SAR444336: Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Placebo: Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportion of participants with sustained steroid-free clinical remission — up to week 24 Clinical remission defined as no relapse during the 24-week period.
Trial sites (26)
Facility
City
Region
Status
Investigational Site Number : 0560002
Ghent
Belgium
Recruiting
Investigational Site Number : 0560001
Leuven
Belgium
Recruiting
Investigational Site Number : 2080003
Aarhus
Denmark
Recruiting
Investigational Site Number : 2080002
Hvidovre
Denmark
Recruiting
Investigational Site Number : 2500001
Créteil
France
Recruiting
Investigational Site Number : 2500002
Montfermeil
France
Recruiting
Investigational Site Number : 2500003
Pessac
France
Recruiting
Investigational Site Number : 2760001
Frankfurt
Germany
Recruiting
Investigational Site Number : 2760005
Ludwigshafen
Germany
Recruiting
Investigational Site Number : 2760002
Potsdam
Germany
Recruiting
Investigational Site Number : 2760003
Tübingen
Germany
Recruiting
Investigational Site Number : 2760004
Ulm
Germany
Recruiting
Investigational Site Number : 3480002
Budapest
Hungary
Recruiting
Investigational Site Number : 3480003
Székesfehérvár
Hungary
Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Investigational Site Number : 380004
Milan
Milano
Recruiting
Azienda Ospedale Università Padova, Investigational Site Number : 380001
Padua
Padova
Recruiting
Fondazione Policlinico Gemelli IRCCS Roma, Investigational Site Number : 380003
Rome
Roma
Recruiting
A.O.U. Città della Salute e della Scienza di Torino, Presidio Molinette, S.C. Gastroenterologia U., Investigational Site Number : 380002
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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