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

Last updated: February 20, 2026
Sponsor: Immunic AG
Overall Status: Active - Not Recruiting

Phase

3

Condition

Neurologic Disorders

Multiple Sclerosis

Memory Loss

Treatment

Placebo matching IMU-838 tablets

IMU-838 tablets

Clinical Study ID

NCT05134441
P3-IMU-838-RMS-01
  • Ages 18-55
  • All Genders

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)

Eligibility Criteria

Inclusion

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 secondaryprogressive 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 torandomization.

  • Willingness and ability to comply with the protocol.

  • Written informed consent given prior to any study-related procedure.

Exclusion

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, includinghistory of complete transverse myelitis.

  • Clinical signs or presence of laboratory findings suggestive for neuromyelitisoptica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis

  • Any active and uncontrolled coexisting autoimmune disease, other than MS (except fortype 1 diabetes mellitus and inflammatory bowel disease)

  • Use of experimental/investigational drug (with the exception ofCOVID-19 vaccinesapproved by emergency use authorization) and/or participation in drug clinicalstudies within 6 months prior to Screening

  • Previous or current use of MS treatments lifelong, or within a pre-specified timeperiod.

  • 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 informedconsent.

  • Diagnosis or suspected liver function impairment, which may cause fluctuating liverfunction tests during this study.

  • Known history of nephrolithiasis or underlying condition with a strong associationof 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, couldaffect adherence with the study protocol or could undesirably affect study outcomes

Study Design

Total Participants: 1121
Treatment Group(s): 2
Primary Treatment: Placebo matching IMU-838 tablets
Phase: 3
Study Start date:
November 18, 2021
Estimated Completion Date:
September 30, 2033

Study 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

Connect with a study center

  • Hygeia Hospital Tirana

    Tirana,
    Albania

    Site Not Available

  • Klinika Mjekesore Nuova, Neurology Clinic

    Tirana, 1005
    Albania

    Active - Recruiting

  • Hygeia Hospital Tirana

    Tirana 3183875,
    Albania

    Site Not Available

  • Klinika Mjekesore Nuova, Neurology Clinic

    Tirana 3183875, 1005
    Albania

    Site Not Available

  • University Hospital Center Mustapha Pacha, Algiers

    Algiers 2507480, 16000
    Algeria

    Site Not Available

  • University Hospital Center Ibn Sina, Annaba

    Annaba 2506999, 23000
    Algeria

    Site Not Available

  • University Hospital Center of Oran

    Oran 2485926, 31000
    Algeria

    Site Not Available

  • MHAT Puls AD

    Blagoevgrad, 2700
    Bulgaria

    Site Not Available

  • MHAT Puls AD

    Blagoevgrad 733191, 2700
    Bulgaria

    Site Not Available

  • MHAT "Heart and Brain", EAD

    Burgas, 8000
    Bulgaria

    Site Not Available

  • MHAT "Heart and Brain", EAD

    Burgas 732770, 8000
    Bulgaria

    Site Not Available

  • Heart and Brain University Hospital

    Pleven,
    Bulgaria

    Active - Recruiting

  • MC Exacta Medica OOD

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • MC Vita 1

    Pleven,
    Bulgaria

    Active - Recruiting

  • MHAT Avis Medica

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • UMHAT Dr.Georgi Stranski EAD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Heart and Brain University Hospital

    Pleven 728203,
    Bulgaria

    Site Not Available

  • MC Exacta Medica OOD

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • MC Vita 1

    Pleven 728203,
    Bulgaria

    Site Not Available

  • MHAT Avis Medica

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • UMHAT Dr.Georgi Stranski EAD

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • UMHAT Sveti Georgi

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • UMHAT "Kaspela"EOOD

    Plovdiv 728193, 4001
    Bulgaria

    Site Not Available

  • UMHAT "Pulmed" Ltd

    Plovdiv 728193, 4002
    Bulgaria

    Site Not Available

  • UMHAT Sveti Georgi

    Plovdiv 728193, 4002
    Bulgaria

    Site Not Available

  • UMHAT "Medica Ruse"

