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

Multiple Sclerosis Clinical Trial

— CALLIPER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05054140
• Other study ID #: P2-IMU-838-PMS
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 30, 2021
• Est. completion date: January 7, 2025

Study information

• Verified date: April 2024
• Source: Immunic AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: January 7, 2025
• Est. primary completion date: January 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis

Intervention

Drug:
• IMU-838
IMU-838 tablets
• Placebo matching IMU-838
Placebo matching IMU-838 tablets

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Immunic AG

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Germany,  Moldova, Republic of,  Netherlands,  North Macedonia,  Poland,  Romania,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety IMU-838 versus placebo	Adverse events (AEs) and serious AEs (SAEs) during MT Period	120 weeks
Primary	Efficacy of IMU-838 versus placebo	Annualized rate of percent brain volume change (PBVC) during MT period	120 weeks
Secondary	Efficacy of IMU-838 versus placebo	Annualized rate of change in brain parenchymal fraction (BPF) during MT Period	120 weeks
Secondary	Efficacy of IMU-838 versus placebo in terms of disability worsening	Time to 24-week confirmed disability worsening based on expanded disability status scale (EDSS) during MT Period	120 weeks