A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
NCT ID: NCT07156175
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
54 participants
INTERVENTIONAL
2025-10-14
2027-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAR444336
Each participant will receive several injections of SAR444336. Budesonide will be taken at the dose administered by the physician.
SAR444336
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Placebo
Each participant will receive several injections of placebo. Budesonide will be taken at the dose administered by the physician.
Placebo
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Interventions
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SAR444336
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Placebo
Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Investigational Site Number : 2080003
Aarhus, , Denmark
Investigational Site Number : 2080002
Hvidovre, , Denmark
Investigational Site Number : 2500003
Pessac, , France
Investigational Site Number : 3480002
Budapest, , Hungary
Investigational Site Number : 3800001
Padua, Padova, Italy
Investigational Site Number : 3800004
Milan, , Italy
Investigational Site Number : 7520001
Linköping, , Sweden
Investigational Site Number : 7520002
Stockholm, , Sweden
Investigational Site Number : 7520003
Stockholm, , Sweden
Investigational Site Number : 8260002
Cambridge, Cambridgeshire, United Kingdom
Investigational Site Number : 8260001
Oxford, Oxfordshire, United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
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ACT18053 Plain Language Results Summary
Other Identifiers
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2024-519495-83
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1314-5201
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACT18053
Identifier Type: -
Identifier Source: org_study_id