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

Memory Loss

Neurologic Disorders

Treatment

Placebo matching IMU-838 tablets

IMU-838 tablets

Clinical Study ID

NCT05201638
P3-IMU-838-RMS-02
  • 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-2)

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 of COVID-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:
January 12, 2022
Estimated Completion Date:
October 31, 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: 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years

Connect with a study center

  • Erebouni Medical Center

    Yerevan, 0087
    Armenia

    Active - Recruiting

  • Heratsi Hospital Complex 1

    Yerevan, 0025
    Armenia

    Active - Recruiting

  • UCC of Rep of Srpska

    Banja Luka,
    Bosnia and Herzegovina

    Active - Recruiting

  • Cantonal Hospital Bihac Dr. Irfan Ljubijankic

    Bihać, 77000
    Bosnia and Herzegovina

    Active - Recruiting

  • University Clinical Center Sarajevo

    Sarajevo, 71000
    Bosnia and Herzegovina

    Active - Recruiting

  • University Clinical Center of Sarajevo

    Sarajevo, 71000
    Bosnia and Herzegovina

    Active - Recruiting

  • University Clinical Center Tuzla

    Tuzla, 75000
    Bosnia and Herzegovina

    Active - Recruiting

  • Astra Clinic

    Tallinn,
    Estonia

    Active - Recruiting

  • Post-Graduation Institute of Medical Education and Research (PGIMER)

    Chandigarh, 160012
    India

    Active - Recruiting

  • Fortis Memorial Research Institute

    Gurugramam, 122002
    India

    Active - Recruiting

  • Dr Ram Manohar Lohia Institute of Medical Sciences

    Lucknow, 226010
    India

    Active - Recruiting

  • All India Institute of Medical Sciences

    New Delhi, 110029
    India

    Active - Recruiting

  • GB Pant Institute of Postgraduate Medical Education and Research

    New Delhi, 110056
    India

    Active - Recruiting

  • SRI Guru Ram Das Institute of Medical Sciences and Research

    Punjabi Bagh, 143006
    India

    Active - Recruiting

  • DKS PGI

    Raipur, 492001
    India

    Active - Recruiting

  • Centro de Investig. Médicas

    Lima, 15801
    Peru

    Active - Recruiting

  • NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"

    Katowice, 40123
    Poland

    Active - Recruiting

  • Neuro-Medic Janusz Zbrojkiewicz

    Katowice, 40686
    Poland

    Active - Recruiting

  • Indywidualna Praktyka Lekarska prof. Konrad Rejdak

    Lublin, 20-410
    Poland

    Active - Recruiting

  • NZOZ Neuromed

    Lublin, 20-064
    Poland

    Active - Recruiting

  • Instytut Zdrowia Boczarska

    Oświęcim, 32-600
    Poland

    Active - Recruiting

  • NZOZ Hertmanowskiej

    Plewiska, 62-064
    Poland

    Active - Recruiting

  • NZOZ Neuro-Kard

    Poznań, 61-853
    Poland

    Active - Recruiting

  • Centrum Medyczne NeuroProtect

    Warsaw, 01684
    Poland

    Active - Recruiting

  • FutureMeds Warszawa Centrum

    Warsaw,
    Poland

    Active - Recruiting

  • Centrum Med. Ibismed

    Zabrze,
    Poland

    Active - Recruiting

  • Elias University Emergency Hospital

    Bucharest, 011461
    Romania

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  • SC Sana Monitoring SRL

    Bucharest, 011025
    Romania

    Active - Recruiting

  • Spitalul clinic CF Constanta

    Constanţa, 900123
    Romania

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  • Asociatia Comunitatea Oamenilor

    Craiova, 200157
    Romania

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  • Clubul Sanatatii SRL

    Câmpulung, 115100
    Romania

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  • Aria Clinic SRL

    Sibiu, 550052
    Romania

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  • Neuro Therapy

    Timişoara, 300425
    Romania

    Site Not Available

  • Spit Jud Branzeu TIM Neuro

    Timişoara, 300723
    Romania

    Active - Recruiting

  • Klinicko bolnicki centar Dr Dragisa Misovic - Dedinje

    Belgrade, 11000
    Serbia

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  • Klinicko bolnicki centar Zvezdara

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Opsta bolnica Medicinski sistem Beograd

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Vojnomedicinska akademija

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Univerzitetski Klinicki centar Kragujevac

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • Univerzitetski Klinicki centar Nis

