Multiple Sclerosis
Conditions
Keywords
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
Interventions
DRUGIMU-838
IMU-838 tablets
DRUGPlacebo matching IMU-838
Placebo matching IMU-838 tablets
Sponsors
Immunic AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of IMU-838 versus placebo | 120 weeks | Annualized rate of percent brain volume change (PBVC) during MT period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of IMU-838 versus placebo | 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 | 120 weeks | Time to 24-week confirmed disability worsening based on expanded disability status scale (EDSS) during MT Period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety IMU-838 versus placebo | 120 weeks | Adverse events (AEs) and serious AEs (SAEs) during MT Period |
Countries
Bulgaria, Canada, Czechia, Germany, Moldova, Netherlands, North Macedonia, Poland, Romania, Serbia, Ukraine, United States
Outcome results
None listed