Clinical trial NCT05054140: Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Progressive Multiple Sclerosis
Lead sponsor: Immunic AG
Sponsor class: INDUSTRY
First posted: 2021-09-23
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

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

  1. SPMS inpatients showing evidence of Gd+MRI lesions (active SPMS) or without Gd+MRI lesions (non-active SPMS) in the last 12 months, OR
  2. 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.

Primary outcomes:
measure: Efficacy of IMU-838 versus placebo
timeFrame: 120 weeks
Secondary outcomes:
measure: Efficacy of IMU-838 versus placebo
timeFrame: 120 weeks
measure: Efficacy of IMU-838 versus placebo in terms of disability worsening
timeFrame: 120 weeks
Other outcomes:
measure: Safety IMU-838 versus placebo
timeFrame: 120 weeks
Locations:
city: Coral Springs
country: United States
facility: Dr. Sonia Kalirao
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists
state: Florida
city: Ormond Beach
country: United States
facility: Prof. James Scott
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Northbrook
country: United States
facility: Consultants in Neurology, Ltd.
state: Illinois
city: Lutherville
country: United States
facility: Dr. Daniel Becker
state: Maryland
city: Detroit
country: United States
facility: Dr. Mirela Cerghet
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico (UNM), MS Specialty Clinic
state: New Mexico
city: Blagoevgrad
country: Bulgaria
facility: MHAT Pulse
city: Burgas
country: Bulgaria
facility: MHAT"Heart and Brain" EAD
city: Pleven
country: Bulgaria
facility: Dr. Maya Danovska
city: Pleven
country: Bulgaria
facility: Dr. Plamen Bozhinov
city: Plovdiv
country: Bulgaria
facility: UMHAT Pulmed
city: Ruse
country: Bulgaria
facility: Dr. Rositsa Krasteva
city: Shumen
country: Bulgaria
facility: Dr. Nikolay Georgiev
city: Shumen
country: Bulgaria
facility: MHAT Shumen
city: Sofia
country: Bulgaria
facility: Dr. Ivan Milanov
city: Sofia
country: Bulgaria
facility: MHAT Lyulin
city: Sofia
country: Bulgaria
facility: Dr. Rosen Ikonomov
city: Sofia
country: Bulgaria
facility: Dr. Penko Shotekov
city: Sofia
country: Bulgaria
facility: UMHAT Alexandrovska
city: Sofia
country: Bulgaria
facility: Dr. Kana Prinova
city: Sofia
country: Bulgaria
facility: Dr. Kosta Kostov
city: Sofia
country: Bulgaria
facility: MHAT Sveta Sofia
city: Sofia
country: Bulgaria
facility: UMHATSM N.I.Pirogov
city: Stara Zagora
country: Bulgaria
facility: UMHAT Prof. Stoyan Kirkovich
city: Varna
country: Bulgaria
facility: Dr. Ara Kaprelyan
city: Montréal
country: Canada
facility: Montreal Neurological Inst.
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research Institute
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice
city: Dresden
country: Germany
facility: Klinik und Poliklinik für Neurologie, Universitätsklinikum Dresden
city: Erbach
country: Germany
facility: Neuro Centrum Science GmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Köln
country: Germany
facility: Datamed GmbH
city: Chisinau
country: Moldova, Republic of
facility: Dr. Stanislav Groppa
city: Chisinau
country: Moldova, Republic of
facility: Dr. Mihail Gavriliuc
city: Chisinau
country: Moldova, Republic of
facility: Dr. Olesea Odainic
city: Amsterdam
country: Netherlands
facility: Dr. Eva Strijibis
city: Leiderdorp
country: Netherlands
facility: Alrijne ziekenhuis
city: Skopje
country: North Macedonia
facility: Dr. Ana Doneva Skopje 1000
city: Skopje
country: North Macedonia
facility: Dr. Milcho Demerdziev
city: Skopje
country: North Macedonia
facility: Dr. Tatjana Boshkova
city: Bydgoszcz
country: Poland
facility: Dr. Robert Bonek
city: Katowice
country: Poland
facility: Dr. Maciej Maciejowski
city: Katowice
country: Poland
facility: Dr. Janusz Zbrojkiewicz
city: Kielce
country: Poland
facility: Dr. Elzbieta Jasinska
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska Prof. Rejdak
city: Lublin
country: Poland
facility: Dr. Marcin Nastaj
city: Oświęcim
country: Poland
facility: Instytut Zdrowia
city: Plewiska
country: Poland
facility: Dr. Justyna Hryniewicz
city: Poznań
country: Poland
facility: Clinical Research Center
city: Poznań
country: Poland
facility: EMC PL Certus
city: Poznań
country: Poland
facility: NZOZ "Neuro-kard"
city: Szczecin
country: Poland
facility: Dr. Marcin Ratajczak
city: Warsaw
country: Poland
facility: Warszawska Klinika
city: Wrocław
country: Poland
facility: EMC Instytut Medyczny
city: Bucharest
country: Romania
facility: Dr. Adriana Dulamea
city: Cluj-Napoca
country: Romania
facility: Dr. Lacramioara Perju-Dumbrava
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zemun
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Kragujevac
country: Serbia
facility: Klinicki Centar Kragujevac
city: Novi Sad
country: Serbia
facility: Clinical center of Vojvodina
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Medical Hospital
city: Dnipro
country: Ukraine
facility: Dr. Olena Moroz
city: Dnipro
country: Ukraine
facility: Dr. Pavlo Khaitov
city: Kharkiv
country: Ukraine
facility: Dr. Tamara Mishchenko
city: Krykhivtsi
country: Ukraine
facility: Dr. Oleksandr Doroschenko
city: Kyiv
country: Ukraine
facility: Dr. Larysa Sokolova
city: Kyiv
country: Ukraine
facility: Dr. Galusha
city: Lutsk
country: Ukraine
facility: Dr. Olga Shulga
city: Lviv
country: Ukraine
facility: Dr.Tetyana Nehrych
city: Ternopil
country: Ukraine
facility: Dr. Svitlana Skhrobot
city: Vinnytsya
country: Ukraine
facility: Dr. Sergii Moskovko
Study officials:
affiliation: Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
name: Robert J. Fox, MD
role: PRINCIPAL_INVESTIGATOR
References: