NCT05134441

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,121 (actual)
• Sponsor: Immunic AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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)

Detailed 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

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	IMU-838 tablets	Patients are randomized to IMU-838 or placebo in ratio 1:1
DRUG	Placebo matching IMU-838 tablets	Patients are randomized to IMU-838 or placebo in ratio 1:1

Timeline

• Start date: 2021-11-18
• Primary completion: 2026-11-01
• Completion: 2033-09-01
• First posted: 2021-11-26
• Last updated: 2026-02-23

Locations

91 sites across 16 countries: United States, Albania, Algeria, Bulgaria, Georgia, Germany, India, Jordan, Lebanon, Lithuania, Mexico, Moldova, Montenegro, North Macedonia, Poland, Ukraine

Regulatory

• FDA-regulated drug study