Relapsing Multiple Sclerosis study: Remibrutinib oral treatment vs Ocrelizumab
Official title Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
ClinicalTrials.gov ID: NCT06846281
What this study is testing
What is Remibrutinib?
an investigational oral tablet being studied as a potential treatment for relapsing multiple sclerosis is designed to inhibit Bruton’s tyrosine kinase (BTK), which may affect immune cell activity involved in MS
Also referred to as LOU064.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how well remibrutinib works, how safe it is, and how well patients tolerate it after stopping ocrelizumab, compared with staying on ocrelizumab.
- Who it's for
- Adults with relapsing multiple sclerosis who are currently receiving ocrelizumab.
- What's involved
- Participants will either switch from ocrelizumab to remibrutinib or keep taking ocrelizumab, and will have regular clinic visits and tests to check disease activity and safety.
- Phase 3: a large, late-stage study
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70
You may be able to join if
- Male or female aged 40 to 70 years (inclusive)
- Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
- Treated with ocrelizumab according to routine clinical practice and at standard dose
- Neurologically stable within 30 days
- Suitable to be switched to remibrutinib based on physician judgement or patient preference Key
You likely can't join if
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
- History of clinically significant Central Nervous System disease or neurological disorders
- History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent
- Active clinically significant systemic bacterial, viral, parasitic or fungal infections
- Active, chronic disease of the immune system other than MS
- Severe cardiac disease or significant findings on the ECG
See the full eligibility criteria
- Male or female aged 40 to 70 years (inclusive)
- Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
- Treated with ocrelizumab according to routine clinical practice and at standard dose
- Neurologically stable within 30 days
- Suitable to be switched to remibrutinib based on physician judgement or patient preference Key
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
- History of clinically significant Central Nervous System disease or neurological disorders
- History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent
- Active clinically significant systemic bacterial, viral, parasitic or fungal infections
- Active, chronic disease of the immune system other than MS
- Severe cardiac disease or significant findings on the ECG
- Participant who is unable to undergo MRI scans
- History of life-threatening infusion or injection reaction related to ocrelizumab
- Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening) Other inclusion and exclusion criteria may apply
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Irvine, California, United States
- Washington D.C., District of Columbia, United States
- Altamonte Springs, Florida, United States
- Gainesville, Florida, United States
- Hollywood, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Naples, Florida, United States
- Orlando, Florida, United States
- Tallahassee, Florida, United States
- Tampa, Florida, United States
- Vero Beach, Florida, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Olney, Maryland, United States
- Burlington, Massachusetts, United States
- Foxborough, Massachusetts, United States
- Farmington Hills, Michigan, United States
- Owosso, Michigan, United States
+ 98 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Irvine, California, United States; Washington D.C., District of Columbia, United States; Altamonte Springs, Florida, United States; Gainesville, Florida, United States; Hollywood, Florida, United States and 112 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.