A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMoein Amin

About this trial

The study is an investigator-run, study following participants for 2 years with twice-daily remibrutinib. MRI is the main endpoint. Safety, tolerability, and efficacy are secondary endpoints. Approximately 20 participants with relapsing or progressive forms of MS will be recruited.

Eligibility criteria

Qualifiers

Written informed consent signed by participant.

English-speaking.

Male and female participants, 18-60 years of age inclusive.

Established diagnosis of relapsing or progressive MS, as defined by the 2024 revision of McDonald Diagnostic Criteria (any form of MS). A diagnosis of MS must be confirmed at the time of the screening visit.

Disqualifiers

Concurrent treatment with any disease modifying therapy for MS or systemic immunotherapy for other autoimmune or rheumatological disorders (e.g. rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease) according to study protocol.

Ongoing substance abuse (drug or alcohol) or any other factor that may interfere with the participant's ability to cooperate and comply with study procedures.

History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer) within the past 5 years regardless of treatment or metastasis status.

History of severe renal disease or creatinine level above 1.5 x upper limit normal.

Trial design

Treatments tested in this trial

  • Remibrutinib (Open Label)

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Moein Amin

Lead sponsor

The Cleveland Clinic

Sponsor institution

Novartis Pharmaceuticals

Collaborator