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SAR444336 · 2 trials · 2 indications
Clinical remission defined as no relapse during the 24-week period.
Clinical laboratory evaluations including eosinophils, procalcitonin, and c-reactive protein (CRP), Vital signs, 12-lead electrocardiogram (ECG)
Clinical laboratory evaluations including eosinophils, procalcitonin, and c-reactive protein (CRP), Vital signs, 12-lead electrocardiogram (ECG)
| Arm | Type | Description |
|---|---|---|
| SAR444336 | EXPERIMENTAL | Each participant will receive several injections of SAR444336. Budesonide will be taken at the dose administered by the physician. |
| Placebo | PLACEBO_COMPARATOR | Each participant will receive several injections of placebo. Budesonide will be taken at the dose administered by the physician. |
| Name | Type | Description |
|---|---|---|
| SAR444336 | DRUG | Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous |
| Placebo | DRUG | Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous |
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 prio...
SAR444336 is an investigational small molecule being studied for microscopic colitis, a chronic inflammatory bowel condition. It is also being evaluated in healthy volunteers to assess its tolerability, pharmacokinetics, and pharmacodynamics. The drug is currently in clinical development and is not approved for any use.
SAR444336 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational small molecule in healthy volunteers and in patients with microscopic colitis.
SAR444336 is in Phase 1 and Phase 2 clinical development. A Phase 1 study in healthy volunteers has been completed, and a Phase 2 study in adults with microscopic colitis is currently recruiting participants. The drug remains investigational and has not received regulatory approval.
SAR444336 has two clinical trials. NCT05876767 is a completed Phase 1 study in healthy volunteers in the Netherlands, with 76 participants. NCT07156175 is a recruiting Phase 2 study in adults with microscopic colitis in clinical remission, with 54 participants across multiple European countries.
SAR444336 is not FDA approved. It is an investigational drug currently in clinical trials. A Phase 1 study in healthy volunteers has been completed, and a Phase 2 study in microscopic colitis is ongoing. Regulatory approval has not been granted for this drug.