Multiple Sclerosis Clinical Trial

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

Summary

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER

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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 IMU838 in adult patients with PMS. The study will consist of the following periods:

Screening Period: Approximately 28 days Main Treatment Period: Up to 120 weeks (approximately 2 years) Open Label Extension Period: Up to approximately 8 years

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult patients, age 18 to 65 years (inclusive).
EDSS score at screening between 3.0 to 6.5 (both inclusive)

No evidence of relapse in the last 24 months before randomization, AND Patients diagnosed according to 2017 revised McDonald Criteria 1 and the 2013 revised classification of disease courses 2 as either

SPMS inpatients showing evidence of Gd+MRI lesions (active SPMS) or without Gd+MRI lesions (non-active SPMS) in the last 12 months, OR
PPMS
Willingness and ability to comply with the protocol.
Written informed consent given by the patient before the beginning of any study-related procedure.
Documented evidence of disability progression not temporarily related to a relapse in the last 24 months before randomization, adjudicated by a central independent reviewer

Exclusion Criteria:

Any disease other than MS that may better explain the signs and symptoms, including a history of complete transverse myelitis.
Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e.,presence of anti-NMO [aquaporin-4] antibodies or anti-MOG antibodies).
Previous or current use of MS treatments lifelong, or within a pre-specified time period.
Use of any investigational product within 8 weeks or 5 the respective PK half- life before the date of informed consent, whichever is longer, and throughout the study.For some investigational products, prolonged biological effects beyond 8 weeks should be considered.
Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) within14 days before randomization. In case of known SARS-CoV-2 infection, patients should be randomized no earlier than 14 days after 2 consecutive negative tests confirming virus negative status.The screening period can be extended for these patients to accommodate the required virus negativity.
Positive IFN-gamma release assay (IGRA) for Mycobacterium tuberculosis at SV1.
Positive hepatitis B virus (HBV) surface antigen, hepatitis B core antibody, positive hepatitis C virus (HCV) antibody, and/or HIV-antigen-antibody test at SV1.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

450

Study ID:

NCT05054140

Recruitment Status:

Active, not recruiting

Sponsor:

Immunic AG

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There are 50 Locations for this study

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Dr. Sonia Kalirao
Coral Springs Florida, 33067, United States
Collier Neurologic Specialists
Naples Florida, 34105, United States
Prof. James Scott
Ormond Beach Florida, 32174, United States
Shepherd Center
Atlanta Georgia, 30309, United States
Consultants in Neurology, Ltd.
Northbrook Illinois, 60062, United States
Dr. Daniel Becker
Lutherville Maryland, 21093, United States
Dr. Mirela Cerghet
Detroit Michigan, 48202, United States
University of New Mexico (UNM), MS Specialty Clinic
Albuquerque New Mexico, 87106, United States
MHAT Pulse
Blagoevgrad , 2700, Bulgaria
MHAT"Heart and Brain" EAD
Burgas , , Bulgaria
Dr. Maya Danovska
Pleven , 5800, Bulgaria
Dr. Plamen Bozhinov
Pleven , 5804, Bulgaria
UMHAT Pulmed
Plovdiv , , Bulgaria
Dr. Rositsa Krasteva
Ruse , 7003, Bulgaria
Dr. Nikolay Georgiev
Shumen , 9700, Bulgaria
MHAT Shumen
Shumen , 9705, Bulgaria
Dr. Ivan Milanov
Sofia , 1113, Bulgaria
MHAT Lyulin
Sofia , 1336, Bulgaria
Dr. Rosen Ikonomov
Sofia , 1408, Bulgaria
Dr. Penko Shotekov
Sofia , 1431, Bulgaria
UMHAT Alexandrovska
Sofia , 1431, Bulgaria
Dr. Kana Prinova
Sofia , 1606, Bulgaria
Dr. Kosta Kostov
Sofia , 1606, Bulgaria
MHAT Sveta Sofia
Sofia , , Bulgaria
UMHATSM N.I.Pirogov
Sofia , , Bulgaria
UMHAT Prof. Stoyan Kirkovich
Stara Zagora , , Bulgaria
Dr. Ara Kaprelyan
Varna , 9010, Bulgaria
Montreal Neurological Inst.
Montréal , H3A 2, Canada
The Ottawa Hospital Research Institute
Ottawa , K1H 8, Canada
Fakultni nemocnice
Hradec Králové , , Czechia
Klinik und Poliklinik für Neurologie, Universitätsklinikum Dresden
Dresden , 01307, Germany
Neuro Centrum Science GmbH
Erbach , , Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg , 20251, Germany
Datamed GmbH
Köln , 50935, Germany
Dr. Stanislav Groppa
Chisinau , 2004, Moldova, Republic of
Dr. Mihail Gavriliuc
Chisinau , 2028, Moldova, Republic of
Dr. Olesea Odainic
Chisinau , 2028, Moldova, Republic of
Dr. Eva Strijibis
Amsterdam , 1081B, Netherlands
Alrijne ziekenhuis
Leiderdorp , , Netherlands
Dr. Ana Doneva Skopje 1000
Skopje , 1000, North Macedonia
Dr. Milcho Demerdziev
Skopje , 1000, North Macedonia
Dr. Tatjana Boshkova
Skopje , 1000, North Macedonia
Dr. Robert Bonek
Bydgoszcz , 85-79, Poland
Dr. Maciej Maciejowski
Katowice , 40-57, Poland
Dr. Janusz Zbrojkiewicz
Katowice , 40-68, Poland
Dr. Elzbieta Jasinska
Kielce , 25-72, Poland
Indywidualna Praktyka Lekarska Prof. Rejdak
Lublin , 20-01, Poland
Dr. Marcin Nastaj
Lublin , 20-64, Poland
Instytut Zdrowia
Oświęcim , , Poland
Dr. Justyna Hryniewicz
Plewiska , 62-06, Poland
Clinical Research Center
Poznań , , Poland
EMC PL Certus
Poznań , , Poland
NZOZ "Neuro-kard"
Poznań , , Poland
Dr. Marcin Ratajczak
Szczecin , 70-11, Poland
Warszawska Klinika
Warsaw , , Poland
EMC Instytut Medyczny
Wrocław , , Poland
Dr. Adriana Dulamea
Bucharest , 22328, Romania
Dr. Lacramioara Perju-Dumbrava
Cluj-Napoca , 40001, Romania
Clinical Hospital Center Zemun
Belgrade , , Serbia
Military Medical Academy
Belgrade , , Serbia
Klinicki Centar Kragujevac
Kragujevac , 34000, Serbia
Clinical center of Vojvodina
Novi Sad , , Serbia
Chernivtsi Medical Hospital
Chernivtsi , , Ukraine
Dr. Olena Moroz
Dnipro , 49000, Ukraine
Dr. Pavlo Khaitov
Dnipro , 49128, Ukraine
Dr. Tamara Mishchenko
Kharkiv , 61068, Ukraine
Dr. Oleksandr Doroschenko
Krykhivtsi , 76493, Ukraine
Dr. Larysa Sokolova
Kyiv , 03037, Ukraine
Dr. Galusha
Kyiv , 04106, Ukraine
Dr. Olga Shulga
Lutsk , 43005, Ukraine
Dr.Tetyana Nehrych
Lviv , 79010, Ukraine
Dr. Svitlana Skhrobot
Ternopil , 46024, Ukraine
Dr. Sergii Moskovko
Vinnytsya , 21050, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

450

Study ID:

NCT05054140

Recruitment Status:

Active, not recruiting

Sponsor:


Immunic AG

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