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Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis — ENSURE-1  

Multiple Sclerosis Clinical Trial

Official title:
A 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)

Clinical Trial 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)

Clinical Trial Description

This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU-838 in adult patients with RMS. The study will consist of the following periods: Screening Period: Approximately 28 days Main Treatment Period: Up to 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05134441
Study type Interventional
Source Immunic AG
Contact Andreas Muehler, MD
Phone +49 89 2080 477 00
Email info@imux.com
Status Recruiting
Phase Phase 3
Start date November 18, 2021
Completion date September 2032
View Details
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