Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
NCT ID: NCT05134441
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1050 participants
INTERVENTIONAL
2021-11-18
2032-09-30
Brief Summary
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Detailed Description
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Screening Period: Approximately 28 days Main Treatment Period: Up to 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
IMU-838 tablets
Patients are randomized to IMU-838 or placebo in ratio 1:1
Placebo
Matching placebo, as described for the test product, identical number of tablets as given for IMU-838.
Placebo matching IMU-838 tablets
Patients are randomized to IMU-838 or placebo in ratio 1:1
Interventions
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IMU-838 tablets
Patients are randomized to IMU-838 or placebo in ratio 1:1
Placebo matching IMU-838 tablets
Patients are randomized to IMU-838 or placebo in ratio 1:1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 ofCOVID-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
18 Years
55 Years
ALL
No
Sponsors
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Immunic AG
INDUSTRY
Responsible Party
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Principal Investigators
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Robert J. Fox, MD
Role: PRINCIPAL_INVESTIGATOR
Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
Locations
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Xenoscience, Inc., 21st Century Neurology
Phoenix, Arizona, United States
Bradenton Research Center
Bradenton, Florida, United States
Reliant Medical Research, LLC
Miami, 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
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 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
Clínica Colsanitas S.A. Sede Clínica Universitaria Colombia
Bogotá, , Colombia
Neurocountry Portoazul S.A.S.
Puerto Colombia, , Colombia
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
Athens Medical Center
Athens, , Greece
Thessaloniki Hosptl
Thessaloniki, , Greece
Kanoria Hospital & Research Centre
Gandhinagar, , 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
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
Klaipedos Universitetine Ligonine - Klaipedos Issetines Sklerozes Centra
Klaipėda, , 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
Hospital Universitario La Paz
Madrid, , Spain
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
Countries
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Central Contacts
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Facility Contacts
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Stephen Flitman, Dr.
Role: primary
Eric Martin Folkens, Dr.
Role: primary
Matthew Baker, Dr.
Role: primary
James Scott, Dr.
Role: primary
Daniel Wynn, Dr.
Role: primary
Hajri Gerbi, Dr.
Role: primary
Erion Dushi, Dr.
Role: primary
Sasho Kastrev, Dr.
Role: primary
Ivan Dimitrov, Prof.
Role: primary
Albena Antimova, Dr.
Role: primary
Hristo Lilovski, Dr.
Role: primary
Maya Danovska, Dr.
Role: primary
Plamen Bozhinov, Dr.
Role: primary
Plamen Petkov, Dr.
Role: primary
Georgi Slavov, Prof.
Role: primary
Rositsa Krasteva, Dr.
Role: primary
Kosta Kostov, Dr.
Role: primary
Rosen Ikonomov, Dr.
Role: primary
Penko Shotekov, Prof.
Role: primary
Ivan Milanov, Prof.
Role: primary
Paraskeva Stamenova, Prof.
Role: primary
Ivaylo Tarnev, Prof.
Role: primary
Latchezar Traykov, Prof.
Role: primary
Radostina Dimova, Dr.
Role: primary
Emil Olevski, Dr.
Role: primary
Stratieva Stratina, Dr.
Role: primary
Evgenia Vasileva-Ruscheva, MD
Role: primary
Maria Dimitrova, Dr.
Role: primary
Ara Kaprelyan, MD
Role: primary
Carlos Navas, MD
Role: primary
Laureano Caparroso Diaz, MD
Role: primary
Maia Beridze, Prof.
Role: primary
Natia Zarkua, Dr.
Role: primary
Anna Gauarashvili, Dr.
Role: primary
Darejan Gugutsidze, Dr.
Role: primary
Marina Janelidze, Dr.
Role: primary
Maka Mania, Dr.
Role: primary
Temur Marghania, Dr.
Role: primary
Nana Guldedava, Dr.
Role: primary
Alexander Tsiskaridze, Dr.
Role: primary
Roman Shakarishvili, Dr.
Role: primary
Klimentini Karageorgiou, Prof.
Role: primary
Dimitrios Kazis, Prof.
Role: primary
Devasi Visana, Dr.
Role: primary
Shankara Nellikunja, Dr.
Role: primary
Sanjay Ramteke, Dr.
Role: primary
Laxmikant R. Singh Tomar, Dr.
Role: primary
Santosh Sontakke, Dr.
Role: primary
Sudhir Sharma, Dr.
Role: primary
Abhishek Phatakh, Dr.
Role: primary
Murad Rasheed, Dr.
Role: primary
Eyad Awad, Dr.
Role: primary
Halim Abboud, Dr.
Role: primary
Samia Khoury, Dr.
Role: primary
Renata Balnyte, Dr.
Role: primary
Lina Malciene, Dr.
Role: primary
Elmer G. Lopez Meza, Dr.
Role: primary
Jose L. Ruiz Sandoval, Dr.
Role: primary
Freddy Castro Farfan, Dr.
Role: primary
Minerva Lopez Ruiz
Role: primary
Alma Vigueras, Dr.
Role: primary
Sandra Quiñones Aguilar, Dr.
Role: primary
Guillermo Punzo-Bravo, Dr.
Role: primary
David Reyes Barrios, Dr.
Role: primary
Marco Santos Diaz, Dr.
Role: primary
Stanislav Groppa, Dr.
Role: primary
Olesea Odainic, Dr.
Role: primary
Mihail Gavriliuc, Dr.
Role: primary
Zlatana Perovic, MD
Role: primary
Ljijana Radulovic, MD
Role: primary
Tatjana Stoshevska Deleva, Dr.
Role: primary
Ivan Barbov, Dr.
Role: primary
Antonio Tallon, Dr.
Role: primary
Valeriy Pashkovskyy, MD
Role: primary
Galyna Chmyr, Dr.
Role: primary
Inna Kovalchuk, MD
Role: primary
Olga Kovalenko, MD
Role: primary
Tetiana Kobys, MD
Role: primary
Alla Goloborodko, MD
Role: primary
Nataliya Lytvynenko, MD
Role: primary
Svitlana Skhrobot, Dr.
Role: primary
Volodymyr Smolanka, MD
Role: primary
Other Identifiers
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P3-IMU-838-RMS-01
Identifier Type: -
Identifier Source: org_study_id
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