    Rousse 727523,
    Bulgaria

    Site Not Available

  • UMHAT "Medica Ruse"

    Ruse,
    Bulgaria

    Site Not Available

  • CCB Medical Institute Ministry of Interior

    Sofia, 1000
    Bulgaria

    Active - Recruiting

  • Diagnostic and Consultative Center Neoclinic

    Sofia, 1000
    Bulgaria

    Active - Recruiting

  • MHAT "Sveta Sofia" EOOD

    Sofia, 1618
    Bulgaria

    Active - Recruiting

  • MHATNP "Sveti Naum", EAD

    Sofia, 1113
    Bulgaria

    Active - Recruiting

  • MHATNPsy Sveti Naum EAD

    Sofia, 1113
    Bulgaria

    Active - Recruiting

  • Military Medical Academy

    Sofia,
    Bulgaria

    Active - Recruiting

  • Military Medical Academy MHAT

    Sofia, 1606
    Bulgaria

    Active - Recruiting

  • UMHAT "Alexandrovska"

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • UMHAT "Alexandrovska" EAD

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • UMHAT "Sveti Ivan Rilski" EAD

    Sofia, 1000
    Bulgaria

    Active - Recruiting

  • UMHAT"Tsaritsa Yoanna -ISUL

    Sofia,
    Bulgaria

    Site Not Available

  • UMHATEM N.Pirogov

    Sofia,
    Bulgaria

    Active - Recruiting

  • CCB Medical Institute Ministry of Interior

    Sofia 727011, 1000
    Bulgaria

    Site Not Available

  • Diagnostic and Consultative Center Neoclinic

    Sofia 727011, 1000
    Bulgaria

    Site Not Available

  • MHAT "Sveta Sofia" EOOD

    Sofia 727011, 1618
    Bulgaria

    Site Not Available

  • MHATNP "Sveti Naum", EAD

    Sofia 727011, 1113
    Bulgaria

    Site Not Available

  • MHATNPsy Sveti Naum EAD

    Sofia 727011, 1113
    Bulgaria

    Site Not Available

  • Military Medical Academy

    Sofia 727011,
    Bulgaria

    Site Not Available

  • Military Medical Academy MHAT

    Sofia 727011, 1606
    Bulgaria

    Site Not Available

  • UMHAT "Alexandrovska"

    Sofia 727011, 1431
    Bulgaria

    Site Not Available

  • UMHAT "Alexandrovska" EAD

    Sofia 727011, 1431
    Bulgaria

    Site Not Available

  • UMHAT "Sveti Ivan Rilski" EAD

    Sofia 727011, 1000
    Bulgaria

    Site Not Available

  • UMHAT"Tsaritsa Yoanna -ISUL

    Sofia 727011,
    Bulgaria

    Site Not Available

  • UMHATEM N.Pirogov

    Sofia 727011,
    Bulgaria

    Site Not Available

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

    Varna,
    Bulgaria

    Site Not Available

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

    Varna 726050,
    Bulgaria

    Site Not Available

  • Clínica Colsanitas S.A. Sede Clínica Universitaria Colombia

    Bogotá,
    Colombia

    Site Not Available

  • Neurocountry Portoazul S.A.S.

