Multiple Sclerosis Clinical Trial

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

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)

View Full Description

Full 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: Up to 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years

View Eligibility Criteria

Eligibility Criteria

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:

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.

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 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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1050

Study ID:

NCT05134441

Recruitment Status:

Recruiting

Sponsor:

Immunic AG

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There are 38 Locations for this study

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Xenoscience, Inc., 21st Century Neurology
Phoenix Arizona, 85004, United States More Info
Stephen Flitman, Dr.
Contact
Bradenton Research Center
Bradenton Florida, 34205, United States More Info
Eric Martin Folkens, Dr.
Contact
Reliant Medical Research, LLC
Miami Florida, 33165, United States
Collier Neurologic Specialists
Naples Florida, 34105, United States More Info
Matthew Baker, Dr.
Contact
Neurology Associates of Ormond Beach
Ormond Beach Florida, 32174, United States More Info
James Scott, Dr.
Contact
Consultants in Neurology, Ltd
Northbrook Illinois, 60062, United States More Info
Daniel Wynn, Dr.
Contact
Klinika Mjekesore Nuova, Neurology Clinic
Tirana , 1005, Albania More Info
Hajri Gerbi, Dr.
Contact
Hygeia Hospital Tirana
Tirana , , Albania More Info
Erion Dushi, Dr.
Contact
MHAT Puls AD
Blagoevgrad , 2700, Bulgaria More Info
Sasho Kastrev, Dr.
Contact
MHAT "Heart and Brain", EAD
Burgas , 8000, Bulgaria More Info
Ivan Dimitrov, Prof.
Contact
MC Exacta Medica OOD
Pleven , 5800, Bulgaria More Info
Albena Antimova, Dr.
Contact
MHAT Avis Medica
Pleven , 5800, Bulgaria More Info
Hristo Lilovski, Dr.
Contact
UMHAT Dr.Georgi Stranski EAD
Pleven , 5800, Bulgaria More Info
Maya Danovska, Dr.
Contact
Heart and Brain University Hospital
Pleven , , Bulgaria More Info
Plamen Bozhinov, Dr.
Contact
MC Vita 1
Pleven , , Bulgaria More Info
Plamen Petkov, Dr.
Contact
UMHAT Sveti Georgi
Plovdiv , 4002, Bulgaria More Info
Georgi Slavov, Prof.
Contact
UMHAT "Medica Ruse"
Ruse , , Bulgaria More Info
Rositsa Krasteva, Dr.
Contact
CCB Medical Institute Ministry of Interior
Sofia , 1000, Bulgaria More Info
Kosta Kostov, Dr.
Contact
Diagnostic and Consultative Center Neoclinic
Sofia , 1000, Bulgaria More Info
Rosen Ikonomov, Dr.
Contact
UMHAT "Sveti Ivan Rilski" EAD
Sofia , 1000, Bulgaria More Info
Penko Shotekov, Prof.
Contact
MHATNP "Sveti Naum", EAD
Sofia , 1113, Bulgaria More Info
Ivan Milanov, Prof.
Contact
MHATNPsy Sveti Naum EAD
Sofia , 1113, Bulgaria More Info
Paraskeva Stamenova, Prof.
Contact
UMHAT "Alexandrovska" EAD
Sofia , 1431, Bulgaria More Info
Ivaylo Tarnev, Prof.
Contact
UMHAT "Alexandrovska"
Sofia , 1431, Bulgaria More Info
Latchezar Traykov, Prof.
Contact
Military Medical Academy MHAT
Sofia , 1606, Bulgaria More Info
Radostina Dimova, Dr.
Contact
MHAT "Sveta Sofia" EOOD
Sofia , 1618, Bulgaria More Info
Emil Olevski, Dr.
Contact
Military Medical Academy
Sofia , , Bulgaria More Info
Stratieva Stratina, Dr.
Contact
UMHAT"Tsaritsa Yoanna -ISUL
Sofia , , Bulgaria More Info
Evgenia Vasileva-Ruscheva, MD
Contact
UMHATEM N.Pirogov
Sofia , , Bulgaria More Info
Maria Dimitrova, Dr.
Contact
UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases
Varna , , Bulgaria More Info
Ara Kaprelyan, MD
Contact
Clínica Colsanitas S.A. Sede Clínica Universitaria Colombia
Bogotá , , Colombia More Info
Carlos Navas, MD
Contact
Neurocountry Portoazul S.A.S.
Puerto Colombia , , Colombia More Info
Laureano Caparroso Diaz, MD
Contact
1st Uni Clinic of Tbilisi LEPL
Tbilisi , 0141, Georgia More Info
Maia Beridze, Prof.
Contact
Eristavi Experimental Center
Tbilisi , , Georgia More Info
Natia Zarkua, Dr.
Contact
J.S.C. Curatio Clinic
Tbilisi , , Georgia More Info
Anna Gauarashvili, Dr.
Contact
Katsiashvili Emergency Center
Tbilisi , , Georgia More Info
Darejan Gugutsidze, Dr.
Contact
Khechinashvili University Hospital
Tbilisi , , Georgia More Info
Marina Janelidze, Dr.
Contact
LTD Aversi Clinic
Tbilisi , , Georgia More Info
Maka Mania, Dr.
Contact
LTD New Hospitals
Tbilisi , , Georgia More Info
Temur Marghania, Dr.
Contact
MediClub Georgia LLC
Tbilisi , , Georgia More Info
Nana Guldedava, Dr.
Contact
Pineo Medical Ecosystem LTD
Tbilisi , , Georgia More Info
Alexander Tsiskaridze, Dr.
