site Number : 3560013

    New Delhi, 110029, India

  • Investigational Site Number : 3800001

    Pavia, 27100, Italy

  • Investigational Site Number : 3800002

    Rome, Roma, 00168, Italy

  • Investigational Site Number : 3800003

    Milan, 20132, Italy

  • Investigational Site Number : 3800004

    Catanzaro, 88100, Italy

  • Investigational Site Number : 3800005

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number : 3800006

    Palermo, 90146, Italy

  • Investigational Site Number : 3800007

    Milan, Milano, 20097, Italy

  • Investigational Site Number : 3800008

    Bolzano, Bolzano / Bozen, 39100, Italy

  • Investigational Site Number : 3920001

    Ōita, 870-0823, Japan

  • Investigational Site Number : 3920002

    Fukushima, 720-0825, Japan

  • Investigational Site Number : 3920003

    Osaka, 540-0006, Japan

  • Investigational Site Number : 3920005

    Hamamatsu, Shizuoka, 432-8061, Japan

  • Investigational Site Number : 3920006

    Saitama, 330-8553, Japan

  • Investigational Site Number : 3920007

    Chūō, Tokyo, 104-0061, Japan

  • Investigational Site Number : 3920011

    Nagaoka, Niigata, 940-2108, Japan

  • Investigational Site Number : 4840001

    Chihuahua City, 31000, Mexico

  • Investigational Site Number : 4840002

    Durango, 34000, Mexico

  • Investigational Site Number : 4840003

    Chihuahua City, 31203, Mexico

  • Investigational Site Number : 4840005

    Mérida, Yucatán, 97070, Mexico

  • Investigational Site Number : 4840006

    Tlalnepantla, 54055, Mexico

  • Investigational Site Number : 5280001

    Amsterdam, 1081 HV, Netherlands

  • Investigational Site Number : 5280002

    Nijmegen, 6525 GA, Netherlands

  • Investigational Site Number : 6160002

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Investigational Site Number : 6160004

    Wroclaw, Lower Silesian Voivodeship, 50-162, Poland

  • Investigational Site Number : 6160006

    Gdynia, Pomeranian Voivodeship, 81-384, Poland

  • Investigational Site Number : 6160009

    Katowice, Silesian Voivodeship, 40-748, Poland

  • Investigational Site Number : 6160010

    Łęczna, Lublin Voivodeship, 21-010, Poland

  • Investigational Site Number : 6160011

    Tychy, Silesian Voivodeship, 43-100, Poland

  • Investigational Site Number : 6160015

    Krakow, 31-156, Poland

  • Investigational Site Number : 6160016

    Katowice, 40-600, Poland

  • Investigational Site Number : 6160017

    Warsaw, Masovian Voivodeship, 02-786, Poland

  • Investigational Site Number : 6160018

    Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800, Poland

  • Investigational Site Number : 6420001

    Düsseldorf, 40225, Germany

  • Investigational Site Number : 6420002

    Cluj-Napoca, 400006, Romania

  • Investigational Site Number : 7030001

    Nitra, 949 01, Slovakia

  • Investigational Site Number : 7030002

    Košice, 040 13, Slovakia

  • Investigational Site Number : 7030003

    Banská Bystrica, 975 17, Slovakia

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08022, Spain

  • Investigational Site Number : 8260002

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

  • Investigational Site Number : 8260003

    Warrington, WA5 1LZ, United Kingdom

  • Investigational Site Number : 8260006

    London, London, City of, SE1 9RT, United Kingdom

  • NY Scientific- Site Number : 8400013

    Brooklyn, New York, 11235, United States

  • Om Research - Lancaster - 15th Street West- Site Number : 8400014

    Lancaster, California, 93534, United States

  • Pioneer Clinical Research - New York- Site Number : 8400017

    New York, New York, 10016, United States

  • Richmond VA Medical Center- Site Number : 8400022

    Richmond, Virginia, 23249, United States

  • Sanmora Bespoke Clinical Research Solutions- Site Number : 8400016

    East Orange, New Jersey, 07018, United States

  • Vector Clinical Trials- Site Number : 8400004

    Las Vegas, Nevada, 89128, United States

More trials for these conditions

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