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New hope for ulcerative colitis sufferers: experimental drug enters key trial

NCT ID NCT06975722

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new drug called SAR442970 for people with moderate to severe ulcerative colitis, a condition that causes inflammation and sores in the colon. About 99 adults will receive either the drug or a placebo to see if it can help control the disease and reduce symptoms. The trial lasts up to 168 weeks, with an option for long-term treatment.

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 99 people

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

Started

Jul 2025

Expected to finish

Oct 2029

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 had clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period * Must have 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, mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a minimum disease extent of 15 cm from the anal verge * Must have received prior treatment for UC (either "a" or "b" below or combination of both): 1. History of inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: amino-salicylates, corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine, or history of corticosteroid dependence (defined as an inability to successfully taper corticosteroids without recurrence of UC) AND history of no prior exposure to Advanced Therapies (ATs), such as a biologic agent used to treat UC or advanced small molecules used to treat UC 2. History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent used to treat UC or advanced small molecules used to treat 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 Crohn's Disease (CD), indeterminate colitis or microscopic colitis * Participants with fecal sample positive for culture/ova for aerobic pathogens or positive for Clostridium difficile B toxin in stools * Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomy during their participation in the study * Participants with the following ongoing known complications of UC: fulminant disease, toxic megacolon or colonic dysplasia except for adenoma * Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition * History of recurrent or recent serious infection within 4 weeks of screening, or infection(s) requiring hospitalization or treatment with IV anti-infectives within 30 days prior to baseline, or infections(s) requiring oral anti-infectives within 14 days prior to baseline, except as required as part of an anti-Tuberculosis (TB) regimen * Known history of or suspected significant current immunosuppression. * History or solid organ transplant or splenectomy * History of moderate to severe congestive heart failure (New York Health Association Class III or IV), or recent cerebrovascular accident. * History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease * Participants with a history of malignancy or lymphoproliferative disease other than adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin * Participants with a diagnosis of inflammatory conditions other than UC (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc.) * History of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at Screening * History of Interstitial Lung Disease * Participants with any of the following results at Screening: * Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or, * Positive total Hepatitis B core antibody (anti-HBc) confirmed by positive Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) or, * Positive Hepatitis C Virus (HCV) antibody * Screening laboratory and other analyses showing abnormal results * History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol 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.

Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    66 sites in 12 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Investigational Site Number: 0360001

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Investigational Site Number: 0360003

    RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Investigational Site Number: 1560001

    RECRUITING

    Hangzhou, 310016, China

  • Investigational Site Number: 1560002

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Investigational Site Number: 1560003

    RECRUITING

    Wuxi, Jiangsu, 214023, China

  • Investigational Site Number: 1560004

    RECRUITING

    Huizhou, Ghangdong, 516001, China

  • Investigational Site Number: 1560005

    RECRUITING

    Guangzhou, Guangdong, 510655, China

  • Investigational Site Number: 1560007

    RECRUITING

    Ningbo, 315010, China

  • Investigational Site Number: 1560008

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • Investigational Site Number: 1560009

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • Investigational Site Number: 2030001

