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

Phase 2

Active, not recruiting

• Conditions: Multiple Sclerosis
• Interventions: Drug: IMU-838; Drug: Placebo matching IMU-838

• Registration Number: NCT05054140
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-23
• Study Start: 2021-09-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Primary Completion: 2025-01-07
• Study Completion: 2025-01-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMU-838	IMU-838	IMU-838 as tablet; Administration: Oral - daily
Placebo	Placebo matching IMU-838	Matching placebo as tablet; Administration: Oral - daily

Primary Outcome Measures

Name	Time	Method
Efficacy of IMU-838 versus placebo	120 weeks	Annualized rate of percent brain volume change (PBVC) during MT period

Secondary Outcome Measures

Name	Time	Method
Efficacy of IMU-838 versus placebo in terms of disability worsening	120 weeks	Time to 24-week confirmed disability worsening based on expanded disability status scale (EDSS) during MT Period
Efficacy of IMU-838 versus placebo	120 weeks	Annualized rate of change in brain parenchymal fraction (BPF) during MT Period

Trial Locations

Locations (73)

Dr. Sonia Kalirao; 🇺🇸 Coral Springs, Florida, United States

Collier Neurologic Specialists; 🇺🇸 Naples, Florida, United States

Prof. James Scott; 🇺🇸 Ormond Beach, Florida, United States

Shepherd Center; 🇺🇸 Atlanta, Georgia, United States

Consultants in Neurology, Ltd.; 🇺🇸 Northbrook, Illinois, United States

Dr. Daniel Becker; 🇺🇸 Lutherville, Maryland, United States

Dr. Mirela Cerghet; 🇺🇸 Detroit, Michigan, United States

University of New Mexico (UNM), MS Specialty Clinic; 🇺🇸 Albuquerque, New Mexico, United States

MHAT Pulse; 🇧🇬 Blagoevgrad, Bulgaria

MHAT"Heart and Brain" EAD; 🇧🇬 Burgas, Bulgaria

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