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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 23, 2021
Last Update Posted : April 29, 2024
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Sponsor:
Immunic AG
Information provided by (Responsible Party):
Immunic AG
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Sclerosis | Drug: IMU-838 Drug: Placebo matching IMU-838 | Phase 2 |
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 (Clinical Trial) |
| Estimated Enrollment : | 450 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis |
| Actual Study Start Date : | September 30, 2021 |
| Estimated Primary Completion Date : | January 7, 2025 |
| Estimated Study Completion Date : | January 7, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: IMU-838
IMU-838 as tablet; Administration: Oral - daily
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Drug: IMU-838
IMU-838 tablets
Other Name: Vidofludimus calcium |
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Placebo Comparator: Placebo
Matching placebo as tablet; Administration: Oral - daily
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Drug: Placebo matching IMU-838
Placebo matching IMU-838 tablets
Other Name: Placebo Arm |
Primary Outcome Measures :
- Efficacy of IMU-838 versus placebo [ Time Frame: 120 weeks ]Annualized rate of percent brain volume change (PBVC) during MT period
Secondary Outcome Measures :
- 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
Other Outcome Measures:
- Safety IMU-838 versus placebo [ Time Frame: 120 weeks ]Adverse events (AEs) and serious AEs (SAEs) during MT Period
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, age 18 to 65 years (inclusive).
- EDSS score at screening between 3.0 to 6.5 (both inclusive)
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05054140
Locations
Show 73 study locations
Sponsors and Collaborators
Immunic AG
Investigators
| Principal Investigator: | Robert J. Fox, MD | Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio |
| Responsible Party: | Immunic AG |
| ClinicalTrials.gov Identifier: | NCT05054140 |
| Other Study ID Numbers: |
P2-IMU-838-PMS |
| First Posted: | September 23, 2021 Key Record Dates |
| Last Update Posted: | April 29, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Immunic AG:
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Progressive Multiple Sclerosis |
Additional relevant MeSH terms:
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Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Chronic Disease Disease Attributes Calcium Calcium-Regulating Hormones and Agents Physiological Effects of Drugs |