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

• ClinicalTrials.gov Identifier: NCT05054140
• Recruitment Status: Active, not recruiting
• First Posted: September 23, 2021
• Last Update Posted: April 29, 2024
• Sponsor: Immunic AG
• Information provided by (Responsible Party): Immunic AG

Tracking Information

• First Submitted Date: September 2, 2021
• First Posted Date: September 23, 2021
• Last Update Posted Date: April 29, 2024
• Actual Study Start Date: September 30, 2021
• Estimated Primary Completion Date: January 7, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 22, 2023)

Efficacy of IMU-838 versus placebo [ Time Frame: 120 weeks ]

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

Original Primary Outcome Measures (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

Current Secondary Outcome Measures (submitted: December 22, 2023)

• Efficacy of IMU-838 versus placebo [ Time Frame: 120 weeks ]
  Annualized rate of change in brain parenchymal fraction (BPF) during MT Period
• 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

Original Secondary Outcome Measures (submitted: September 13, 2021)

Safety IMU-838 versus placebo [ Time Frame: 24 weeks ]

Adverse events (AEs) and serious AEs (SAEs)

Current Other Pre-specified Outcome Measures (submitted: December 22, 2023)

Safety IMU-838 versus placebo [ Time Frame: 120 weeks ]

Adverse events (AEs) and serious AEs (SAEs) during MT Period

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Multiple Sclerosis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 13, 2021): 450
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 7, 2025
• Estimated Primary Completion Date: January 7, 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Canada, Czechia, Germany, Moldova, Republic of, Netherlands, North Macedonia, Poland, Romania, Serbia, Ukraine, United States

Administrative Information

• NCT Number: NCT05054140
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Immunic AG
• Original Responsible Party: Same as current
• Current Study Sponsor: Immunic AG
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Immunic AG
• Verification Date: April 2024