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

NCT05134441 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: P3-IMU-838-RMS-01
• Study Type: interventional
• Target: 1,121
• Locations: 14 countries
• Sites: 85

Brief 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

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse

  Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks.

  72 weeks

Secondary Outcomes (5)

• Effect of IMU-838 versus placebo on volume of new T2 lesions

  72 weeks

• Effect of IMU-838 versus placebo on disability progression

  72 weeks

• Effect of IMU-838 versus placebo on cognitive performance

  72 weeks

• Effect of IMU-838 versus placebo on whole brain atrophy

  72 weeks

• Safety of IMU-838 versus placebo

  72 weeks

Study Arms (2)

IMU-838

EXPERIMENTAL

IMU-838 (vidofludimus calcium), a small molecule inhibitor of DHODH. Formulation: Tablets with 15 or 30 mg IMU-838 for once daily oral intake in the morning.

Drug: IMU-838 tablets

Placebo

PLACEBO COMPARATOR

Matching placebo, as described for the test product, identical number of tablets as given for IMU-838.

Drug: Placebo matching IMU-838 tablets

Interventions

Placebo matching IMU-838 tablets DRUG

Patients are randomized to IMU-838 or placebo in ratio 1:1

Also known as: Placebo matching vidofludimus calcium

Placebo

IMU-838 tablets DRUG

Patients are randomized to IMU-838 or placebo in ratio 1:1

Also known as: vidofludimus calcium

IMU-838

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Immunic AG: lead

Study Sites (91)

Xenoscience, Inc., 21st Century Neurology

Phoenix, Arizona, 85004, United States

Location

Regina Berkovich MD, PhD Inc. MS Neurology

West Hollywood, California, 90048, United States

Location

Bradenton Research Center

Bradenton, Florida, 34205, United States

Location

Collier Neurologic Specialists

Naples, Florida, 34105, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Consultants in Neurology, Ltd

Northbrook, Illinois, 60062, United States

Location

Klinika Mjekesore Nuova, Neurology Clinic

Tirana, 1005, Albania

Location

Hygeia Hospital Tirana

Tirana, Albania

Location

University Hospital Center Mustapha Pacha, Algiers

Algiers, 16000, Algeria

Location

University Hospital Center Ibn Sina, Annaba

Annaba, 23000, Algeria

Location

University Hospital Center of Oran

Oran, 31000, Algeria

Location

MHAT Puls AD

Blagoevgrad, 2700, Bulgaria

Location

MHAT "Heart and Brain", EAD

Burgas, 8000, Bulgaria

Location

MC Exacta Medica OOD

Pleven, 5800, Bulgaria

Location

MHAT Avis Medica

Pleven, 5800, Bulgaria

Location

UMHAT Dr.Georgi Stranski EAD

Pleven, 5800, Bulgaria

Location

Heart and Brain University Hospital

Pleven, Bulgaria

Location

MC Vita 1

Pleven, Bulgaria

Location

UMHAT "Kaspela"EOOD

Plovdiv, 4001, Bulgaria

Location

UMHAT "Pulmed" Ltd

Plovdiv, 4002, Bulgaria

Location

UMHAT Sveti Georgi

Plovdiv, 4002, Bulgaria

Location

UMHAT "Medica Ruse"

Rousse, Bulgaria

Location

CCB Medical Institute Ministry of Interior

Sofia, 1000, Bulgaria

Location

Diagnostic and Consultative Center Neoclinic

Sofia, 1000, Bulgaria

Location

UMHAT "Sveti Ivan Rilski" EAD

Sofia, 1000, Bulgaria

Location

MHATNP "Sveti Naum", EAD

Sofia, 1113, Bulgaria

Location

MHATNPsy Sveti Naum EAD

Sofia, 1113, Bulgaria

Location

UMHAT "Alexandrovska" EAD

Sofia, 1431, Bulgaria

Location

UMHAT "Alexandrovska"

