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Evaluating IMU-838 for treating 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-2)

Phase 3 Interventional Immunic AG · NCT05201638

This study is testing a new medication called IMU-838 to see if it can help adults with relapsing multiple sclerosis feel better and manage their symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1050 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorImmunic AG Industry-sponsored
Locations91 sites (Scottsdale, Arizona and 90 other locations)
Trial IDNCT05201638 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to assess the efficacy, safety, and tolerability of IMU-838 in adults diagnosed with relapsing multiple sclerosis (RMS). The study includes a screening period of approximately 28 days, followed by a main treatment period lasting 72 weeks, and an open-label extension period that may last up to 8 years. Participants will receive either IMU-838 or a placebo, and their responses will be monitored throughout the study.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 55 with an established diagnosis of relapsing multiple sclerosis and evidence of active disease.

Not a fit: Patients with non-active secondary progressive multiple sclerosis or primary progressive multiple sclerosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with relapsing multiple sclerosis, potentially improving their quality of life.

How similar studies have performed: Other studies evaluating similar treatments for relapsing multiple sclerosis have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female patient (age ≥18 to ≤55 years).
* Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
* Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014.
* Active disease as defined by Lublin 2014 evidenced prior to Screening by:

  1. At least 2 relapses in the last 24 months before randomization, or
  2. At least 1 relapse in the last 12 months before randomization, or
  3. A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to randomization.
* Willingness and ability to comply with the protocol.
* Written informed consent given prior to any study-related procedure.

Exclusion Criteria:

* Patients with non-active secondary progressive MS and primary progressive MS.
* Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis.
* Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis
* Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease)
* Use of experimental/investigational drug (with the exception of COVID-19 vaccines approved by emergency use authorization) and/or participation in drug clinical studies within 6 months prior to Screening
* Previous or current use of MS treatments lifelong, or within a pre-specified time period.
* Use of the pre-specified concomitant medications.
* Clinically significantly abnormal and pre-specified lab values.
* History of chronic systemic infections within 6 months before the date of informed consent.
* Diagnosis or suspected liver function impairment, which may cause fluctuating liver function tests during this study.
* Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis.
* History or clinical diagnosis of gout.
* History or presence of any major medical or psychiatric illness
* Substantial medical condition that could create undue risk to the patient, could affect adherence with the study protocol or could undesirably affect study outcomes

Where this trial is running

Scottsdale, Arizona and 90 other locations

+41 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Sclerosis, Relapsing-Remitting
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.