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

Phase 2

Active, not recruiting

• Conditions: Multiple Sclerosis
• Interventions: Drug: IMU-838; Drug: Placebo matching IMU-838

• Registration Number: NCT05054140
• Lead Sponsor: Immunic AG

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

Study Timeline

• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-23
• Study Start: 2021-09-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Primary Completion: 2025-01-07
• Study Completion: 2025-01-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMU-838	IMU-838	IMU-838 as tablet; Administration: Oral - daily
Placebo	Placebo matching IMU-838	Matching placebo as tablet; Administration: Oral - daily

Primary Outcome Measures

Name	Time	Method
Efficacy of IMU-838 versus placebo	120 weeks	Annualized rate of percent brain volume change (PBVC) during MT period

Secondary Outcome Measures

Name	Time	Method
Efficacy of IMU-838 versus placebo in terms of disability worsening	120 weeks	Time to 24-week confirmed disability worsening based on expanded disability status scale (EDSS) during MT Period
Efficacy of IMU-838 versus placebo	120 weeks	Annualized rate of change in brain parenchymal fraction (BPF) during MT Period

Trial Locations

Locations (73)

Dr. Penko Shotekov; 🇧🇬 Sofia, Bulgaria

UMHAT Alexandrovska; 🇧🇬 Sofia, Bulgaria

Dr. Eva Strijibis; 🇳🇱 Amsterdam, Netherlands

Instytut Zdrowia; 🇵🇱 Oświęcim, Poland

Dr. Olena Moroz; 🇺🇦 Dnipro, Ukraine

Shepherd Center; 🇺🇸 Atlanta, Georgia, United States

MHAT Pulse; 🇧🇬 Blagoevgrad, Bulgaria

Consultants in Neurology, Ltd.; 🇺🇸 Northbrook, Illinois, United States

Datamed GmbH; 🇩🇪 Köln, Germany

University of New Mexico (UNM), MS Specialty Clinic; 🇺🇸 Albuquerque, New Mexico, United States

Dr. Daniel Becker; 🇺🇸 Lutherville, Maryland, United States

Klinik und Poliklinik für Neurologie, Universitätsklinikum Dresden; 🇩🇪 Dresden, Germany

Universitätsklinikum Hamburg Eppendorf; 🇩🇪 Hamburg, Germany

Montreal Neurological Inst.; 🇨🇦 Montréal, Canada

Dr. Ara Kaprelyan; 🇧🇬 Varna, Bulgaria

Dr. Stanislav Groppa; 🇲🇩 Chisinau, Moldova, Republic of

Dr. Mihail Gavriliuc; 🇲🇩 Chisinau, Moldova, Republic of

Alrijne ziekenhuis; 🇳🇱 Leiderdorp, Netherlands

Dr. Maciej Maciejowski; 🇵🇱 Katowice, Poland

Dr. Pavlo Khaitov; 🇺🇦 Dnipro, Ukraine

Dr. Sonia Kalirao; 🇺🇸 Coral Springs, Florida, United States

Collier Neurologic Specialists; 🇺🇸 Naples, Florida, United States

MHAT Sveta Sofia; 🇧🇬 Sofia, Bulgaria

Dr. Kana Prinova; 🇧🇬 Sofia, Bulgaria

UMHAT Prof. Stoyan Kirkovich; 🇧🇬 Stara Zagora, Bulgaria

Fakultni nemocnice; 🇨🇿 Hradec Králové, Czechia

The Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Canada

Neuro Centrum Science GmbH; 🇩🇪 Erbach, Germany

Clinical center of Vojvodina; 🇷🇸 Novi Sad, Serbia

Dr. Mirela Cerghet; 🇺🇸 Detroit, Michigan, United States

Dr. Olesea Odainic; 🇲🇩 Chisinau, Moldova, Republic of

Dr. Robert Bonek; 🇵🇱 Bydgoszcz, Poland

Dr. Janusz Zbrojkiewicz; 🇵🇱 Katowice, Poland

Dr. Marcin Nastaj; 🇵🇱 Lublin, Poland

EMC PL Certus; 🇵🇱 Poznań, Poland

Dr. Lacramioara Perju-Dumbrava; 🇷🇴 Cluj-Napoca, Romania

Dr. Oleksandr Doroschenko; 🇺🇦 Krykhivtsi, Ukraine

Warszawska Klinika; 🇵🇱 Warsaw, Poland

MHAT"Heart and Brain" EAD; 🇧🇬 Burgas, Bulgaria

Dr. Ivan Milanov; 🇧🇬 Sofia, Bulgaria

Dr. Maya Danovska; 🇧🇬 Pleven, Bulgaria

Dr. Rosen Ikonomov; 🇧🇬 Sofia, Bulgaria

Dr. Kosta Kostov; 🇧🇬 Sofia, Bulgaria

Military Medical Academy; 🇷🇸 Belgrade, Serbia

Dr. Sergii Moskovko; 🇺🇦 Vinnytsya, Ukraine

UMHAT Pulmed; 🇧🇬 Plovdiv, Bulgaria

Dr. Nikolay Georgiev; 🇧🇬 Shumen, Bulgaria

Dr. Tatjana Boshkova; 🇲🇰 Skopje, North Macedonia

Indywidualna Praktyka Lekarska Prof. Rejdak; 🇵🇱 Lublin, Poland

Dr. Tamara Mishchenko; 🇺🇦 Kharkiv, Ukraine

Dr. Olga Shulga; 🇺🇦 Lutsk, Ukraine

Dr.Tetyana Nehrych; 🇺🇦 Lviv, Ukraine

Dr. Svitlana Skhrobot; 🇺🇦 Ternopil, Ukraine

Dr. Plamen Bozhinov; 🇧🇬 Pleven, Bulgaria

MHAT Lyulin; 🇧🇬 Sofia, Bulgaria

Dr. Ana Doneva Skopje 1000; 🇲🇰 Skopje, North Macedonia

Dr. Elzbieta Jasinska; 🇵🇱 Kielce, Poland

Clinical Research Center; 🇵🇱 Poznań, Poland

NZOZ "Neuro-kard"; 🇵🇱 Poznań, Poland

EMC Instytut Medyczny; 🇵🇱 Wrocław, Poland

Klinicki Centar Kragujevac; 🇷🇸 Kragujevac, Serbia

Dr. Galusha; 🇺🇦 Kyiv, Ukraine

Dr. Rositsa Krasteva; 🇧🇬 Ruse, Bulgaria

MHAT Shumen; 🇧🇬 Shumen, Bulgaria

UMHATSM N.I.Pirogov; 🇧🇬 Sofia, Bulgaria

Dr. Milcho Demerdziev; 🇲🇰 Skopje, North Macedonia

Dr. Justyna Hryniewicz; 🇵🇱 Plewiska, Poland

Dr. Marcin Ratajczak; 🇵🇱 Szczecin, Poland

Dr. Adriana Dulamea; 🇷🇴 Bucharest, Romania

Clinical Hospital Center Zemun; 🇷🇸 Belgrade, Serbia

Chernivtsi Medical Hospital; 🇺🇦 Chernivtsi, Ukraine

Dr. Larysa Sokolova; 🇺🇦 Kyiv, Ukraine

Prof. James Scott; 🇺🇸 Ormond Beach, Florida, United States