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

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ClinicalTrials.gov Identifier: NCT05054140
Recruitment Status : Recruiting
First Posted : September 23, 2021
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: IMU-838 Drug: Placebo matching IMU-838 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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 30, 2021
Estimated Primary Completion Date : April 5, 2024
Estimated Study Completion Date : July 28, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IMU-838
IMU-838 as tablet; Administration: Oral - daily
Drug: IMU-838
IMU-838 tablets
Other Name: Vidofludimus calcium

Placebo Comparator: Placebo
Matching placebo as tablet; Administration: Oral - daily
Drug: Placebo matching IMU-838
Placebo matching IMU-838 tablets
Other Name: Placebo Arm




Primary Outcome Measures :
  1. Efficacy of IMU-838 versus placebo [ Time Frame: 24 weeks ]
    Annualized rate of percent brain volume change (PBVC) during MT period

  2. Efficacy IMU-838 versus placebo [ Time Frame: 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 [ Time Frame: 24 weeks ]
    Adverse events (AEs) and serious AEs (SAEs)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05054140


Contacts
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Contact: Andreas Muehler, MD +49 89 2080 477 00 info@imux.com

Locations
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Ukraine
University Ukraine Recruiting
Kryvyi Rih, Ukraine, 76493
Sponsors and Collaborators
Immunic AG
Investigators
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Principal Investigator: R. F., MD University Cleveland Ohio
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Responsible Party: Immunic AG
ClinicalTrials.gov Identifier: NCT05054140    
Other Study ID Numbers: P2-IMU-838-PMS
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021

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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:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs