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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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)

Key facts

Study ID

NCT05134441

Run by

Immunic AG

People needed

1121

Starts

2021-11-18

Expected to finish

2033-09-01

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• At least 2 relapses in the last 24 months before randomization, or
• At least 1 relapse in the last 12 months before randomization, or
• 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.

You may not qualify if…

• 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.
• 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 it is running

• 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
• University Hospital Center of Oran — Oran, Algeria
• MHAT Puls AD — Blagoevgrad, Bulgaria
• MHAT "Heart and Brain", EAD — Burgas, Bulgaria
• MC Exacta Medica OOD — Pleven, Bulgaria
• MHAT Avis Medica — Pleven, Bulgaria
• UMHAT Dr.Georgi Stranski EAD — Pleven, Bulgaria
• Heart and Brain University Hospital — Pleven, Bulgaria
• MC Vita 1 — Pleven, Bulgaria
• UMHAT "Kaspela"EOOD — Plovdiv, Bulgaria
• UMHAT "Pulmed" Ltd — Plovdiv, Bulgaria
• UMHAT Sveti Georgi — Plovdiv, Bulgaria
• UMHAT "Medica Ruse" — Rousse, Bulgaria
• CCB Medical Institute Ministry of Interior — Sofia, Bulgaria
• Diagnostic and Consultative Center Neoclinic — Sofia, Bulgaria
• UMHAT "Sveti Ivan Rilski" EAD — Sofia, Bulgaria
• Xenoscience, Inc., 21st Century Neurology — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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