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

NCT05134441 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1121

Last updated 2026-02-23

No results posted yet for this study

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)

Conditions

Interventions

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

Sponsors & Collaborators

  • Immunic AG

    lead INDUSTRY

Principal Investigators

  • Robert J. Fox, MD · Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2026-11-30
Completion
2033-09-30
FDA Drug
Yes

Countries

  • United States
  • Albania
  • Algeria
  • Bulgaria
  • Georgia
  • Germany
  • India
  • Jordan
  • Lebanon
  • Lithuania
  • Mexico
  • Moldova
  • Montenegro
  • North Macedonia
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05134441 on ClinicalTrials.gov