RECRUITING
Phase 2
ClinicalTrials.gov
A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07156175
Registry updated: 2026-09-23
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Check Eligibility →Description
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.
Interventions
-
SAR444336
(Drug)
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
-
Placebo
(Drug)
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Eligibility criteria
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.
Conditions
Microscopic Colitis
Locations
- Investigational Site Number : 0560001 — Leuven, Belgium
- Investigational Site Number : 2080003 — Aarhus, Denmark
- Investigational Site Number : 2080002 — Hvidovre, Denmark
- Investigational Site Number : 2500001 — Créteil, France
- Investigational Site Number : 2500002 — Montfermeil, France
- Investigational Site Number : 2500003 — Pessac, France
- Investigational Site Number : 2760001 — Frankfurt, Germany
- Investigational Site Number : 2760005 — Ludwigshafen, Germany
- Investigational Site Number : 2760003 — Tübingen, Germany
- Investigational Site Number : 2760004 — Ulm, Germany
- Investigational Site Number : 3480002 — Budapest, Hungary
- Investigational Site Number : 3480003 — Székesfehérvár, Hungary
- Investigational Site Number : 3800004 — Milan, Milano, Italy
- Investigational Site Number : 3800001 — Padua, Padova, Italy
- Investigational Site Number : 3800003 — Rome, Roma, Italy
- Investigational Site Number : 3800002 — Turin, Torino, Italy
- Investigational Site Number : 6160004 — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Investigational Site Number : 6160003 — Warsaw, Masovian Voivodeship, Poland
- Investigational Site Number : 6160002 — Warsaw, Masovian Voivodeship, Poland
- Investigational Site Number : 7520001 — Linköping, Sweden
- Investigational Site Number : 7520002 — Stockholm, Sweden
- Investigational Site Number : 7520003 — Stockholm, Sweden
- Investigational Site Number : 8260002 — Cambridge, Cambridgeshire, United Kingdom
- Investigational Site Number : 8260001 — Oxford, Oxfordshire, United Kingdom
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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