A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS (NCT07222956) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS
United States20 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Expanded Disability Status Score (EDSS) of 0 - 6.5, inclusive.
✓. Adequate vision and motor function to participate in assessment procedures.
✓. Females participating in the study must meet one the following criteria:
✓. Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year) or
Exclusion criteria
✕. 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.
What they're measuring
1
Quantitative MRI volumetric measurements
Timeframe: Baseline to Month 24
2
Slowly expanding lesions (SELs)
Timeframe: Baseline to Month 24
3
Paramagnetic rim lesions (PRLs) -- count
Timeframe: Baseline to Month 24
4
Paramagnetic rim lesions (PRLs) -- size
Timeframe: Baseline to Month 24
5
Paramagnetic rim lesions (PRLs) -- quantitative susceptibility measures