Multiple Sclerosis (MS) - Relapsing-remittingPhase 2RemiSevenNCT07222956
A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS
A Phase 2 study testing Remibrutinib (Open Label) in people with Multiple Sclerosis (MS) - Relapsing-remitting and Multiple Sclerosis (MS) Secondary Progressive, run by Moein Amin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Secondary Progressive, Multiple Sclerosis (MS) Primary Progressive
- What is being tested?
- Remibrutinib (Open Label)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 30 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible for the study, participants must meet the following eligibility criteria at the Screening visit:
- 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.
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- 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
- If not postmenopausal, agree to use a double method of contraception, one of which is a barrier method (e.g., intrauterine device plus condom, spermicidal gel plus condom) 30 days prior to dosing until 30 days after last dose and have negative human chorionic gonadotropin (β-hCG) test for pregnancy at screening and at each follow-up visit.
- Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) from 30 days prior to dosing until 30 days after last dose.
- Evidence of disease activity in the prior 12 months (at least one clinical relapse or one gadolinium enhancing lesion or new T2 lesion) or presence of disability worsening based clinician's assessment in the prior 12 months.
- Participants should be in reasonably good health and neurologically stable over the last 1 month (no MS relapse in this period).
Who cannot join
- Participants will be excluded from the study if any of the following exclusion criteria exist at the Screening Visit:
- 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:
- Acute or chronic liver disease ii. Cirrhosis iii. Any degree of hepatic impairment (i.e., mild, moderate, or severe) based on Child Pugh classification.
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- Untreated hepatitis C or active hepatitis B infection v. Alcohol intake greater than 2 drinks/day for men and greater than 1 drink per day for women vi. Transaminases (i.e., AST or ALT) > 1.5x the upper limit of normal (ULN) vii. Total bilirubin >1.5 x ULN viii. Alkaline phosphatase > 2x ULN unless caused by non-liver related disorder or explained by a stable chronic liver disorder
- 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.
- Active clinically significant bacterial, viral, parasitic, or fungal infections, in the judgement of the investigator.
- History of significant central nervous system disease (e.g. stroke, traumatic brain injury, myelopathy, progressive multifocal leukoencepahalopathy).
- History of splenectomy.
- History of active or latent tuberculosis with a positive QuantiFERON, at screening.
- Individuals with a known immunodeficiency syndrome, drug-induced immunodeficiency, hereditary immunodeficiency, or who test positive for Human immunodeficiency virus (HIV) antibody, at screening
- Clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, hematological, pulmonary, or gastrointestinal disorders that in the investigator's opinion would compromise the safety of the participant or interfere with the interpretation of the study results.
- History or current diagnosis of ECG abnormalities such as concomitant clinically significant cardiac arrhythmias, history of familial long QT syndrome, cardiac arrhythmias requiring anti-arrhythmic treatment with class Ia or III anti-arrhythmic drugs.
- Resting QT interval corrected by Fridericia's formula (QTcF) >450 msec (male) or >460 msec (female) prior to screening.
- Requirement for anticoagulant medication or use of dual anti-platelet therapy. Use of acetylsalicylic acid up to 100 mg/day or clopidogrel up to 75 mg/day, is permitted.
- Significant bleeding risk or history of clinically significant bleeding disorders.
- Use of gastric acid modifying agents, such as proton pump inhibitors or H2 antagonists.
- Use of any strong or moderate inhibitors of CYP3A4 (including clarithromycin, grapefruit, itraconazole, ketoconazole), or strong or moderate inducers of CYP3A4 (including carbamazepine, phenytoin, St John's Wort, primidone, modafinil). Use of BCRP or P-glycoprotein substrates. Use of any herbal/dietary supplements 8 weeks prior to first dose of study drug or during the study period. Concomitant medicines will be examined on a case-by-case basis against the Flockhart Table by study investigator, and if needed, the Medical Monitor, to determine allowability.
- Live vaccines within 6 weeks prior to screening or requirement to receive these vaccinations at any time during study treatment.
- Inability to complete MRI with contrast (claustrophobia, pacemaker, cochlear implant, metallic implants incompatible with MR, hypersensitivity to gadolinium-based contrast agent, or severe renal disease).
