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

  • STATUS
    Recruiting
  • End date
    Jul 28, 2024
  • participants needed
    450
  • sponsor
    Immunic AG
Updated on 3 May 2022
MRI
disease or disorder

Summary

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

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

Details
Condition Multiple Sclerosis
Treatment IMU-838, Placebo matching IMU-838
Clinical Study IdentifierNCT05054140
SponsorImmunic AG
Last Modified on3 May 2022

Eligibility

Yes No Not Sure

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
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

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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