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ACTIVE NOT RECRUITING
NCT05134441
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-1)

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-1)

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

1121

Start Date

2021-11-18

Completion Date

2033-09

Last Updated

2026-02-23

Healthy Volunteers

No

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

Locations (91)

Xenoscience, Inc., 21st Century Neurology

Phoenix, Arizona, United States

Regina Berkovich MD, PhD Inc. MS Neurology

West Hollywood, California, United States

Bradenton Research Center

Bradenton, Florida, United States

Collier Neurologic Specialists

Naples, Florida, United States

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States

Consultants in Neurology, Ltd

Northbrook, Illinois, United States

Klinika Mjekesore Nuova, Neurology Clinic

Tirana, Albania

Hygeia Hospital Tirana

Tirana, Albania

University Hospital Center Mustapha Pacha, Algiers

Algiers, Algeria

University Hospital Center Ibn Sina, Annaba

Annaba, Algeria

University Hospital Center of Oran

Oran, Algeria

MHAT Puls AD

Blagoevgrad, Bulgaria

MHAT "Heart and Brain", EAD

Burgas, Bulgaria

MC Exacta Medica OOD

Pleven, Bulgaria

MHAT Avis Medica

Pleven, Bulgaria

UMHAT Dr.Georgi Stranski EAD

Pleven, Bulgaria

Heart and Brain University Hospital

Pleven, Bulgaria

MC Vita 1

Pleven, Bulgaria

UMHAT "Kaspela"EOOD

Plovdiv, Bulgaria

UMHAT "Pulmed" Ltd

Plovdiv, Bulgaria

UMHAT Sveti Georgi

Plovdiv, Bulgaria

UMHAT "Medica Ruse"

Rousse, Bulgaria

CCB Medical Institute Ministry of Interior

Sofia, Bulgaria

Diagnostic and Consultative Center Neoclinic

Sofia, Bulgaria

UMHAT "Sveti Ivan Rilski" EAD

Sofia, Bulgaria

MHATNP "Sveti Naum", EAD

Sofia, Bulgaria

MHATNPsy Sveti Naum EAD

Sofia, Bulgaria

UMHAT "Alexandrovska" EAD

Sofia, Bulgaria

UMHAT "Alexandrovska"

Sofia, Bulgaria

Military Medical Academy MHAT

Sofia, Bulgaria

MHAT "Sveta Sofia" EOOD

Sofia, Bulgaria

Military Medical Academy

Sofia, Bulgaria

UMHAT"Tsaritsa Yoanna -ISUL

Sofia, Bulgaria

UMHATEM N.Pirogov

Sofia, Bulgaria

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

Varna, Bulgaria

1st Uni Clinic of Tbilisi LEPL

Tbilisi, Georgia

Eristavi Experimental Center

Tbilisi, Georgia

J.S.C. Curatio Clinic

Tbilisi, Georgia

Katsiashvili Emergency Center

Tbilisi, Georgia

Khechinashvili University Hospital

Tbilisi, Georgia

LTD Aversi Clinic

Tbilisi, Georgia

LTD New Hospitals

Tbilisi, Georgia

MediClub Georgia LLC

Tbilisi, Georgia

Pineo Medical Ecosystem LTD

Tbilisi, Georgia

Sarajishvili Neurology Institute

Tbilisi, Georgia

University Hospital Muenster, Institute Translational Neurology dept. Neurology

Münster, Germany

Medstar Speciality Hospital

Bangalore, India

Mallikatte, Kadri

Mangalore, India

Jasleen Hospital

Nagpur, India

Sir Ganga Ram Hospital

New Delhi, India

Ruby Hospital

Pune, India

Indira Gandhi Medical College & Hospital

Shimla, India

Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi

Varanasi, India

Istiklal Hospital

Amman, Jordan

Jordan University Hospital

Amman, Jordan

TSH Advanced Clinical Center

Amman, Jordan

Irbid Speciality Hospital

Irbid, Jordan

Hotel Dieu de France Hospital

Beirut, Lebanon

AUB Medical Center

Hamra, Lebanon

Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos

Kaunas, Lithuania

Neurociencias Estudios Clínicos S.C

Culiacán, Mexico

Instituto Jalisciense de Metabolismo, SC

Guadalajara, Mexico

Grupo medico camino SC

Mexico City, Mexico

Cliditer S.A de C.V

Mexico City, Mexico

Unidad de Investigación en Salud de Chihuahua S.C.

Mexico City, Mexico

Clinstile SA de CV

Mexico City, Mexico

Centro de Morelia

Morelia, Mexico

Faicic de RL de CV

Veracruz, Mexico

Sociedad de Metabolismo y Corazon, S.C.

Veracruz, Mexico

Instititute of Emergency Medicine

Chisinau, Moldova

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

Chisinau, Moldova

The Diomid Gherman Institute of Neurology and Neurosurgery

Chisinau, Moldova

General Hospital Niksic

Nikšić, Montenegro

Clinical Center of Montenegro

Podgorica, Montenegro

Hospital "8 mi Septemvri"

Skopje, North Macedonia

University Clinic of Neurology

Skopje, North Macedonia

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

Lublin, Poland

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

Chernihiv, Ukraine

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

Chernivtsi, Ukraine

Chernihiv Regional Hospital

Chernivtsi, Ukraine

Regional Clinical Hospital

Ivano-Frankivsk, Ukraine

Neuro Global, LLC

Ivano-Frankivsk, Ukraine

Khmelnytsky regional hospital of war veterans

Khmelnytskyi, Ukraine

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

Kiev, Ukraine

"Medbud"

Kyiv, Ukraine

SMART medical center

Kyiv, Ukraine

Kyiv City Hospital 4

Kyiv, Ukraine

Odesa Regional Clinical Hospital, Department of Neurosurgery

Odesa, Ukraine

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

Poltava, Ukraine

Ternopil Psycho-Neuro Hospital

Ternopil, Ukraine

Regional Clinical Center for Neurosurgery and Neurology

Uzhhorod, Ukraine