- Subjects who score "yes" to items 4 or 5 of the C-SSRS suicidal ideation or any of the items on C-SSRS suicidal behavior section at screening.
- Other factors that the Investigator determines would place the individual at risk for participation or interfere with interpretation of the results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic
Cleveland, Ohio, 44195
Bryan Davies, RN, 216-444-5253, daviesb@ccf.org
John Mays, 216-445-6339, maysj1@ccf.org
About this study
Official title: An Open-label, Single-center Study of Remibrutinib Using Ultra High-field (7T) MR Imaging in Relapsing or Progressive MS (RemiSeven)
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.
Read the detailed description
The study is an investigator-run, open-label Phase 2 study with approximately 24 total months of observation, involving approximately 20 participants with relapsing or progressive forms of MS.
Participants will be recruited from the patient populations followed at CCF. All participants will take 100 mg remibrutinib twice daily. They will receive 4 MRIs, blood tests, EKGs, physical exams, and clinical functioning exams periodically to assess safety, tolerability, and efficacy of the study drug. All study activities will be performed at the Cleveland Clinic Mellen Center.
- Conditions
- Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Secondary Progressive, Multiple Sclerosis (MS) Primary Progressive
- Being tested
- Remibrutinib (Open Label)
- Keywords
- multiple sclerosis, Relapsing, Progressive, Remibrutinib
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remibrutinib (Open Label)Drug
100 mg remibrutinib, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Remibrutinib, active administration | Experimental | 100 mg remibrutinib, twice daily Receives: Drug: Remibrutinib (Open Label) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative MRI volumetric measurements
Rate of change in regional brain volumes using 7T MRI over 24 months
Measured: Baseline to Month 24
Slowly expanding lesions (SELs)
Prevalence of SELs identified using 7T MRI over 24 months
Measured: Baseline to Month 24
Paramagnetic rim lesions (PRLs) -- count
Change in count of PRLs identified using 7T MRI over 24 months
Measured: Baseline to Month 24
Paramagnetic rim lesions (PRLs) -- size
Change in size of PRLs identified using 7T MRI over 24 months
Measured: Baseline to Month 24
Paramagnetic rim lesions (PRLs) -- quantitative susceptibility measures
Change in quantitative susceptibility measures of PRLs identified using 7T MRI over 24 months
Measured: Baseline to Month 24
Myelin Water Fraction
Rate of change in myelin water fraction assessed using 7T MRI over 24 months
Measured: Baseline to Month 24
Functional MRI (Default mode network)
Functional MRI changes (default mode network) assessed using 7T MRI over 24 months
Measured: Baseline to Month 24
Microstructural tissue integrity
Rate of change in microstructural tissue integrity assessed using 7T MRI over 24 months
Measured: Baseline to Month 24
Leptomeningeal enhancement
Prevalence of leptomeningeal enhancement identified using 7T MRI over 24 months
Measured: Baseline to Month 24
Neuromelanin
Prevalence of regional neuromelanin changes identified using 7T MRI over 24 months
Measured: Baseline to Month 24
Secondary outcomes (8)
Frequency of Treatment Emergent Adverse Events (TEAEs)
Measured: Baseline to Month 24
Frequency of Serious Adverse Events (SAEs)
Measured: Baseline to Month 24
Frequency of study medication discontinuation
Measured: Baseline to Month 24
Gadolinium Enhancing Lesions
Change in number of Gadolinium enhancing lesions over 24 months
Measured: Baseline to Month 24
Quantitative Lesion Burden
Change in the volume of brain lesions identified over 24 months
Measured: Baseline to Month 24
Annualized Relapse Rate (ARR)
Measured: Baseline to Month 24
Expanded Disability Status Scale (EDSS)
A scale from 0 to 10. An increase in EDSS score is indicative of an increase in disability
Measured: Baseline to Month 24
Serum Neurofilament Light Chain (NfL)
Measured: Baseline to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start1 Mar 2027 (estimated)
- Primary completion30 Oct 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS) - Relapsing-remittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- investigator-run, open-label
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moein Amin
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Moein Amin, The Cleveland Clinic
- Investigators
- Moein Amin, MD, MS, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222956
- Sponsor's protocol ID
- CCF 25-1070
- Acronym
- RemiSeven
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center Study of Remibrutinib Using Ultra High-field (7T) MR Imaging in Relapsing or Progressive MS (RemiSeven)
- ClinicalTrials.gov ID
- NCT07222956
- Acronym / sponsor ID
- RemiSeven / CCF 25-1070
- Conditions
- Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Secondary Progressive, Multiple Sclerosis (MS) Primary Progressive
- Keywords
- multiple sclerosis, Relapsing, Progressive, Remibrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Moein AminUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 30 Oct 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is an investigator-run, open-label Phase 2 study with approximately 24 total months of observation, involving approximately 20 participants with relapsing or progressive forms of MS.