    Puerto Colombia,
    Colombia

    Site Not Available

  • 1st Uni Clinic of Tbilisi LEPL

    Tbilisi, 0141
    Georgia

    Active - Recruiting

  • Eristavi Experimental Center

    Tbilisi,
    Georgia

    Active - Recruiting

  • J.S.C. Curatio Clinic

    Tbilisi,
    Georgia

    Active - Recruiting

  • Katsiashvili Emergency Center

    Tbilisi,
    Georgia

    Active - Recruiting

  • Khechinashvili University Hospital

    Tbilisi,
    Georgia

    Active - Recruiting

  • LTD Aversi Clinic

    Tbilisi,
    Georgia

    Active - Recruiting

  • LTD New Hospitals

    Tbilisi,
    Georgia

    Site Not Available

  • MediClub Georgia LLC

    Tbilisi,
    Georgia

    Active - Recruiting

  • Pineo Medical Ecosystem LTD

    Tbilisi,
    Georgia

    Active - Recruiting

  • Sarajishvili Neurology Institute

    Tbilisi,
    Georgia

    Active - Recruiting

  • 1st Uni Clinic of Tbilisi LEPL

    Tbilisi 611717, 0141
    Georgia

    Site Not Available

  • Eristavi Experimental Center

    Tbilisi 611717,
    Georgia

    Site Not Available

  • J.S.C. Curatio Clinic

    Tbilisi 611717,
    Georgia

    Site Not Available

  • Katsiashvili Emergency Center

    Tbilisi 611717,
    Georgia

    Site Not Available

  • Khechinashvili University Hospital

    Tbilisi 611717,
    Georgia

    Site Not Available

  • LTD Aversi Clinic

    Tbilisi 611717,
    Georgia

    Site Not Available

  • LTD New Hospitals

    Tbilisi 611717,
    Georgia

    Site Not Available

  • MediClub Georgia LLC

    Tbilisi 611717,
    Georgia

    Site Not Available

  • Pineo Medical Ecosystem LTD

    Tbilisi 611717,
    Georgia

    Site Not Available

  • Sarajishvili Neurology Institute

    Tbilisi 611717,
    Georgia

    Site Not Available

  • University Hospital Muenster, Institute Translational Neurology dept. Neurology

    Münster 2867543, 48149
    Germany

    Site Not Available

  • Athens Medical Center

    Athens,
    Greece

    Site Not Available

  • Thessaloniki Hosptl

    Thessaloníki,
    Greece

    Site Not Available

  • Medstar Speciality Hospital

    Bangalore 1277333, 560092
    India

    Site Not Available

  • Kanoria Hospital & Research Centre

    Gandhinagar, 382428
    India

    Site Not Available

  • Mallikatte, Kadri

    Mangalore, 575002
    India

    Site Not Available

  • Mallikatte, Kadri

    Mangalore 1263780, 575002
    India

    Site Not Available

  • Jasleen Hospital

    Nagpur,
    India

    Site Not Available

  • Jasleen Hospital

    Nagpur 1262180,
    India

    Site Not Available

  • Sir Ganga Ram Hospital

    New Delhi, 110060
    India

    Site Not Available

  • Sir Ganga Ram Hospital

    New Delhi 1261481, 110060
    India

    Site Not Available

  • Ruby Hospital

    Pune, 411001
    India

    Site Not Available

  • Ruby Hospital

    Pune 1259229, 411001
    India

    Site Not Available

  • Indira Gandhi Medical College & Hospital

    Shimla, 171001
    India

    Site Not Available

  • Indira Gandhi Medical College & Hospital

    Shimla 1256237, 171001
    India

    Site Not Available

  • Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi

    Varanasi, 221005
    India

    Site Not Available

  • Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi

    Varanasi 1253405, 221005
    India

    Site Not Available

  • TSH Advanced Clinical Center

    Amman,
    Jordan

    Site Not Available

  • Istiklal Hospital

    Amman 250441, 11196
    Jordan

    Site Not Available

  • Jordan University Hospital

    Amman 250441, 11942
    Jordan

    Site Not Available

  • TSH Advanced Clinical Center

    Amman 250441,
    Jordan

    Site Not Available

  • Irbid Speciality Hospital

    Irbid,
    Jordan

    Site Not Available

  • Irbid Speciality Hospital

    Irbid 248946,
    Jordan

    Site Not Available

  • Hotel Dieu de France Hospital

    Beirut,
    Lebanon

    Site Not Available

  • Hotel Dieu de France Hospital

    Beirut 276781,
    Lebanon

    Site Not Available

  • AUB Medical Center

    Hamra, 1107-2020
    Lebanon

    Site Not Available

  • AUB Medical Center

    Hamra 6274905, 1107-2020
    Lebanon

    Site Not Available

  • Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos

    Kaunas, 50161
    Lithuania

    Site Not Available

  • Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos

    Kaunas 598316, 50161
    Lithuania

    Site Not Available

  • Klaipedos Universitetine Ligonine - Klaipedos Issetines Sklerozes Centra

    Klaipėda, 92288
    Lithuania

    Site Not Available

  • Neurociencias Estudios Clínicos S.C

    Culiacán, 80020
    Mexico

    Site Not Available

  • Neurociencias Estudios Clínicos S.C

    Culiacán 4012176, 80020
    Mexico

    Site Not Available

  • Instituto Jalisciense de Metabolismo, SC

    Guadalajara, 44670
    Mexico

    Site Not Available

  • Instituto Jalisciense de Metabolismo, SC

    Guadalajara 4005539, 44670
    Mexico

    Site Not Available

  • Cliditer S.A de C.V

    Mexico City, 06700
    Mexico

    Active - Recruiting

  • Clinstile SA de CV

    Mexico City,
    Mexico

    Site Not Available

  • Grupo medico camino SC

    Mexico City, 03310
    Mexico

    Active - Recruiting

  • Unidad de Investigación en Salud de Chihuahua S.C.

    Mexico City, 14050
    Mexico

    Active - Recruiting

  • Cliditer S.A de C.V

    Mexico City 3530597, 06700
    Mexico

    Site Not Available

  • Clinstile SA de CV

    Mexico City 3530597,
    Mexico

    Site Not Available

  • Grupo medico camino SC

    Mexico City 3530597, 03310
    Mexico

    Site Not Available

  • Unidad de Investigación en Salud de Chihuahua S.C.

    Mexico City 3530597, 14050
    Mexico

    Site Not Available

  • Centro de Morelia

    Morelia, 58000
    Mexico

    Site Not Available

  • Centro de Morelia

    Morelia 3995402, 58000
    Mexico

    Site Not Available

  • Faicic de RL de CV

    Veracruz, 91900
    Mexico

    Site Not Available

  • Sociedad de Metabolismo y Corazon, S.C.

    Veracruz, 91900
    Mexico

    Active - Recruiting

  • Faicic de RL de CV

    Veracruz 3514783, 91900
    Mexico

    Site Not Available

  • Sociedad de Metabolismo y Corazon, S.C.

    Veracruz 3514783, 91900
    Mexico

    Site Not Available

  • Instititute of Emergency Medicine

    Chisinau 618426,
    Moldova

    Site Not Available

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

    Chisinau 618426,
    Moldova

    Site Not Available

  • The Diomid Gherman Institute of Neurology and Neurosurgery

    Chisinau 618426,
    Moldova

    Site Not Available

  • Instititute of Emergency Medicine

    Chisinau,
    Moldova, Republic of

    Active - Recruiting

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

    Chisinau,
    Moldova, Republic of

    Site Not Available

  • The Diomid Gherman Institute of Neurology and Neurosurgery

    Chisinau,
    Moldova, Republic of

    Active - Recruiting

  • General Hospital Niksic

    Nikšić,
    Montenegro

    Site Not Available

  • General Hospital Niksic

    Nikšić 3194494,
    Montenegro

    Site Not Available

  • Clinical Center of Montenegro

    Podgorica,
    Montenegro

    Site Not Available

  • Clinical Center of Montenegro

    Podgorica 3193044,
    Montenegro

    Site Not Available

  • Hospital "8 mi Septemvri"

    Skopje,
    North Macedonia

    Site Not Available

  • University Clinic of Neurology

    Skopje,
    North Macedonia

    Active - Recruiting

  • Hospital "8 mi Septemvri"

