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)

Who is this study for? Adults with relapsing multiple sclerosis
What treatments are being studied? IMU-838
Status: Recruiting
Location: See all (84) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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:

‣ At least 2 relapses in the last 24 months before randomization, or

⁃ At least 1 relapse in the last 12 months before randomization, or

⁃ 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.

Locations
United States
Arizona
Xenoscience, Inc., 21st Century Neurology
RECRUITING
Phoenix
Florida
Bradenton Research Center
RECRUITING
Bradenton
Reliant Medical Research, LLC
WITHDRAWN
Miami
Collier Neurologic Specialists
RECRUITING
Naples
Neurology Associates of Ormond Beach
RECRUITING
Ormond Beach
Illinois
Consultants in Neurology, Ltd
RECRUITING
Northbrook
Other Locations
Albania
Hygeia Hospital Tirana
RECRUITING
Tirana
Klinika Mjekesore Nuova, Neurology Clinic
RECRUITING
Tirana
Bulgaria
MHAT Puls AD
RECRUITING
Blagoevgrad
MHAT Heart and Brain, EAD
RECRUITING
Burgas
Heart and Brain University Hospital
RECRUITING
Pleven
MC Exacta Medica OOD
RECRUITING
Pleven
MC Vita 1
RECRUITING
Pleven
MHAT Avis Medica
RECRUITING
Pleven
UMHAT Dr.Georgi Stranski EAD
RECRUITING
Pleven
UMHAT Sveti Georgi
RECRUITING
Plovdiv
UMHAT Medica Ruse
RECRUITING
Rousse
CCB Medical Institute Ministry of Interior
RECRUITING
Sofia
Diagnostic and Consultative Center Neoclinic
RECRUITING
Sofia
MHAT Sveta Sofia EOOD
RECRUITING
Sofia
MHATNP Sveti Naum, EAD
RECRUITING
Sofia
MHATNPsy Sveti Naum EAD
RECRUITING
Sofia
Military Medical Academy
RECRUITING
Sofia
Military Medical Academy MHAT
RECRUITING
Sofia
UMHAT Alexandrovska
RECRUITING
Sofia
UMHAT Alexandrovska EAD
RECRUITING
Sofia
UMHAT Sveti Ivan Rilski EAD
RECRUITING
Sofia
UMHATEM N.Pirogov
RECRUITING
Sofia
UMHATTsaritsa Yoanna -ISUL
RECRUITING
Sofia
UMHAT Sveta Marina EAD, First Clinic of Neurological Diseases
RECRUITING
Varna
Colombia
Clínica Colsanitas S.A. Sede Clínica Universitaria Colombia
RECRUITING
Bogotá
Neurocountry Portoazul S.A.S.
RECRUITING
Puerto Colombia
Georgia
1st Uni Clinic of Tbilisi LEPL
RECRUITING
Tbilisi
Eristavi Experimental Center
RECRUITING
Tbilisi
J.S.C. Curatio Clinic
RECRUITING
Tbilisi
Katsiashvili Emergency Center
RECRUITING
Tbilisi
Khechinashvili University Hospital
RECRUITING
Tbilisi
LTD Aversi Clinic
RECRUITING
Tbilisi
LTD New Hospitals
RECRUITING
Tbilisi
MediClub Georgia LLC
RECRUITING
Tbilisi
Pineo Medical Ecosystem LTD
RECRUITING
Tbilisi
Sarajishvili Neurology Institute
RECRUITING
Tbilisi
Greece
Athens Medical Center
RECRUITING
Athens
Thessaloniki Hosptl
RECRUITING
Thessaloniki
India
Kanoria Hospital & Research Centre
RECRUITING
Gandhinagar
Mallikatte, Kadri
RECRUITING
Mangalore
Jasleen Hospital
RECRUITING
Nagpur
Sir Ganga Ram Hospital
RECRUITING
New Delhi
Ruby Hospital
RECRUITING
Pune
Indira Gandhi Medical College & Hospital
RECRUITING
Shimla
Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi
RECRUITING
Varanasi
Jordan
TSH Advanced Clinical Center
RECRUITING
Amman
Irbid Speciality Hospital
RECRUITING
Irbid
Lebanon
Hotel Dieu de France Hospital
RECRUITING
Beirut
AUB Medical Center
RECRUITING
Hamra
Lithuania
Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos
RECRUITING
Kaunas
Klaipedos Universitetine Ligonine - Klaipedos Issetines Sklerozes Centra
RECRUITING
Klaipėda
Mexico
Neurociencias Estudios Clínicos S.C
RECRUITING
Culiacán
Instituto Jalisciense de Metabolismo, SC
RECRUITING
Guadalajara
Cliditer S.A de C.V
RECRUITING
Mexico City
Clinstile SA de CV
RECRUITING
Mexico City
Grupo medico camino SC
RECRUITING
Mexico City
Unidad de Investigación en Salud de Chihuahua S.C.
RECRUITING
Mexico City
Centro de Morelia
RECRUITING
Morelia
Faicic de RL de CV
RECRUITING
Veracruz
Sociedad de Metabolismo y Corazon, S.C.
RECRUITING
Veracruz
Montenegro
General Hospital Niksic
RECRUITING
Nikšić
Clinical Center of Montenegro
RECRUITING
Podgorica
Republic of Moldova
Instititute of Emergency Medicine
RECRUITING
Chisinau
Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery Diomid Gherman
RECRUITING
Chisinau
The Diomid Gherman Institute of Neurology and Neurosurgery
RECRUITING
Chisinau
Spain
Hospital Universitario La Paz
RECRUITING
Madrid
Ukraine
Chernihiv Regional Hospital
RECRUITING
Chernivtsi
Neuro Global, LLC
ACTIVE_NOT_RECRUITING
Ivano-frankivsk
Regional Clinical Hospital
RECRUITING
Ivano-frankivsk
Khmelnytsky regional hospital of war veterans
RECRUITING
Khmelnytskyi
Clinical Hospital #15 of the Podilskyi District of the Kyiv City
RECRUITING
Kiev
Kyiv City Hospital 4
RECRUITING
Kyiv
Medbud
ACTIVE_NOT_RECRUITING
Kyiv
SMART medical center
ACTIVE_NOT_RECRUITING
Kyiv
Odesa Regional Clinical Hospital, Department of Neurosurgery
RECRUITING
Odesa
Medical and diagnostic center of a LLC Medcontinent, neurology and rehabilitation center
RECRUITING
Poltava
Ternopil Psycho-Neuro Hospital
RECRUITING
Ternopil
Regional Clinical Center for Neurosurgery and Neurology
RECRUITING
Uzhhorod
Contact Information
Primary
Andreas Muehler, MD
info@imux.com
+49 89 2080 477 00
Time Frame
Start Date: 2021-11-18
Estimated Completion Date: 2032-09
Participants
Target number of participants: 1050
Treatments
Experimental: IMU-838
IMU-838 (vidofludimus calcium), a small molecule inhibitor of DHODH.~Formulation:~Tablets with 15 or 30 mg IMU-838 for once daily oral intake in the morning.
Placebo_comparator: Placebo
Matching placebo, as described for the test product, identical number of tablets as given for IMU-838.
Authors
R. F.
Sponsors
Leads: Immunic AG

This content was sourced from clinicaltrials.gov

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