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

Last updated: April 17, 2024
Sponsor: Immunic AG
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Sclerosis

Neurologic Disorders

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 neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associatedencephalomyelitis
  • 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 clinical studieswithin 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 association ofnephrolithiasis.
  • 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: 1050
Treatment Group(s): 2
Primary Treatment: Placebo matching IMU-838 tablets
Phase: 3
Study Start date:
November 18, 2021
Estimated Completion Date:
September 30, 2032

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

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  • Klinika Mjekesore Nuova, Neurology Clinic

    Tirana, 1005
    Albania

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  • MHAT Puls AD

    Blagoevgrad, 2700
    Bulgaria

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  • MHAT "Heart and Brain", EAD

    Burgas, 8000
    Bulgaria

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  • Heart and Brain University Hospital

    Pleven,
    Bulgaria

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  • MC Exacta Medica OOD

    Pleven, 5800
    Bulgaria

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  • MC Vita 1

    Pleven,
    Bulgaria

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  • MHAT Avis Medica

    Pleven, 5800
    Bulgaria

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  • UMHAT Dr.Georgi Stranski EAD

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • UMHAT Sveti Georgi

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • UMHAT "Medica Ruse"

    Ruse,
    Bulgaria

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  • CCB Medical Institute Ministry of Interior

    Sofia, 1000
    Bulgaria

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  • Diagnostic and Consultative Center Neoclinic

    Sofia, 1000
    Bulgaria

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  • MHAT "Sveta Sofia" EOOD

    Sofia, 1618
    Bulgaria

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  • MHATNP "Sveti Naum", EAD

    Sofia, 1113
    Bulgaria

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  • MHATNPsy Sveti Naum EAD

    Sofia, 1113
    Bulgaria

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  • Military Medical Academy

    Sofia,
    Bulgaria

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  • Military Medical Academy MHAT

    Sofia, 1606
    Bulgaria

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  • UMHAT "Alexandrovska"

    Sofia, 1431
    Bulgaria

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  • UMHAT "Alexandrovska" EAD

    Sofia, 1431
    Bulgaria

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  • UMHAT "Sveti Ivan Rilski" EAD

    Sofia, 1000
    Bulgaria

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  • UMHAT"Tsaritsa Yoanna -ISUL

    Sofia,
    Bulgaria

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  • UMHATEM N.Pirogov

    Sofia,
    Bulgaria

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

    Varna,
    Bulgaria

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  • Clínica Colsanitas S.A. Sede Clínica Universitaria Colombia

    Bogotá,
    Colombia

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  • Neurocountry Portoazul S.A.S.

    Puerto Colombia,
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  • 1st Uni Clinic of Tbilisi LEPL

    Tbilisi, 0141
    Georgia

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  • Eristavi Experimental Center

    Tbilisi,
    Georgia

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  • J.S.C. Curatio Clinic

    Tbilisi,
    Georgia

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  • Katsiashvili Emergency Center

    Tbilisi,
    Georgia

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  • Khechinashvili University Hospital

    Tbilisi,
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  • LTD Aversi Clinic

    Tbilisi,
    Georgia

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  • LTD New Hospitals

    Tbilisi,
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  • MediClub Georgia LLC

    Tbilisi,
    Georgia

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  • Pineo Medical Ecosystem LTD

    Tbilisi,
    Georgia

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  • Sarajishvili Neurology Institute

    Tbilisi,
    Georgia

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  • Athens Medical Center

    Athens,
    Greece

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  • Thessaloniki Hosptl

    Thessaloníki,
    Greece

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  • Kanoria Hospital & Research Centre

    Gandhinagar, 382428
    India

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  • Mallikatte, Kadri

    Mangalore, 575002
    India

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  • Jasleen Hospital

    Nagpur,
    India

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  • Sir Ganga Ram Hospital

    New Delhi, 110060
    India

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  • Ruby Hospital

    Pune, 411001
    India

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  • Indira Gandhi Medical College & Hospital

    Shimla, 171001
    India

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

    Varanasi, 221005
    India

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  • TSH Advanced Clinical Center

    Amman,
    Jordan

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  • Irbid Speciality Hospital

    Irbid,
    Jordan

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  • Hotel Dieu de France Hospital

    Beirut,
    Lebanon

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  • AUB Medical Center

    Hamra, 1107-2020
    Lebanon

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  • Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos

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    Lithuania

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  • Klaipedos Universitetine Ligonine - Klaipedos Issetines Sklerozes Centra

    Klaipėda, 92288
    Lithuania

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  • Neurociencias Estudios Clínicos S.C

    Culiacán, 80020
    Mexico

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  • Instituto Jalisciense de Metabolismo, SC

    Guadalajara, 44670
    Mexico

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  • Cliditer S.A de C.V

    Mexico City, 06700
    Mexico

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  • Clinstile SA de CV

    Mexico City,
    Mexico

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  • Grupo medico camino SC

    Mexico City, 03310
    Mexico

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

    Mexico City, 14050
    Mexico

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  • Centro de Morelia

    Morelia, 58000
    Mexico

    Active - Recruiting

  • Faicic de RL de CV

    Veracruz, 91900
    Mexico

    Active - Recruiting

  • Sociedad de Metabolismo y Corazon, S.C.

    Veracruz, 91900
    Mexico

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  • Instititute of Emergency Medicine

    Chisinau,
    Moldova, Republic of

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

    Chisinau,
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  • The Diomid Gherman Institute of Neurology and Neurosurgery

    Chisinau,
    Moldova, Republic of

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  • General Hospital Niksic

    Nikšić,
    Montenegro

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  • Clinical Center of Montenegro

    Podgorica,
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  • Hospital "8 mi Septemvri"

    Skopje,
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  • University Clinic of Neurology

    Skopje,
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  • Hospital Universitario La Paz

    Madrid,
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  • Chernihiv Regional Hospital

    Chernivtsi,
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  • Neuro Global, LLC

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  • Khmelnytsky regional hospital of war veterans

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

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  • Kyiv City Hospital 4

    Kiew,
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  • "Medbud"

    Kyiv, 3037
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    Site Not Available

  • SMART medical center

    Kyiv, 4212
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    Site Not Available

  • Odesa Regional Clinical Hospital, Department of Neurosurgery

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

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  • Ternopil Psycho-Neuro Hospital

    Ternopil', 46027
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  • Regional Clinical Center for Neurosurgery and Neurology

    Uzhhorod,
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  • Xenoscience, Inc., 21st Century Neurology

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  • Bradenton Research Center

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  • Reliant Medical Research, LLC

    Miami, Florida 33165
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    Site Not Available

  • Collier Neurologic Specialists

    Naples, Florida 34105
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  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida 32174
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  • Consultants in Neurology, Ltd

    Northbrook, Illinois 60062
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    Active - Recruiting

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