    Skopje 785842,
    North Macedonia

    Site Not Available

  • University Clinic of Neurology

    Skopje 785842,
    North Macedonia

    Site Not Available

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

    Lublin 765876, 20-064
    Poland

    Site Not Available

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

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

    Chernihiv 710735, 14029
    Ukraine

    Site Not Available

  • Chernihiv Regional Hospital

    Chernivtsi,
    Ukraine

    Site Not Available

  • Chernihiv Regional Hospital

    Chernivtsi 710719,
    Ukraine

    Site Not Available

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

    Chernivtsi 710719, 58023
    Ukraine

    Site Not Available

  • Neuro Global, LLC

    Ivano-Frankivs'k, 76493
    Ukraine

    Site Not Available

  • Regional Clinical Hospital

    Ivano-Frankivs'k, 76008
    Ukraine

    Active - Recruiting

  • Neuro Global, LLC

    Ivano-Frankivsk 707471, 76493
    Ukraine

    Site Not Available

  • Regional Clinical Hospital

    Ivano-Frankivsk 707471, 76008
    Ukraine

    Site Not Available

  • Khmelnytsky regional hospital of war veterans

    Khmelnytskyi,
    Ukraine

    Site Not Available

  • Khmelnytsky regional hospital of war veterans

    Khmelnytskyi 706369,
    Ukraine

    Site Not Available

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

    Kiev,
    Ukraine

    Site Not Available

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

    Kiev 703448,
    Ukraine

    Site Not Available

  • Kyiv City Hospital 4

    Kiew,
    Ukraine

    Site Not Available

  • "Medbud"

    Kyiv, 3037
    Ukraine

    Site Not Available

  • SMART medical center

    Kyiv, 4212
    Ukraine

    Site Not Available

  • "Medbud"

    Kyiv 703448, 3037
    Ukraine

    Site Not Available

  • Kyiv City Hospital 4

    Kyiv 703448,
    Ukraine

    Site Not Available

  • SMART medical center

    Kyiv 703448, 4212
    Ukraine

    Site Not Available

  • Odesa Regional Clinical Hospital, Department of Neurosurgery

    Odesa,
    Ukraine

    Site Not Available

  • Odesa Regional Clinical Hospital, Department of Neurosurgery

    Odesa 698740,
    Ukraine

    Site Not Available

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

    Poltava,
    Ukraine

    Site Not Available

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

    Poltava 696643,
    Ukraine

    Site Not Available

  • Ternopil Psycho-Neuro Hospital

    Ternopil 691650, 46027
    Ukraine

    Site Not Available

  • Ternopil Psycho-Neuro Hospital

    Ternopil', 46027
    Ukraine

    Site Not Available

  • Regional Clinical Center for Neurosurgery and Neurology

    Uzhhorod,
    Ukraine

    Site Not Available

  • Regional Clinical Center for Neurosurgery and Neurology

    Uzhhorod 690548,
    Ukraine

    Site Not Available

  • Xenoscience, Inc., 21st Century Neurology

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Xenoscience, Inc., 21st Century Neurology

    Phoenix 5308655, Arizona 5551752 85004
    United States

    Site Not Available

  • Regina Berkovich MD, PhD Inc. MS Neurology

    West Hollywood 5408076, California 5332921 90048
    United States

    Site Not Available

  • Bradenton Research Center

    Bradenton, Florida 34205
    United States

    Site Not Available

  • Reliant Medical Research, LLC

    Miami, Florida 33165
    United States

    Site Not Available

  • Collier Neurologic Specialists

    Naples, Florida 34105
    United States

    Site Not Available

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Bradenton Research Center

    Bradenton 4148708, Florida 4155751 34205
    United States

    Site Not Available

  • Collier Neurologic Specialists

    Naples 4165565, Florida 4155751 34105
    United States

    Site Not Available

  • Neurology Associates of Ormond Beach

    Ormond Beach 4167178, Florida 4155751 32174
    United States

    Site Not Available

  • Consultants in Neurology, Ltd

    Northbrook, Illinois 60062
    United States

    Site Not Available

  • Consultants in Neurology, Ltd

    Northbrook 4904056, Illinois 4896861 60062
    United States

    Site Not Available

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