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

Sponsor
Immunic AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05054140
Collaborator
(none)
450
Enrollment
63
Locations
2
Arms
33.9
Anticipated Duration (Months)
7.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
Actual Study Start Date :
Sep 30, 2021
Anticipated Primary Completion Date :
Apr 5, 2024
Anticipated Study Completion Date :
Jul 28, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of IMU-838 versus placebo [24 weeks]

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

    2. Efficacy IMU-838 versus placebo [24 weeks]

      Time to 24-week confirmed disability progression based on expanded disability status scale (EDSS) during the MT period

    Secondary Outcome Measures

    1. Safety IMU-838 versus placebo [24 weeks]

      Adverse events (AEs) and serious AEs (SAEs)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Los Angeles County Harbor UCLA, Medical Center and Lundquist Institute Torrance California United States 90504
    2 Dr. Sonia Kalirao Coral Springs Florida United States 33067
    3 Collier Neurologic Specialists Naples Florida United States 34105
    4 Prof. James Scott Ormond Beach Florida United States 32174
    5 Consultants in Neurology, Ltd. Northbrook Illinois United States 60062
    6 Prof. George Katsamakis Rolling Meadows Illinois United States 60008
    7 Dr. Daniel Becker Lutherville Maryland United States 21093
    8 Dr. Mirela Cerghet Detroit Michigan United States 48202
    9 University of New Mexico (UNM), MS Specialty Clinic Albuquerque New Mexico United States 87106
    10 MHAT Pulse Blagoevgrad Bulgaria 2700
    11 Dr. Maya Danovska Pleven Bulgaria 5800
    12 Dr. Plamen Bozhinov Pleven Bulgaria 5804
    13 Dr. Rositsa Krasteva Ruse Bulgaria 7003
    14 Dr. Nikolay Georgiev Shumen Bulgaria 9700
    15 MHAT Shumen Shumen Bulgaria 9705
    16 Dr. Ivan Milanov Sofia Bulgaria 1113
    17 Dr. Rosen Ikonomov Sofia Bulgaria 1408
    18 Dr. Penko Shotekov Sofia Bulgaria 1431
    19 UMHAT Alexandrovska Sofia Bulgaria 1431
    20 Dr. Kana Prinova Sofia Bulgaria 1606
    21 Dr. Kosta Kostov Sofia Bulgaria 1606
    22 Dr. Ara Kaprelyan Varna Bulgaria 9010
    23 Montreal Neurological Inst. Montréal Canada H3A 2B4
    24 The Ottawa Hospital Research Institute Ottawa Canada K1H 8L6
    25 Klinikum Bayreuth GmbH Bayreuth Germany 95445
    26 Klinik und Poliklinik für Neurologie, Universitätsklinikum Dresden Dresden Germany 01307
    27 Universitätsklinikum Hamburg Eppendorf Hamburg Germany 20251
    28 Datamed GmbH Köln Germany 50935
    29 Universitätsklinikum Münster, Klinik für Neurologie Münster Germany 48149
    30 Dr. Stanislav Groppa Chisinau Moldova, Republic of 2004
    31 Dr. Mihail Gavriliuc Chisinau Moldova, Republic of 2028
    32 Dr. Olesea Odainic Chisinau Moldova, Republic of 2028
    33 Dr. Eva Strijibis Amsterdam Netherlands 1081BT
    34 Dr. Ana Doneva Skopje 1000 Skopje North Macedonia 1000
    35 Dr. Milcho Demerdziev Skopje North Macedonia 1000
    36 Dr. Tatjana Boshkova Skopje North Macedonia 1000
    37 Dr. Robert Bonek Bydgoszcz Poland 85-796
    38 Dr. Maciej Maciejowski Katowice Poland 40-571
    39 Dr. Janusz Zbrojkiewicz Katowice Poland 40-686
    40 Dr. Elzbieta Jasinska Kielce Poland 25-726
    41 Indywidualna Praktyka Lekarska Prof. Rejdak Lublin Poland 20-016
    42 Dr. Marcin Nastaj Lublin Poland 20-640
    43 Dr. Justyna Hryniewicz Plewiska Poland 62-064
    44 Dr. Marcin Ratajczak Szczecin Poland 70-111
    45 Dr. Cristina Panea Bucharest Romania 11461
    46 Dr. Adriana Dulamea Bucharest Romania 22328
    47 Dr. Lacramioara Perju-Dumbrava Cluj-Napoca Romania 400013
    48 Dr. Ana Maria Ionescu Constanta Romania 900123
    49 Dr. Steliana Halmagean Timisoara Romania 300425
    50 Klinicki Centar Kragujevac Kragujevac Serbia 34000
    51 Dr. Olena Moroz Dnipro Ukraine 49000
    52 Dr. Pavlo Khaitov Dnipro Ukraine 49128
    53 Dr. Tamara Mishchenko Kharkiv Ukraine 61068
    54 Dr. Hanna Hostieva Kherson Ukraine 73003
    55 Dr. Oleksandr Doroschenko Krykhivtsi Ukraine 76493
    56 Dr. Larysa Sokolova Kyiv Ukraine 03037
    57 Dr. Galusha Kyiv Ukraine 04106
    58 Dr. Olga Shulga Lutsk Ukraine 43005
    59 Dr.Tetyana Nehrych Lviv Ukraine 79010
    60 Dr. Svitlana Skhrobot Ternopil Ukraine 46024
    61 Dr. Sergii Moskovko Vinnytsya Ukraine 21050
    62 Dr. Nataliya Tomakh Zaporizhzhya Ukraine 69035
    63 Dr. Nataliia Buchakchyska Zaporizhzhya Ukraine 69600

    Sponsors and Collaborators

    • Immunic AG

    Investigators

    • Principal Investigator: R. F., MD, University Cleveland Ohio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Immunic AG
    ClinicalTrials.gov Identifier:
    NCT05054140
    Other Study ID Numbers:
    • P2-IMU-838-PMS
    First Posted:
    Sep 23, 2021
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Immunic AG
    Progressive Multiple Sclerosis
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Chronic Progressive
    Sclerosis
    Calcium

    Study Results

    No Results Posted as of Aug 1, 2022