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Looking for participantsPhase2

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

Sponsor: Sanofi

NCT ID: NCT07156175

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
SAR444336 (drug), Placebo (drug)
How long the study runs
Study runs about 19 months (dates as stated)
About the drug or intervention
SAR444336 — drug: Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous · Placebo — drug: Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
54
Started
2025-10-14
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for microscopic colitis
  • • Phase2 - 54 participants
  • • This is a parallel, placebo-controlled, multicenter, randomized, double-blind, Phase 2, proof of concept study

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with microscopic colitis

Where?

  • • Cambridge - Investigational Site Number : 8260002
  • • Oxford - Investigational Site Number : 8260001

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Microscopic Colitis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

vaccination or positive

Treatment history

Treatments you must have had:

  • ✓ budesonide

What the study is looking for

  • ✓Participants with confirmed by a biopsy 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.

Who cannot take part

  • ✗Significant neutrophilic/eosinophilic infiltration, crypt abscesses, granulomata, or any evidence of IBD other than...
  • ✗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...
  • ✗Any current active viral, bacterial, or fungal infection or any medically relevant infection having occurred within...
  • ✗Previous bowel surgeries.
See the full 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.

Where Is This Study? (2 UK sites)

Investigational Site Number : 8260002

Cambridge CB2 2QQ, United Kingdom

Recruiting

Investigational Site Number : 8260001

Oxford OX3 9DU, United Kingdom

Recruiting

How to Get in Touch

Trial Transparency email recommended (Toll free for US & Canada)

Sponsor contact

CONTACT

800-633-1610 contact-us@sanofi.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09