Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Multiple Sclerosis
In brief
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER
Key facts
- Study ID
- NCT05054140
- Run by
- Immunic AG
- People needed
- 450
- Starts
- 2021-09-30
- Expected to finish
- 2025-01-07
- Last updated by the study team
- 2024-04-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- 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
You may not qualify if…
- 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.
Where it is running
- 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
- Dr. Maya Danovska — Pleven, Bulgaria
- Dr. Plamen Bozhinov — Pleven, Bulgaria
- UMHAT Pulmed — Plovdiv, Bulgaria
- Dr. Rositsa Krasteva — Rousse, Bulgaria
- Dr. Nikolay Georgiev — Shumen, Bulgaria
- MHAT Shumen — Shumen, Bulgaria
- Dr. Ivan Milanov — Sofia, Bulgaria
- MHAT Lyulin — Sofia, Bulgaria
- Dr. Rosen Ikonomov — Sofia, Bulgaria
- Dr. Penko Shotekov — Sofia, Bulgaria
- UMHAT Alexandrovska — Sofia, Bulgaria
- Dr. Kana Prinova — Sofia, Bulgaria
- Dr. Kosta Kostov — Sofia, Bulgaria
- MHAT Sveta Sofia — Sofia, Bulgaria
- Dr. Justyna Hryniewicz — Plewiska, Poland
Full record on ClinicalTrials.gov
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