Participants will be recruited from the patient populations followed at CCF. All participants will take 100 mg remibrutinib twice daily. They will receive 4 MRIs, blood tests, EKGs, physical exams, and clinical functioning exams periodically to assess safety, tolerability, and efficacy of the study drug. All study activities will be performed at the Cleveland Clinic Mellen Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- investigator-run, open-label
| Arm | Type | Receives |
|---|---|---|
| Remibrutinib, active administration | Experimental | Drug: Remibrutinib (Open Label)100 mg remibrutinib, twice daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- To be eligible for the study, participants must meet the following eligibility criteria at the Screening visit:
- 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.
Key exclusion criteria (27 listed)
- Participants will be excluded from the study if any of the following exclusion criteria exist at the Screening Visit:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remibrutinib (Open Label)100 mg remibrutinib, twice daily | Drug | Remibrutinib, active administration |
Primary outcome
Quantitative MRI volumetric measurements
Time frame: Baseline to Month 24
Rate of change in regional brain volumes using 7T MRI over 24 months
Slowly expanding lesions (SELs)
Time frame: Baseline to Month 24
Prevalence of SELs identified using 7T MRI over 24 months
Paramagnetic rim lesions (PRLs) -- count
Time frame: Baseline to Month 24
Change in count of PRLs identified using 7T MRI over 24 months
Paramagnetic rim lesions (PRLs) -- size
Time frame: Baseline to Month 24
Change in size of PRLs identified using 7T MRI over 24 months
Paramagnetic rim lesions (PRLs) -- quantitative susceptibility measures
Time frame: Baseline to Month 24
Change in quantitative susceptibility measures of PRLs identified using 7T MRI over 24 months
Myelin Water Fraction
Time frame: Baseline to Month 24
Rate of change in myelin water fraction assessed using 7T MRI over 24 months
Functional MRI (Default mode network)
Time frame: Baseline to Month 24
Functional MRI changes (default mode network) assessed using 7T MRI over 24 months
Microstructural tissue integrity
Time frame: Baseline to Month 24
Rate of change in microstructural tissue integrity assessed using 7T MRI over 24 months
Leptomeningeal enhancement
Time frame: Baseline to Month 24
Prevalence of leptomeningeal enhancement identified using 7T MRI over 24 months
Neuromelanin
Time frame: Baseline to Month 24
Prevalence of regional neuromelanin changes identified using 7T MRI over 24 months
8 secondary outcomes
Frequency of Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline to Month 24
Frequency of Serious Adverse Events (SAEs)
Time frame: Baseline to Month 24
Frequency of study medication discontinuation
Time frame: Baseline to Month 24
Gadolinium Enhancing Lesions
Time frame: Baseline to Month 24
Quantitative Lesion Burden
Time frame: Baseline to Month 24
Annualized Relapse Rate (ARR)
Time frame: Baseline to Month 24
Expanded Disability Status Scale (EDSS)
Time frame: Baseline to Month 24
Serum Neurofilament Light Chain (NfL)
Time frame: Baseline to Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moein Amin, MD, MS principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remibrutinib (Open Label) in people with Multiple Sclerosis (MS) - Relapsing-remitting and Multiple Sclerosis (MS) Secondary Progressive, run by Moein Amin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Planchon, MS, PhD (216-636-1232, planchs@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative MRI volumetric measurements (time frame: Baseline to Month 24). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.