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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05134441 | Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | PHASE3 | ACTIVE NOT_RECRUITING | 1,121 | — | — | Nov 18, 2021 | Sep 1, 2033 | Feb 23, 2026 | 91 | United States, Albania +14 |
Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks.
| Arm | Type | Description |
|---|---|---|
| IMU-838 | EXPERIMENTAL | IMU-838 (vidofludimus calcium), a small molecule inhibitor of DHODH. Formulation: Tablets with 15 or 30 mg IMU-838 for once daily oral intake in the morning. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, as described for the test product, identical number of tablets as given for IMU-838. |
| Name | Type | Description |
|---|---|---|
| IMU-838 tablets | DRUG | Patients are randomized to IMU-838 or placebo in ratio 1:1 |
| Placebo matching IMU-838 tablets | DRUG | Patients are randomized to IMU-838 or placebo in ratio 1:1 |
Inclusion Criteria: * Male or female patient (age ≥18 to ≤55 years). * Patients with an established diagnosis of MS according to 2017 McDonald Criteria. * Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 199...