Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05201638

PHASE3

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

Sponsor: Immunic AG

View on ClinicalTrials.gov

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)

Official title: A 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)

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

1100

Start Date

2022-01-12

Completion Date

2033-10

Last Updated

2026-02-23

Healthy Volunteers

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

IMU-838 tablets

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

DRUG

Placebo matching IMU-838 tablets

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

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 secondary progressive 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 to randomization. * Willingness and ability to comply with the protocol. * Written informed consent given prior to any study-related procedure. 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, 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 of COVID-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

Locations (76)

Neuro of Central Florida

Altamonte Springs, Florida, United States

Healthcare Innovations

Coral Springs, Florida, United States

Heratsi Hospital Complex 1

Yerevan, Armenia

Saint Gregory the Illuminator Medical Center

Yerevan, Armenia

Erebouni Medical Center

Yerevan, Armenia

UCC of Rep of Srpska

Banja Luka, Bosnia and Herzegovina

Cantonal Hospital Bihac Dr. Irfan Ljubijankic

Bihać, Bosnia and Herzegovina

University Clinical Center of Sarajevo

Sarajevo, Bosnia and Herzegovina

University Clinical Center Sarajevo

Sarajevo, Bosnia and Herzegovina

University Clinical Center Tuzla

Tuzla, Bosnia and Herzegovina

Astra Clinic

Tallinn, Estonia

University Hospital Muenster, Institute Translational Neurology dept. Neurology

Münster, Germany

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

Chandigarh, India

Fortis Memorial Research Institute

Gurugramam, India

Polakulath Narayanan Renai Medicity MSSH

Kochi, India

Dr Ram Manohar Lohia Institute of Medical Sciences

Lucknow, India

All India Institute of Medical Sciences

New Delhi, India

GB Pant Institute of Postgraduate Medical Education and Research

New Delhi, India

SRI Guru Ram Das Institute of Medical Sciences and Research

Punjābi Bāgh, India

DKS PGI

Raipur, India

Hospital Nacional Dos de Mayo

Lima, Peru

NZOZ Novo-Med

Katowice, Poland

NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"

Katowice, Poland

Neuro-Medic Janusz Zbrojkiewicz

Katowice, Poland

NZOZ Neuromed

Lublin, Poland

Indywidualna Praktyka Lekarska prof. Konrad Rejdak

Lublin, Poland

Instytut Zdrowia Boczarska

Oświęcim, Poland

NZOZ Hertmanowskiej

Plewiska, Poland

NZOZ Neuro-Kard

Poznan, Poland

Centrum Medyczne NeuroProtect

Warsaw, Poland

FutureMeds Warszawa Centrum

Warsaw, Poland

Centrum Med. Ibismed

Zabrze, Poland

Clubul Sanatatii SRL

Campulung Muscel, Romania

Spitalul clinic CF Constanta

Constanța, Romania

Aria Clinic SRL

Sibiu, Romania

Klinicko bolnicki centar Dr Dragisa Misovic - Dedinje

Belgrade, Serbia

Klinicko bolnicki centar Zvezdara

Belgrade, Serbia

Vojnomedicinska akademija

Belgrade, Serbia

Univerzitetski Klinicki centar Kragujevac

Kragujevac, Serbia

General Hospital Leskovac

Leskovac, Serbia

Univerzitetski Klinicki centar Nis

Niš, Serbia

Hsptl Sveti Vracevi

Novi Kneževac, Serbia

General Hospital Uzice

Užice, Serbia

Klinicko Bolnicki centar Zemun

Zemun, Serbia

Opsta bolnica Djordje Jovanovic Zrenjanin

Zrenjanin, Serbia

Adana Baskent Hospital

Adana, Turkey (Türkiye)

Uludag University Hospital

Bursa, Turkey (Türkiye)

Bezmialem Vakif University Hospital

Istanbul, Turkey (Türkiye)

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

Istanbul, Turkey (Türkiye)

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

Istanbul, Turkey (Türkiye)

Haydar Pasa Num. EAH

Istanbul, Turkey (Türkiye)

Kocaeli University Research and Application Hospital

Kocaeli, Turkey (Türkiye)

Kutahya Uni Evliya Celebi Hspt

Kütahya, Turkey (Türkiye)

Manisa Celal Bayar University Hafsa Sultan Hospital

Manisa, Turkey (Türkiye)

Sakarya Egitim ve Arastirma Hast

Sakarya, Turkey (Türkiye)

19 Mayis University Medical Faculty Hospital Health Application and Research Center

Samsun, Turkey (Türkiye)

Namik Kemal Uni Hospital

Tekirdağ, Turkey (Türkiye)

Communal noncommercial enterprise "First Cherkasy City Hospital"

Cherkasy, Ukraine

MS Diagnosis Treatment Center

Cherkasy, Ukraine

Chernihiv City Hospital 4

Chernihiv, Ukraine

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

Dnipro, Ukraine

Ukrainian State Research Institute of Medico-Social Problems of Disability

Dnipro, Ukraine

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

Dnipro, Ukraine

Dnipro City Hospital 6

Dnipro, Ukraine

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

Kremenchuk, Ukraine

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

Kyiv, Ukraine

1 Private Clinic Medical Center

Kyiv, Ukraine

Dopomoga Plus medical center

Kyiv, Ukraine

Volyn Reg Clin Hospital

Lutsk, Ukraine

Lviv Regional Central Hospital

Lviv, Ukraine

5 City Clin Hospital

Lviv, Ukraine

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

Poltava, Ukraine

City Clinical Hospital 2

Rivne, Ukraine

Sumy Reg Clinical Hospital

Sumy, Ukraine

Salutem

Vinnytsia, Ukraine

Royal Hallamshire Hospital

Sheffield, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (76)