    RECRUITING

    Brno, JM, 61500, Czechia

  • Investigational Site Number: 2030002

    RECRUITING

    Slaný, 27401, Czechia

  • Investigational Site Number: 2500001

    RECRUITING

    Saint-Priest-en-Jarez, 42270, France

  • Investigational Site Number: 2500002

    RECRUITING

    Lille, 59037, France

  • Investigational Site Number: 2500003

    RECRUITING

    Toulouse, 31400, France

  • Investigational Site Number: 2500004

    WITHDRAWN

    Vandœuvre-lès-Nancy, 54500, France

  • Investigational Site Number: 2500005

    RECRUITING

    Pierre-Bénite, 69495, France

  • Investigational Site Number: 2760001

    RECRUITING

    Minden, Northwest, 32423, Germany

  • Investigational Site Number: 2760003

    RECRUITING

    Ulm, 89081, Germany

  • Investigational Site Number: 2760005

    RECRUITING

    Kiel, Schleswig-Holstein, 24105, Germany

  • Investigational Site Number: 3480001

    RECRUITING

    Vác, 2600, Hungary

  • Investigational Site Number: 3480002

    RECRUITING

    Budapest, 1088, Hungary

  • Investigational Site Number: 3480003

    RECRUITING

    Budapest, 1066, Hungary

  • Investigational Site Number: 3920001

    RECRUITING

    Morioka, 020-8505, Japan

  • Investigational Site Number: 3920002

    RECRUITING

    Kashiwa, Chiba, 277-0871, Japan

  • Investigational Site Number: 3920003

    RECRUITING

    Hirosaki, 036-8545, Japan

  • Investigational Site Number: 3920004

    RECRUITING

    Nishinomiya, 663-8501, Japan

  • Investigational Site Number: 3920005

    RECRUITING

    Hamamatsu, 431-3192, Japan

  • Investigational Site Number: 3920006

    RECRUITING

    Ōita, Oita Prefecture, 870-0033, Japan

  • Investigational Site Number: 4980001

    RECRUITING

    Chisinau, 2025, Moldova

  • Investigational Site Number: 6160001

    RECRUITING

    Wroclaw, 52-210, Poland

  • Investigational Site Number: 6160002

    RECRUITING

    Bydgoszcz, 85-229, Poland

  • Investigational Site Number: 6160003

    RECRUITING

    Warsaw, 04-501, Poland

  • Investigational Site Number: 6160004

    RECRUITING

    Warsaw, 00-189, Poland

  • Investigational Site Number: 6160005

    RECRUITING

    Sopot, 81-756, Poland

  • Investigational Site Number: 6160006

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 53-149, Poland

  • Investigational Site Number: 6160007

    RECRUITING

    Katowice, 40-748, Poland

  • Investigational Site Number: 6160008

    RECRUITING

    Tychy, 43-100, Poland

  • Investigational Site Number: 6160009

    RECRUITING

    Chojnice, 89-600, Poland

  • Investigational Site Number: 7240001

    RECRUITING

    Las Palmas de Gran Canaria, 35010, Spain

  • Investigational Site Number: 7240002

    RECRUITING

    Madrid, 28046, Spain

  • Investigational Site Number: 8260001

    RECRUITING

    London, E11 1NR, United Kingdom

  • Investigational Site Number: 8260002

    RECRUITING

    Northwich, CHW, CW9 7LS, United Kingdom

  • Investigational Site Number: 8260003

    RECRUITING

    Bury, BL9 7TD, United Kingdom

  • Investigational Site Number: 8260004

    RECRUITING

    London, SE1 7EH, United Kingdom

  • Investigational Site Number: 8400001

    RECRUITING

    Miami, Florida, 33134, United States

  • Investigational Site Number: 8400002

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • Investigational Site Number: 8400003

    RECRUITING

    Lighthouse PT, Florida, 33064, United States

  • Investigational Site Number: 8400005

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Investigational Site Number: 8400006

    RECRUITING

    Lancaster, California, 93534, United States

  • Investigational Site Number: 8400007

    RECRUITING

    Ogden, Utah, 84405, United States

  • Investigational Site Number: 8400009

    RECRUITING

    Escondido, California, 92025, United States

  • Investigational Site Number: 8400010

    RECRUITING

    Palmetto Bay, Florida, 33176, United States

  • Investigational Site Number: 8400011

    RECRUITING

    Miami, Florida, 33136, United States

  • Investigational Site Number: 8400012

    RECRUITING

    Wyoming, Michigan, 49519, United States

  • Investigational Site Number: 8400013

    RECRUITING

    Harrisburg, Pennsylvania, 17110, United States

  • Investigational Site Number: 8400014

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Investigational Site Number: 8400017

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Investigational Site Number: 8400018

    RECRUITING

    Marietta, Georgia, 30060, United States

  • Investigational Site Number: 8400019

    RECRUITING

    Tampa, Florida, 33609, United States

  • Investigational Site Number: 8400021

    RECRUITING

    New York, New York, 10029, United States

  • Investigational Site Number: 8400023

    RECRUITING

    Houston, Texas, 77030, United States

  • Investigational Site Number: 8400024

    RECRUITING

    Jacksonville, Florida, 32258, United States

  • Investigational Site Number: 8400025

    RECRUITING

    Thousand Oaks, California, 91360, United States

  • Investigational Site Number: 8400029

    RECRUITING

    Queens Village, New York, 11428, United States

  • Investigational Site Number: 8400030

    RECRUITING

    Kissimmee, Florida, 347441, United States

  • Investigative Site: 2500006

    RECRUITING

    Nice, 6200, France

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