Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR444336 · 1 trial · 1 indication
Clinical remission defined as no relapse during the 24-week period.
| 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 being developed for microscopic colitis, a gastrointestinal inflammatory condition. Specifically, it is being studied in adults with microscopic colitis who are in clinical remission, with the goal of evaluating efficacy and safety in that population. It is an investigational small molecule and has not been approved for any use.
SAR444336 is being developed by Sanofi, the French pharmaceutical company whose shares trade under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the compound in microscopic colitis.
SAR444336 is in Phase 2 clinical development. The program consists of one active trial, which is currently recruiting participants. No trials for SAR444336 have been completed, and the drug remains investigational rather than approved.
SAR444336 is being evaluated in the Phase 2 trial NCT07156175, titled A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission. The trial is recruiting, plans to enroll 54 adults aged 18 and older, and is randomized, double-blind, and placebo-controlled.
The Phase 2 trial of SAR444336, NCT07156175, is recruiting across nine European countries: Belgium, Denmark, France, Germany, Hungary, Italy, Poland, Sweden, and the United Kingdom. It enrolls adults aged 18 years and older of any sex and does not accept healthy volunteers.