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.
Who can participate
Age range18 Years
SexALL
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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 pr…
What they're measuring
1
Proportion of participants with sustained steroid-free clinical remission
Timeframe: up to week 24
Trial details
NCT IDNCT07156175
SponsorSanofi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-04-08
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)