MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS)

• Status: Active, not recruiting
• Trial end date: 2029-12-01

Summary

This is a Phase 2 multicenter, double-blind, placebo-controlled, randomized, parallel-group trial to assess the efficacy and safety of 2 once-daily oral doses of IMU-838 (vidofludimus calcium), a small molecule inhibitor of dihydroorotate dehydrogenase (DHODH), 30 mg/day and 45 mg/day, in patients with RRMS and evidence of active disease.

The trial consists of a screening period, a blinded 24-week main treatment period, and an optional initially blinded, then open-label extended treatment period of up to 9.5 years.

About 40 centers are planned to participate in Romania, Bulgaria, Ukraine, and Poland; potential additional centers in Hungary and Croatia. In total, 195 patients are planned to be randomized 1:1:1 to treatment with 30 mg/day or 45 mg/day IMU-838, or placebo (65 patients each) in the main treatment period. During the extended treatment period, patients will be re-randomized such that patients previously on placebo will be re-randomized 1:1 to treatment with 30 g/day or 45 mg/day IMU-838, all other patients will be re-randomized to the same treatment they previously received.

• Phase: Phase 2

Details

• Lead Sponsor: Immunic AG
• Treatments: Calcium; Calcium, Dietary