A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission

February 23, 2026 updated by: Sanofi

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of SAR444336 in Participants With Microscopic Colitis in Clinical Remission With Budesonide

This is a parallel, placebo-controlled, multicenter, randomized, double-blind, Phase 2, proof of concept study. The study aims to evaluate the efficacy and safety of SAR444336 in adult participants with microscopic colitis. Participants are required to have a histologically confirmed diagnosis of microscopic colitis, be in clinical remission and be receiving budesonide therapy. The overall study duration is approximately 32 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • Investigational Site Number : 0560002
      • Leuven, Belgium, 3000
        • Recruiting
        • Investigational Site Number : 0560001
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Investigational Site Number : 2080003
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Investigational Site Number : 2080002
  • France
      • Créteil, France, 94010
        • Recruiting
        • Investigational Site Number : 2500001
      • Montfermeil, France, 93370
        • Recruiting
        • Investigational Site Number : 2500002
      • Pessac, France, 33604
        • Recruiting
        • Investigational Site Number : 2500003
  • Germany
      • Frankfurt, Germany, 60389
        • Recruiting
        • Investigational Site Number : 2760001
      • Ludwigshafen, Germany, 67067
        • Recruiting
        • Investigational Site Number : 2760005
      • Potsdam, Germany, 14467
        • Recruiting
        • Investigational Site Number : 2760002
      • Tübingen, Germany, 72076
        • Recruiting
        • Investigational Site Number : 2760003
      • Ulm, Germany, 89081
        • Recruiting
        • Investigational Site Number : 2760004
  • Hungary
      • Budapest, Hungary, 1085
        • Recruiting
        • Investigational Site Number : 3480002
      • Székesfehérvár, Hungary, 8000
        • Recruiting
        • Investigational Site Number : 3480003
  • Italy
    • Milano
      • Milan, Milano, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Investigational Site Number : 380004
        • Contact:
        • Principal Investigator:
          • Gian Eugenio Tontini
    • Padova
      • Padua, Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedale Università Padova, Investigational Site Number : 380001
        • Principal Investigator:
          • Edoardo Vincenzo Savarino
        • Contact:
    • Roma
      • Rome, Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Gemelli IRCCS Roma, Investigational Site Number : 380003
        • Principal Investigator:
          • Antonio Gasbarrini
        • Contact:
    • Torino
      • Turin, Torino, Italy, 10126
        • Recruiting
        • A.O.U. Città della Salute e della Scienza di Torino, Presidio Molinette, S.C. Gastroenterologia U., Investigational Site Number : 380002
        • Principal Investigator:
          • Davide Giuseppe Ribaldone
        • Contact:
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-229
        • Recruiting
        • Investigational Site Number : 6160004
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • Recruiting
        • Investigational Site Number : 6160002
      • Warsaw, Masovian Voivodeship, Poland, 00-728
        • Recruiting
        • Investigational Site Number : 6160003
  • Sweden
      • Linköping, Sweden, 581 85
        • Recruiting
        • Investigational Site Number : 7520001
      • Stockholm, Sweden, 116 91
        • Recruiting
        • Investigational Site Number : 7520003
      • Stockholm, Sweden, 113 61
        • Recruiting
        • Investigational Site Number : 7520002
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Recruiting
        • Investigational Site Number : 8260002
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • Investigational Site Number : 8260001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAR444336
Each participant will receive several injections of SAR444336. Budesonide will be taken at the dose administered by the physician.
Drug: SAR444336
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Placebo Comparator: Placebo
Each participant will receive several injections of placebo. Budesonide will be taken at the dose administered by the physician.
Drug: Placebo
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with sustained steroid-free clinical remission
Time Frame: up to week 24
Clinical remission defined as no relapse during the 24-week period.
up to week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time Frame: up to week 28
up to week 28
Incidence of study investigational medicinal product (IMP) permanent discontinuations and study withdrawals due to treatment-emergent adverse events (TEAEs)
Time Frame: up to week 28
up to week 28
Plasma concentrations of SAR444336
Time Frame: through week 24
through week 24
Incidence of treatment-emergent anti-drug antibody (ADA) against SAR444336
Time Frame: through week 24
through week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2025

Primary Completion (Estimated)

April 8, 2027

Study Completion (Estimated)

May 6, 2027

Study Registration Dates

First Submitted

September 3, 2025

First Submitted That Met QC Criteria

September 3, 2025

First Posted (Actual)

September 5, 2025

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT18053
  • 2024-519495-83 (Registry Identifier: CTIS)
  • U1111-1314-5201 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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