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A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
Led by Sanofi · Updated on 2026-02-24
54
Participants Needed
26
Research Sites
81 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Investigational Site Number : 0560002
Ghent, Belgium, 9000
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2
Investigational Site Number : 0560001
Leuven, Belgium, 3000
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3
Investigational Site Number : 2080003
Aarhus, Denmark, 8200
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4
Investigational Site Number : 2080002
Hvidovre, Denmark, 2650
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5
Investigational Site Number : 2500001
Créteil, France, 94010
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6
Investigational Site Number : 2500002
Montfermeil, France, 93370
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7
Investigational Site Number : 2500003
Pessac, France, 33604
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8
Investigational Site Number : 2760001
Frankfurt, Germany, 60389
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9
Investigational Site Number : 2760005
Ludwigshafen, Germany, 67067
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10
Investigational Site Number : 2760002
Potsdam, Germany, 14467
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11
Investigational Site Number : 2760003
Tübingen, Germany, 72076
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12
Investigational Site Number : 2760004
Ulm, Germany, 89081
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13
Investigational Site Number : 3480002
Budapest, Hungary, 1085
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14
Investigational Site Number : 3480003
Székesfehérvár, Hungary, 8000
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15
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Investigational Site Number : 380004
Milan, Milano, Italy, 20122
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16
Azienda Ospedale Università Padova, Investigational Site Number : 380001
Padua, Padova, Italy, 35128
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17
Fondazione Policlinico Gemelli IRCCS Roma, Investigational Site Number : 380003
Rome, Roma, Italy, 00168
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18
A.O.U. Città della Salute e della Scienza di Torino, Presidio Molinette, S.C. Gastroenterologia U., Investigational Site Number : 380002
Turin, Torino, Italy, 10126
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19
Investigational Site Number : 6160004
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-229
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20
Investigational Site Number : 6160003
Warsaw, Masovian Voivodeship, Poland, 00-728
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21
Investigational Site Number : 6160002
Warsaw, Masovian Voivodeship, Poland, 02-507
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22
Investigational Site Number : 7520001
Linköping, Sweden, 581 85
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23
Investigational Site Number : 7520002
Stockholm, Sweden, 113 61
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24
Investigational Site Number : 7520003
Stockholm, Sweden, 116 91
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25
Investigational Site Number : 8260002
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
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26
Investigational Site Number : 8260001
Oxford, Oxfordshire, United Kingdom, OX3 9DU
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Research Team
T
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CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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