Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07156175 | A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission | PHASE2 | RECRUITING | 54 | — | — | Oct 14, 2025 | May 6, 2027 | Feb 24, 2026 | 26 | Belgium, Denmark +7 |
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...