A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib
Efficacy and Safety of Remibrutinib After Switching from Ocrelizumab
Plain English Summary
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. is a Phase 3 clinical trial sponsored by Novartis Pharmaceuticals studying Relapsing Multiple Sclerosis. This trial compares the effectiveness and safety of switching from ocrelizumab to remibrutinib in treating relapsing multiple sclerosis. Participants must be between 40 and 70 years old, have relapsing multiple sclerosis, and be stable on ocrelizumab. The trial involves taking a daily tablet of remibrutinib or continuing ocrelizumab infusions. Alternative treatments include continuing ocrelizumab or other MS medications. The trial aims to enroll 360 participants.
Official Summary
The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible participants are adults aged 40 to 70 with relapsing multiple sclerosis who have been on ocrelizumab. Those with primary progressive MS, severe infections, or heart issues are not eligible. Participants must be neurologically stable and suitable for switching to remibrutinib. Exclusion criteria include history of certain neurological disorders or active infections. This trial is studying Relapsing Multiple Sclerosis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures the rate of new or enlarging T2 lesions, which helps patients understand if the treatment is reducing their MS activity. The specific primary outcome measures are: Annualized rate of new or enlarging T2 lesions_Core Part (Baseline up to month 24). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a significant gap in treatment options for relapsing multiple sclerosis by evaluating a new drug that could offer an alternative to ocrelizumab. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Relapsing Multiple Sclerosis, where improved treatment options are needed.
Investor Insight
The large market size and competitive landscape suggest a high probability of approval, making this a promising investment opportunity. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if you meet the age and health requirements for the trial. Daily participation involves taking a tablet of remibrutinib or continuing ocrelizumab infusions. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 360 participants
Interventions
- DRUG: Remibrutinib oral treatment — Remibrutinib tablet taken daily
- DRUG: Ocrelizumab — Ocrelizumab 600mg infusion or 920mg injection
Primary Outcomes
- Annualized rate of new or enlarging T2 lesions_Core Part (Baseline up to month 24)
Secondary Outcomes
- Participants with no evidence of disease activity-3 (NEDA-3)_Core Part (Baseline up to month 24)
- Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part (Baseline up to month 24)
- Annualized rate of new or enlarging T2 lesions_Extension Part (Month 24 up to month 48)
- Participants with no evidence of disease activity-3 (NEDA-3)_Extension Part (Month 24 up to month 48)
- Number of Adverse events and serious adverse events_Extension Part (Month 24 up to month 48)
Full Eligibility Criteria
Key Inclusion 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 Exclusion Criteria: * 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 Other inclusion and exclusion criteria may apply
Trial Locations
- Perseverance Research Center, Scottsdale, Arizona, United States
- Medstar Washington Hospital Center, Washington D.C., District of Columbia, United States
- Neurology of Central FL Res Ctr, Altamonte Springs, Florida, United States
- University of Florida, Gainesville, Florida, United States
- Neurology Associates PA, Maitland, Florida, United States
- Aqualane Clinical Research, Naples, Florida, United States
- Orlando Health Clinical Trials, Orlando, Florida, United States
- Tallahassee Neurological Clinic, Tallahassee, Florida, United States
- University Of South Florida, Tampa, Florida, United States
- Vero Beach Neurology, Vero Beach, Florida, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06846281?
NCT06846281 is a Phase 3 INTERVENTIONAL study titled "Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.." It is currently recruiting and is sponsored by Novartis Pharmaceuticals. The trial targets enrollment of 360 participants.
What conditions does NCT06846281 study?
This trial investigates treatments for Relapsing Multiple Sclerosis. The primary condition under study is Relapsing Multiple Sclerosis.
What treatments are being tested in NCT06846281?
The interventions being studied include: Remibrutinib oral treatment (DRUG), Ocrelizumab (DRUG). Remibrutinib tablet taken daily
What does Phase 3 mean for NCT06846281?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06846281?
This trial is currently "Recruiting." It started on 2025-07-23. The estimated completion date is 2031-06-20.
Who is sponsoring NCT06846281?
NCT06846281 is sponsored by Novartis Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06846281?
The trial aims to enroll 360 participants. The trial is currently recruiting and accepting new participants.
How is NCT06846281 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06846281?
The primary outcome measures are: Annualized rate of new or enlarging T2 lesions_Core Part (Baseline up to month 24). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06846281 being conducted?
This trial is being conducted at 20 sites, including Scottsdale, Arizona; Washington D.C., District of Columbia; Altamonte Springs, Florida; Gainesville, Florida and 16 more sites (United States).
Where can I find official information about NCT06846281?
The official record for NCT06846281 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06846281. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06846281 testing in simple terms?
This trial compares the effectiveness and safety of switching from ocrelizumab to remibrutinib in treating relapsing multiple sclerosis. Participants must be between 40 and 70 years old, have relapsing multiple sclerosis, and be stable on ocrelizumab.
Why is this trial significant?
This trial addresses a significant gap in treatment options for relapsing multiple sclerosis by evaluating a new drug that could offer an alternative to ocrelizumab. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06846281?
Key risks include potential side effects such as infections and allergic reactions. Participants should be aware of the need for regular MRI scans and medical follow-ups. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06846281?
Ask your doctor if you meet the age and health requirements for the trial. Daily participation involves taking a tablet of remibrutinib or continuing ocrelizumab infusions. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06846281 signal from an investment perspective?
The large market size and competitive landscape suggest a high probability of approval, making this a promising investment opportunity. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
The trial involves taking a daily tablet of remibrutinib or continuing ocrelizumab infusions. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.