    Niš, 18000
    Serbia

    Active - Recruiting

  • Hsptl Sveti Vracevi

    Novi Kneževac,
    Serbia

    Active - Recruiting

  • General Hospital Uzice

    Užice, 31000
    Serbia

    Active - Recruiting

  • Klinicko Bolnicki centar Zemun

    Zemun, 11080
    Serbia

    Active - Recruiting

  • Opsta bolnica Djordje Jovanovic Zrenjanin

    Zrenjanin, 23000
    Serbia

    Active - Recruiting

  • Acibadem Adana Hospital

    Adana, 01130
    Turkey

    Active - Recruiting

  • Adana Baskent Hospital

    Adana, 01250
    Turkey

    Active - Recruiting

  • Baskent University Ankara Hospital

    Ankara, 06490
    Turkey

    Active - Recruiting

  • Bezmialem Vakif University Hospital

    Istanbul, 34093
    Turkey

    Active - Recruiting

  • Haydar Pasa Num. EAH

    Istanbul,
    Turkey

    Active - Recruiting

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34899
    Turkey

    Active - Recruiting

  • Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital

    Istanbul, 34785
    Turkey

    Active - Recruiting

  • T.C. Ministry of Health Istanbul Haseki Training and Research Hospital

    Istanbul, 34250
    Turkey

    Active - Recruiting

  • Kocaeli University Research and Application Hospital

    Kocaeli, 41000
    Turkey

    Active - Recruiting

  • T.C. Ministry of Health Kutahya Provincial Directorate of Health Kutahya University of Health Sciences Evliya Celebi Training and Research Hospital

    Kütahya, 43100
    Turkey

    Active - Recruiting

  • Manisa Celal Bayar University Hafsa Sultan Hospital

    Manisa, 45030
    Turkey

    Active - Recruiting

  • 19 Mayis University Medical Faculty Hospital Health Application and Research Center

    Samsun, 55200
    Turkey

    Active - Recruiting

  • Namik Kemal Uni Hospital

    Tekirdağ, 59100
    Turkey

    Active - Recruiting

  • Zonguldak Bulent Ecevit University Health Practice and Research Hospital

    Zonguldak, 67000
    Turkey

    Active - Recruiting

  • Communal noncommercial enterprise "First Cherkasy City Hospital"

    Cherkasy, 18009
    Ukraine

    Site Not Available

  • MS Diagnosis Treatment Center

    Cherkasy,
    Ukraine

    Active - Recruiting

  • Chernihiv City Hospital 4

    Chernihiv,
    Ukraine

    Active - Recruiting

  • "University Clinic" of Dnipro State Medical University, Department of Neurology

    Dnipro, 49038
    Ukraine

    Site Not Available

  • Dnipro City Hospital 6

    Dnipro,
    Ukraine

    Active - Recruiting

  • Municipal Institution "Dnipropetrovsk Regional Rehabilitation Hospital" of Dnipropetrovsk Regional Council"

    Dnipro, 49000
    Ukraine

    Active - Recruiting

  • Ukrainian State Research Institute of Medico-Social Problems of Disability

    Dnipro, 49027
    Ukraine

    Site Not Available

  • Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1

    Kremenchuk, 39623
    Ukraine

    Active - Recruiting

  • 1 Private Clinic Medical Center

    Kyiv,
    Ukraine

    Active - Recruiting

  • Dopomoga Plus medical center

    Kyiv,
    Ukraine

    Site Not Available

  • State Institution "National Research Center for Radiation Medicine of the National Academy of Medical Sciences of Ukraine

    Kyiv, 03115
    Ukraine

    Active - Recruiting

  • Volyn Reg Clin Hospital

    Luts'k, 43005
    Ukraine

    Site Not Available

  • 5 City Clin Hospital

    Lviv, 79013
    Ukraine

    Site Not Available

  • Lviv Regional Central Hospital

    Lviv, 79010
    Ukraine

    Site Not Available

  • Communal institution "City Clinical Hospital №3" of Poltava City Council

    Poltava, 36000
    Ukraine

    Active - Recruiting

  • City Clinical Hospital 2

    Rivne,
    Ukraine

    Site Not Available

  • Sumy Reg Clinical Hospital

    Sumy,
    Ukraine

    Active - Recruiting

  • Salutem

    Vinnytsia, 21018
    Ukraine

    Active - Recruiting

  • LCC Medical center INET-09

    Zaporizhzhya, 69001
    Ukraine

    Site Not Available

  • Zaporizhia Med

    Zaporizhzhya,
    Ukraine

    Site Not Available

  • Zaporizhia Regional Clinic Hospital

    Zaporizhzhya,
    Ukraine

    Site Not Available

  • Zaporizhzhya City Hospital 6

    Zaporizhzhya,
    Ukraine

    Site Not Available

  • Zaporizhzhya Hospital 9

    Zaporizhzhya,
    Ukraine

    Site Not Available

  • Royal Devon Uni NHS

    Exeter, EX2 5DW
    United Kingdom

    Active - Recruiting

  • Royal Hallamshire Hospital

    Sheffield,
    United Kingdom

    Active - Recruiting

  • HonorHealth Research Institute - Bob Bove Neuroscience Institute

    Scottsdale, Arizona 85251
    United States

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  • Neuro of Central Florida

    Altamonte Springs, Florida 32714
    United States

    Active - Recruiting

  • Healthcare Innovations

    Coral Springs, Florida 33067
    United States

    Active - Recruiting

  • Homestead Associates

    Miami, Florida 33032
    United States

    Active - Recruiting

  • Premier Clinical Research

    Miami, Florida 33122
    United States

    Active - Recruiting

  • Baptist Health Lexington

    Nicholasville, Kentucky 40356
    United States

    Active - Recruiting

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

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