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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (2 UK sites)
Investigational Site Number : 8260002
Cambridge CB2 2QQ, United Kingdom
Investigational Site Number : 8260001
Oxford OX3 9DU, United Kingdom
How to Get in Touch
Trial Transparency email recommended (Toll free for US & Canada)
Sponsor contactCONTACT