Sofia, 1431, Bulgaria

Location

Military Medical Academy MHAT

Sofia, 1606, Bulgaria

Location

MHAT "Sveta Sofia" EOOD

Sofia, 1618, Bulgaria

Location

Military Medical Academy

Sofia, Bulgaria

Location

UMHAT"Tsaritsa Yoanna -ISUL

Sofia, Bulgaria

Location

UMHATEM N.Pirogov

Sofia, Bulgaria

Location

UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases

Varna, Bulgaria

Location

1st Uni Clinic of Tbilisi LEPL

Tbilisi, 0141, Georgia

Location

Eristavi Experimental Center

Tbilisi, Georgia

Location

J.S.C. Curatio Clinic

Tbilisi, Georgia

Location

Katsiashvili Emergency Center

Tbilisi, Georgia

Location

Khechinashvili University Hospital

Tbilisi, Georgia

Location

LTD Aversi Clinic

Tbilisi, Georgia

Location

LTD New Hospitals

Tbilisi, Georgia

Location

MediClub Georgia LLC

Tbilisi, Georgia

Location

Pineo Medical Ecosystem LTD

Tbilisi, Georgia

Location

Sarajishvili Neurology Institute

Tbilisi, Georgia

Location

University Hospital Muenster, Institute Translational Neurology dept. Neurology

Münster, 48149, Germany

Location

Medstar Speciality Hospital

Bangalore, 560092, India

Location

Mallikatte, Kadri

Mangalore, 575002, India

Location

Jasleen Hospital

Nagpur, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Ruby Hospital

Pune, 411001, India

Location

Indira Gandhi Medical College & Hospital

Shimla, 171001, India

Location

Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi

Varanasi, 221005, India

Location

Istiklal Hospital

Amman, 11196, Jordan

Location

Jordan University Hospital

Amman, 11942, Jordan

Location

TSH Advanced Clinical Center

Amman, Jordan

Location

Irbid Speciality Hospital

Irbid, Jordan

Location

Hotel Dieu de France Hospital

Beirut, Lebanon

Location

AUB Medical Center

Hamra, 1107-2020, Lebanon

Location

Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos

Kaunas, 50161, Lithuania

Location

Neurociencias Estudios Clínicos S.C

Culiacán, 80020, Mexico

Location

Instituto Jalisciense de Metabolismo, SC

Guadalajara, 44670, Mexico

Location

Grupo medico camino SC

Mexico City, 03310, Mexico

Location

Cliditer S.A de C.V

Mexico City, 06700, Mexico

Location

Unidad de Investigación en Salud de Chihuahua S.C.

Mexico City, 14050, Mexico

Location

Clinstile SA de CV

Mexico City, Mexico

Location

Centro de Morelia

Morelia, 58000, Mexico

Location

Faicic de RL de CV

Veracruz, 91900, Mexico

Location

Sociedad de Metabolismo y Corazon, S.C.

Veracruz, 91900, Mexico

Location

Instititute of Emergency Medicine

Chisinau, Moldova

Location

Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery "Diomid Gherman"

Chisinau, Moldova

Location

The Diomid Gherman Institute of Neurology and Neurosurgery

Chisinau, Moldova

Location

General Hospital Niksic

Nikšić, Montenegro

Location

Clinical Center of Montenegro

Podgorica, Montenegro

Location

Hospital "8 mi Septemvri"

Skopje, North Macedonia

Location

University Clinic of Neurology

Skopje, North Macedonia

Location

NZOZ Neuromed M. i M. Nastaj Sp. P.

Lublin, 20-064, Poland

Location

Communal Non-Commercial Enterprise "Chernihiv Regional Hospital",Department of Neurology

Chernihiv, 14029, Ukraine

Location

Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital"

Chernivtsi, 58023, Ukraine

Location

Chernihiv Regional Hospital

Chernivtsi, Ukraine

Location

Regional Clinical Hospital

Ivano-Frankivsk, 76008, Ukraine

Location

Neuro Global, LLC

Ivano-Frankivsk, 76493, Ukraine

Location

Khmelnytsky regional hospital of war veterans

Khmelnytskyi, Ukraine

Location

Clinical Hospital #15 of the Podilskyi District of the Kyiv City

Kiev, Ukraine

Location

"Medbud"

Kyiv, 3037, Ukraine

Location

SMART medical center

Kyiv, 4212, Ukraine

Location

Kyiv City Hospital 4

Kyiv, Ukraine

Location

Odesa Regional Clinical Hospital, Department of Neurosurgery

Odesa, Ukraine

Location

Medical and diagnostic center of a LLC "Medcontinent", neurology and rehabilitation center

Poltava, Ukraine

Location

Ternopil Psycho-Neuro Hospital

Ternopil, 46027, Ukraine

Location

Regional Clinical Center for Neurosurgery and Neurology

Uzhhorod, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Robert J. Fox, MD

  Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: November 26, 2021
• Study Start: November 18, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): September 1, 2033
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BU (24); PL (1); GE (10); NO (2); DE (1); ME (9); IN (7); JO (4); LE (2); LI (1); AL (2); UA (14); MO (2); US (6)