Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

Phase 3 Active not recruiting 1121 enrolled Immunic AG

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1)

Timeline

Start: 2021-11-18
Primary completion: 2026-11
Completion: 2033-09

Publications

Pemba CM, Sakurai Y, Kurosaki Y, Patten JJ, Amalia E, Inaoka DK, Davey RA, Shiba T, Kita K, Yasuda J. Antiviral activities of ascofuranone and naphthoquinone derivatives against Ebola virus. Antiviral Res. 2026 May;249:106400. doi: 10.1016/j.antiviral.2026.106400. Epub 2026 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vidofludimus	Small molecule	15 mg	Oral
Subject	Vidofludimus	Small molecule	30 mg	Oral

Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

Summary

Timeline

Publications

Drugs

Indications