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New drug aims to free colitis patients from long-term steroid use

NCT ID NCT07156175

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an experimental drug called SAR444336 in 54 adults with microscopic colitis who are currently in remission using budesonide. The goal is to see if the drug can help them stay symptom-free without needing budesonide. Participants will receive either the study drug or a placebo, and researchers will monitor for side effects and how long remission lasts.

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 54 people

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

Started

Oct 2025

Expected to finish

May 2027

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 years and older

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 with histologically confirmed diagnosis of microscopic colitis (including all histological sub-types). * Receiving budesonide therapy. * Documented clinical remission from 2 weeks before screening. * At least 1 microscopic colitis relapse in the last 8 months prior to screening that required treatment with budesonide. * Body mass index within the range 18 to 35 kg/m2 (inclusive) at screening visit. * All contraceptive methods used by participants should be consistent with local regulations regarding the methods of contraception. Exclusion Criteria: * Significant neutrophilic/eosinophilic infiltration, crypt abscesses, granulomata, or any evidence of IBD other than microscopic colitis. * Evidence of infectious diarrhea in the 3 months prior to randomization. * Other active diarrheal conditions or suspicion of drug--induced microscopic colitis at screening, or diarrhea predominant irritable bowel syndrome. * Any current active viral, bacterial, or fungal infection or any medically relevant infection having occurred within 3 weeks before randomization. * Previous bowel surgeries. * Planned surgery while receiving study treatment. Dental surgeries or other types of minor surgery requiring only local anesthetic are allowed. * Other immunologic disorder, except controlled diabetes or thyroid disorder receiving appropriate treatment. * Presence or history of drug hypersensitivity associated with eosinophilia in the past 6 months. * History or presence of alcohol or illicit drug abuse within the past 2 years. * Excessive consumption of beverages containing xanthine bases. * History of solid organ transplant. * Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 2 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin. * Have experienced any of the following within 12 months before screening: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage III or IV heart failure. * Participants with a history or presence of another significant illness such as renal, neurological, ophthalmological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic disease, metabolic, pulmonary or lymphatic. * Live attenuated vaccines within 6 weeks of randomization and during the study. * Currently receiving or had treatment within 12 months prior to screening with B or T cell depleting agents. * At screening, have abnormal laboratory values or ECG abnormalities. * Participants with recent tuberculosis (TB) vaccination or positive TB test results. The above information was 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.

microscopic colitis

As listed by the trial registrant

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

Microscopic 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

    26 sites in 9 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

  • A.O.U. Città della Salute e della Scienza di Torino, Presidio Molinette, S.C. Gastroenterologia U., Investigational Site Number : 380002

    RECRUITING

    Turin, Torino, 10126, Italy

  • Azienda Ospedale Università Padova, Investigational Site Number : 380001

    RECRUITING

    Padua, Padova, 35128, Italy

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Investigational Site Number : 380004

    RECRUITING

    Milan, Milano, 20122, Italy

  • Fondazione Policlinico Gemelli IRCCS Roma, Investigational Site Number : 380003

    RECRUITING

    Rome, Roma, 00168, Italy

  • Investigational Site Number : 0560001

    RECRUITING

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    RECRUITING

    Ghent, 9000, Belgium

  • Investigational Site Number : 2080002

    RECRUITING

    Hvidovre, 2650, Denmark

  • Investigational Site Number : 2080003

    RECRUITING

    Aarhus, 8200, Denmark

  • Investigational Site Number : 2500001

    RECRUITING

    Créteil, 94010, France

  • Investigational Site Number : 2500002

    RECRUITING

    Montfermeil, 93370, France

  • Investigational Site Number : 2500003

    RECRUITING

    Pessac, 33604, France

  • Investigational Site Number : 2760001

    RECRUITING

    Frankfurt, 60389, Germany

  • Investigational Site Number : 2760002

    RECRUITING

    Potsdam, 14467, Germany

  • Investigational Site Number : 2760003

    RECRUITING

    Tübingen, 72076, Germany

  • Investigational Site Number : 2760004

    RECRUITING

    Ulm, 89081, Germany

  • Investigational Site Number : 2760005

    RECRUITING

    Ludwigshafen, 67067, Germany

  • Investigational Site Number : 3480002

    RECRUITING

    Budapest, 1085, Hungary

  • Investigational Site Number : 3480003

    RECRUITING

    Székesfehérvár, 8000, Hungary

  • Investigational Site Number : 6160002

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Investigational Site Number : 6160003

    RECRUITING

    Warsaw, Masovian Voivodeship, 00-728, Poland

  • Investigational Site Number : 6160004

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-229, Poland

  • Investigational Site Number : 7520001

    RECRUITING

    Linköping, 581 85, Sweden

  • Investigational Site Number : 7520002

    RECRUITING

    Stockholm, 113 61, Sweden

  • Investigational Site Number : 7520003

    RECRUITING

    Stockholm, 116 91, Sweden

  • Investigational Site Number : 8260001

    RECRUITING

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Investigational Site Number : 8260002

    RECRUITING

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

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