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

April 26, 2024 updated by: Immunic AG

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • MHAT Pulse
      • Burgas, Bulgaria
        • MHAT"Heart and Brain" EAD
      • Pleven, Bulgaria, 5800
        • Dr. Maya Danovska
      • Pleven, Bulgaria, 5804
        • Dr. Plamen Bozhinov
      • Plovdiv, Bulgaria
        • UMHAT Pulmed
      • Ruse, Bulgaria, 7003
        • Dr. Rositsa Krasteva
      • Shumen, Bulgaria, 9700
        • Dr. Nikolay Georgiev
      • Shumen, Bulgaria, 9705
        • MHAT Shumen
      • Sofia, Bulgaria, 1336
        • MHAT Lyulin
      • Sofia, Bulgaria, 1113
        • Dr. Ivan Milanov
      • Sofia, Bulgaria, 1408
        • Dr. Rosen Ikonomov
      • Sofia, Bulgaria, 1431
        • Dr. Penko Shotekov
      • Sofia, Bulgaria, 1431
        • UMHAT Alexandrovska
      • Sofia, Bulgaria, 1606
        • Dr. Kana Prinova
      • Sofia, Bulgaria, 1606
        • Dr. Kosta Kostov
      • Sofia, Bulgaria
        • MHAT Sveta Sofia
      • Sofia, Bulgaria
        • UMHATSM N.I.Pirogov
      • Stara Zagora, Bulgaria
        • UMHAT Prof. Stoyan Kirkovich
      • Varna, Bulgaria, 9010
        • Dr. Ara Kaprelyan
  • Canada
      • Montréal, Canada, H3A 2B4
        • Montreal Neurological Inst.
      • Ottawa, Canada, K1H 8L6
        • The Ottawa Hospital Research Institute
  • Czechia
      • Hradec Králové, Czechia
        • Fakultní nemocnice
  • Germany
      • Dresden, Germany, 01307
        • Klinik und Poliklinik für Neurologie, Universitätsklinikum Dresden
      • Erbach, Germany
        • Neuro Centrum Science GmbH
      • Hamburg, Germany, 20251
        • Universitatsklinikum Hamburg Eppendorf
      • Köln, Germany, 50935
        • Datamed GmbH
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, 2004
        • Dr. Stanislav Groppa
      • Chisinau, Moldova, Republic of, 2028
        • Dr. Mihail Gavriliuc
      • Chisinau, Moldova, Republic of, 2028
        • Dr. Olesea Odainic
  • Netherlands
      • Amsterdam, Netherlands, 1081BT
        • Dr. Eva Strijibis
      • Leiderdorp, Netherlands
        • Alrijne Ziekenhuis
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Dr. Ana Doneva Skopje 1000
      • Skopje, North Macedonia, 1000
        • Dr. Milcho Demerdziev
      • Skopje, North Macedonia, 1000
        • Dr. Tatjana Boshkova
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Dr. Robert Bonek
      • Katowice, Poland, 40-571
        • Dr. Maciej Maciejowski
      • Katowice, Poland, 40-686
        • Dr. Janusz Zbrojkiewicz
      • Kielce, Poland, 25-726
        • Dr. Elzbieta Jasinska
      • Lublin, Poland, 20-016
        • Indywidualna Praktyka Lekarska Prof. Rejdak
      • Lublin, Poland, 20-640
        • Dr. Marcin Nastaj
      • Oświęcim, Poland
        • Instytut Zdrowia
      • Plewiska, Poland, 62-064
        • Dr. Justyna Hryniewicz
      • Poznań, Poland
        • Clinical Research Center
      • Poznań, Poland
        • EMC PL Certus
      • Poznań, Poland
        • NZOZ "Neuro-kard"
      • Szczecin, Poland, 70-111
        • Dr. Marcin Ratajczak
      • Warsaw, Poland
        • Warszawska Klinika
      • Wrocław, Poland
        • EMC Instytut Medyczny
  • Romania
      • Bucharest, Romania, 22328
        • Dr. Adriana Dulamea
      • Cluj-Napoca, Romania, 400013
        • Dr. Lacramioara Perju-Dumbrava
  • Serbia
      • Belgrade, Serbia
        • Military Medical Academy
      • Belgrade, Serbia
        • Clinical Hospital Center Zemun
      • Kragujevac, Serbia, 34000
        • Klinički centar Kragujevac
      • Novi Sad, Serbia
        • Clinical Center of Vojvodina
  • Ukraine
      • Chernivtsi, Ukraine
        • Chernivtsi Medical Hospital
      • Dnipro, Ukraine, 49000
        • Dr. Olena Moroz
      • Dnipro, Ukraine, 49128
        • Dr. Pavlo Khaitov
      • Kharkiv, Ukraine, 61068
        • Dr. Tamara Mishchenko
      • Krykhivtsi, Ukraine, 76493
        • Dr. Oleksandr Doroschenko
      • Kyiv, Ukraine, 03037
        • Dr. Larysa Sokolova
      • Kyiv, Ukraine, 04106
        • Dr. Galusha
      • Lutsk, Ukraine, 43005
        • Dr. Olga Shulga
      • Lviv, Ukraine, 79010
        • Dr.Tetyana Nehrych
      • Ternopil, Ukraine, 46024
        • Dr. Svitlana Skhrobot
      • Vinnytsya, Ukraine, 21050
        • Dr. Sergii Moskovko
  • United States
    • Florida
      • Coral Springs, Florida, United States, 33067
        • Dr. Sonia Kalirao
      • Naples, Florida, United States, 34105
        • Collier Neurologic Specialists
      • Ormond Beach, Florida, United States, 32174
        • Prof. James Scott
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Consultants in Neurology, Ltd.
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Dr. Daniel Becker
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Dr. Mirela Cerghet
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico (UNM), MS Specialty Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMU-838
IMU-838 as tablet; Administration: Oral - daily
Drug: IMU-838
IMU-838 tablets
Other Names:
  • Vidofludimus calcium
Placebo Comparator: Placebo
Matching placebo as tablet; Administration: Oral - daily
Drug: Placebo matching IMU-838
Placebo matching IMU-838 tablets
Other Names:
  • Placebo Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of IMU-838 versus placebo
Time Frame: 120 weeks
Annualized rate of percent brain volume change (PBVC) during MT period
120 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety IMU-838 versus placebo
Time Frame: 120 weeks
Adverse events (AEs) and serious AEs (SAEs) during MT Period
120 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunic AG

Investigators

  • Principal Investigator: Robert J. Fox, MD, Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Estimated)

January 7, 2025

Study Completion (Estimated)

January 7, 2025

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2-IMU-838-PMS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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