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

NCT05054140 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: P2-IMU-838-PMS
• Study Type: interventional
• Target: 450
• Locations: 12 countries
• Sites: 73

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

Conditions

Multiple Sclerosis

Keywords

Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Efficacy of IMU-838 versus placebo

  Annualized rate of percent brain volume change (PBVC) during MT period

  120 weeks

Secondary Outcomes (2)

• Efficacy of IMU-838 versus placebo

  120 weeks

• Efficacy of IMU-838 versus placebo in terms of disability worsening

  120 weeks

Other Outcomes (1)

• Safety IMU-838 versus placebo

  120 weeks

Study Arms (2)

IMU-838

EXPERIMENTAL

IMU-838 as tablet; Administration: Oral - daily

Drug: IMU-838

Placebo

PLACEBO COMPARATOR

Matching placebo as tablet; Administration: Oral - daily

Drug: Placebo matching IMU-838

Interventions

IMU-838 DRUG

IMU-838 tablets

Also known as: Vidofludimus calcium

IMU-838

Placebo matching IMU-838 DRUG

Placebo matching IMU-838 tablets

Also known as: Placebo Arm

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunic AG: lead

Study Sites (73)

Dr. Sonia Kalirao

Coral Springs, Florida, 33067, United States

Location

Collier Neurologic Specialists

Naples, Florida, 34105, United States

Location

Prof. James Scott

Ormond Beach, Florida, 32174, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Consultants in Neurology, Ltd.

Northbrook, Illinois, 60062, United States

Location

Dr. Daniel Becker

Lutherville, Maryland, 21093, United States

Location

Dr. Mirela Cerghet

Detroit, Michigan, 48202, United States

Location

University of New Mexico (UNM), MS Specialty Clinic

Albuquerque, New Mexico, 87106, United States

Location

MHAT Pulse

Blagoevgrad, 2700, Bulgaria

Location

MHAT"Heart and Brain" EAD

Burgas, Bulgaria

Location

Dr. Maya Danovska

Pleven, 5800, Bulgaria

Location

Dr. Plamen Bozhinov

Pleven, 5804, Bulgaria

Location

UMHAT Pulmed

Plovdiv, Bulgaria

Location

Dr. Rositsa Krasteva

Rousse, 7003, Bulgaria

Location

Dr. Nikolay Georgiev

Shumen, 9700, Bulgaria

Location

MHAT Shumen

Shumen, 9705, Bulgaria

Location

Dr. Ivan Milanov

Sofia, 1113, Bulgaria

Location

MHAT Lyulin

Sofia, 1336, Bulgaria

Location

Dr. Rosen Ikonomov

Sofia, 1408, Bulgaria

Location

Dr. Penko Shotekov

Sofia, 1431, Bulgaria

Location

UMHAT Alexandrovska

Sofia, 1431, Bulgaria

Location

Dr. Kana Prinova

Sofia, 1606, Bulgaria

Location

Dr. Kosta Kostov

Sofia, 1606, Bulgaria

Location

MHAT Sveta Sofia

Sofia, Bulgaria

Location

UMHATSM N.I.Pirogov

Sofia, Bulgaria

Location

UMHAT Prof. Stoyan Kirkovich

Stara Zagora, Bulgaria

Location

Dr. Ara Kaprelyan

Varna, 9010, Bulgaria

Location

Montreal Neurological Inst.

Montreal, H3A 2B4, Canada

Location

The Ottawa Hospital Research Institute

Ottawa, K1H 8L6, Canada

Location

Fakultni nemocnice

Hradec Králové, Czechia

Location

Datamed GmbH

Cologne, 50935, Germany

Location

Klinik und Poliklinik für Neurologie, Universitätsklinikum Dresden

Dresden, 01307, Germany

Location

Neuro Centrum Science GmbH

Erbach im Odenwald, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20251, Germany

Location

Dr. Stanislav Groppa

Chisinau, 2004, Moldova

Location

Dr. Mihail Gavriliuc

Chisinau, 2028, Moldova

Location

Dr. Olesea Odainic

Chisinau, 2028, Moldova

Location

Dr. Eva Strijibis

Amsterdam, 1081BT, Netherlands

Location

Alrijne ziekenhuis

Leiderdorp, Netherlands

Location

Dr. Ana Doneva Skopje 1000

Skopje, 1000, North Macedonia

Location

Dr. Milcho Demerdziev

Skopje, 1000, North Macedonia

Location

Dr. Tatjana Boshkova

Skopje, 1000, North Macedonia

Location

Dr. Robert Bonek

Bydgoszcz, 85-796, Poland

Location

Dr. Maciej Maciejowski

Katowice, 40-571, Poland

Location

Dr. Janusz Zbrojkiewicz

Katowice, 40-686, Poland

Location

Dr. Elzbieta Jasinska

Kielce, 25-726, Poland

Location

Indywidualna Praktyka Lekarska Prof. Rejdak

Lublin, 20-016, Poland

Location

Dr. Marcin Nastaj

Lublin, 20-640, Poland

Location

Instytut Zdrowia

Oświęcim, Poland

Location

Dr. Justyna Hryniewicz

Plewiska, 62-064, Poland

Location

Clinical Research Center

Poznan, Poland

Location

EMC PL Certus

Poznan, Poland

Location

NZOZ "Neuro-kard"

Poznan, Poland

Location

Dr. Marcin Ratajczak

Szczecin, 70-111, Poland

Location

Warszawska Klinika

Warsaw, Poland

Location

EMC Instytut Medyczny

Wroclaw, Poland

Location

Dr. Adriana Dulamea

Bucharest, 22328, Romania

Location

Dr. Lacramioara Perju-Dumbrava

Cluj-Napoca, 400013, Romania

Location

Clinical Hospital Center Zemun

Belgrade, Serbia

Location

Military Medical Academy

Belgrade, Serbia

Location

Klinicki Centar Kragujevac

Kragujevac, 34000, Serbia

Location

Clinical center of Vojvodina

Novi Sad, Serbia

Location

Chernivtsi Medical Hospital

Chernivtsi, Ukraine

Location

Dr. Olena Moroz

Dnipro, 49000, Ukraine

Location

Dr. Pavlo Khaitov

Dnipro, 49128, Ukraine

Location

Dr. Tamara Mishchenko

Kharkiv, 61068, Ukraine

Location

Dr. Oleksandr Doroschenko

Krykhivtsi, 76493, Ukraine

Location

Dr. Larysa Sokolova

Kyiv, 03037, Ukraine

Location

Dr. Galusha

Kyiv, 04106, Ukraine

Location

Dr. Olga Shulga

Lutsk, 43005, Ukraine

Location

Dr.Tetyana Nehrych

Lviv, 79010, Ukraine

Location

Dr. Svitlana Skhrobot

Ternopil, 46024, Ukraine

Location

Dr. Sergii Moskovko

Vinnytsia, 21050, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert J. Fox, MD

  Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 23, 2021
• Study Start: September 30, 2021
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

CA (2); UA (11); MO (3); NL (2); US (8); RO (2); CZ (1); DE (4); PL (14); SE (4); BU (19); NO (3)