Contact
Sarajishvili Neurology Institute
Tbilisi , , Georgia More Info
Roman Shakarishvili, Dr.
Contact
Athens Medical Center
Athens , , Greece More Info
Klimentini Karageorgiou, Prof.
Contact
Thessaloniki Hosptl
Thessaloníki , , Greece More Info
Dimitrios Kazis, Prof.
Contact
Kanoria Hospital & Research Centre
Gandhinagar , 38242, India More Info
Devasi Visana, Dr.
Contact
Mallikatte, Kadri
Mangalore , 57500, India More Info
Shankara Nellikunja, Dr.
Contact
Jasleen Hospital
Nagpur , , India More Info
Sanjay Ramteke, Dr.
Contact
Sir Ganga Ram Hospital
New Delhi , 11006, India More Info
Laxmikant R. Singh Tomar, Dr.
Contact
Ruby Hospital
Pune , 41100, India More Info
Santosh Sontakke, Dr.
Contact
Indira Gandhi Medical College & Hospital
Shimla , 17100, India More Info
Sudhir Sharma, Dr.
Contact
Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi
Varanasi , 22100, India More Info
Abhishek Phatakh, Dr.
Contact
TSH Advanced Clinical Center
Amman , , Jordan More Info
Murad Rasheed, Dr.
Contact
Irbid Speciality Hospital
Irbid , , Jordan More Info
Eyad Awad, Dr.
Contact
Hotel Dieu de France Hospital
Beirut , , Lebanon More Info
Halim Abboud, Dr.
Contact
AUB Medical Center
Hamra , 1107-, Lebanon More Info
Samia Khoury, Dr.
Contact
Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos
Kaunas , 50161, Lithuania More Info
Renata Balnyte, Dr.
Contact
Klaipedos Universitetine Ligonine - Klaipedos Issetines Sklerozes Centra
Klaipėda , 92288, Lithuania More Info
Lina Malciene, Dr.
Contact
Neurociencias Estudios Clínicos S.C
Culiacán , 80020, Mexico More Info
Elmer G. Lopez Meza, Dr.
Contact
Instituto Jalisciense de Metabolismo, SC
Guadalajara , 44670, Mexico More Info
Jose L. Ruiz Sandoval, Dr.
Contact
Grupo medico camino SC
Mexico City , 03310, Mexico More Info
Freddy Castro Farfan, Dr.
Contact
Cliditer S.A de C.V
Mexico City , 06700, Mexico More Info
Minerva Lopez Ruiz
Contact
Unidad de Investigación en Salud de Chihuahua S.C.
Mexico City , 14050, Mexico More Info
Alma Vigueras, Dr.
Contact
Clinstile SA de CV
Mexico City , , Mexico More Info
Sandra Quiñones Aguilar, Dr.
Contact
Centro de Morelia
Morelia , 58000, Mexico More Info
Guillermo Punzo-Bravo, Dr.
Contact
Faicic de RL de CV
Veracruz , 91900, Mexico More Info
David Reyes Barrios, Dr.
Contact
Sociedad de Metabolismo y Corazon, S.C.
Veracruz , 91900, Mexico More Info
Marco Santos Diaz, Dr.
Contact
Instititute of Emergency Medicine
Chisinau , , Moldova, Republic of More Info
Stanislav Groppa, Dr.
Contact
Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery "Diomid Gherman"
Chisinau , , Moldova, Republic of More Info
Olesea Odainic, Dr.
Contact
The Diomid Gherman Institute of Neurology and Neurosurgery
Chisinau , , Moldova, Republic of More Info
Mihail Gavriliuc, Dr.
Contact
General Hospital Niksic
Nikšić , , Montenegro More Info
Zlatana Perovic, MD
Contact
Clinical Center of Montenegro
Podgorica , , Montenegro More Info
Ljijana Radulovic, MD
Contact
Hospital "8 mi Septemvri"
Skopje , , North Macedonia More Info
Tatjana Stoshevska Deleva, Dr.
Contact
University Clinic of Neurology
Skopje , , North Macedonia More Info
Ivan Barbov, Dr.
Contact
Hospital Universitario La Paz
Madrid , , Spain More Info
Antonio Tallon, Dr.
Contact
Chernihiv Regional Hospital
Chernivtsi , , Ukraine More Info
Valeriy Pashkovskyy, MD
Contact
Regional Clinical Hospital
Ivano-Frankivs'k , 76008, Ukraine More Info
Galyna Chmyr, Dr.
Contact
Neuro Global, LLC
Ivano-Frankivs'k , 76493, Ukraine
Khmelnytsky regional hospital of war veterans
Khmelnytskyi , , Ukraine More Info
Inna Kovalchuk, MD
Contact
Clinical Hospital #15 of the Podilskyi District of the Kyiv City
Kiev , , Ukraine More Info
Olga Kovalenko, MD
Contact
Kyiv City Hospital 4
Kiew , , Ukraine More Info
Tetiana Kobys, MD
Contact
"Medbud"
Kyiv , 3037, Ukraine
SMART medical center
Kyiv , 4212, Ukraine
Odesa Regional Clinical Hospital, Department of Neurosurgery
Odesa , , Ukraine More Info
Alla Goloborodko, MD
Contact
Medical and diagnostic center of a LLC "Medcontinent", neurology and rehabilitation center
Poltava , , Ukraine More Info
Nataliya Lytvynenko, MD
Contact
Ternopil Psycho-Neuro Hospital
Ternopil' , 46027, Ukraine More Info
Svitlana Skhrobot, Dr.
Contact
Regional Clinical Center for Neurosurgery and Neurology
Uzhhorod , , Ukraine More Info
Volodymyr Smolanka, MD
Contact

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1050

Study ID:

NCT05134441

Recruitment Status:

Recruiting

Sponsor:


Immunic AG

How clear is this clinincal trial information?

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