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 2026-06-30
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 range
18 Years – 60 Years
Sex
ALL
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. History of liver disease or liver function abnormalities at baseline including Gilbert syndrome:
. History of severe renal disease or creatinine level above 1.5 x upper limit normal.
. Pregnancy, planned or current.
. History of severe depression or suicidality.
. Hematological abnormalities at screening: hemoglobin \< 10 g/dl, platelets \< 100000/mm3, absolute lymphocyte count \< 800/mm3, white blood cells \< 3000/mm3, neutrophils \< 1500/mm3, B-cell count \< 50% lower limit of normal, total IgG or total IgM \< lower limit of normal.