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Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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)

NCT05134441•Immunic AG

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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 ofCOVID-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.
+4 more criteria

Locations (91)

Xenoscience, Inc., 21st Century Neurology

Phoenix, Arizona, United States

Regina Berkovich MD, PhD Inc. MS Neurology

West Hollywood, California, United States

Bradenton Research Center

Bradenton, Florida, United States

Collier Neurologic Specialists

Naples, Florida, United States

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States

Consultants in Neurology, Ltd

Northbrook, Illinois, United States

Klinika Mjekesore Nuova, Neurology Clinic

Tirana, Albania

Hygeia Hospital Tirana

Tirana, Albania

University Hospital Center Mustapha Pacha, Algiers

Algiers, Algeria

University Hospital Center Ibn Sina, Annaba

Annaba, Algeria

Key Dates

Start Date

November 18, 2021

Primary Completion Date

November 1, 2026

Completion Date

September 1, 2033

Last Updated

February 23, 2026

Enrollment

1,121

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

IMU-838 tablets

DRUG

Placebo matching IMU-838 tablets

DRUG

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

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