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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

Tracking Information
First Submitted Date  ICMJE September 2, 2021
First Posted Date  ICMJE September 23, 2021
Last Update Posted Date October 29, 2021
Actual Study Start Date  ICMJE September 30, 2021
Estimated Primary Completion Date April 5, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2021)
  • Efficacy of IMU-838 versus placebo [ Time Frame: 24 weeks ]
    Annualized rate of percent brain volume change (PBVC) during MT period
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2021)
Safety IMU-838 versus placebo [ Time Frame: 24 weeks ]
Adverse events (AEs) and serious AEs (SAEs)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
Official Title  ICMJE Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: IMU-838
    IMU-838 tablets
    Other Name: Vidofludimus calcium
  • Drug: Placebo matching IMU-838
    Placebo matching IMU-838 tablets
    Other Name: Placebo Arm
Study Arms  ICMJE
  • Experimental: IMU-838
    IMU-838 as tablet; Administration: Oral - daily
    Intervention: Drug: IMU-838
  • Placebo Comparator: Placebo
    Matching placebo as tablet; Administration: Oral - daily
    Intervention: Drug: Placebo matching IMU-838
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2021)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 28, 2024
Estimated Primary Completion Date April 5, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andreas Muehler, MD +49 89 2080 477 00 info@imux.com
Listed Location Countries  ICMJE Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05054140
Other Study ID Numbers  ICMJE P2-IMU-838-PMS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Immunic AG
Study Sponsor  ICMJE Immunic AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: R. F., MD University Cleveland Ohio
PRS Account Immunic AG
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP