Remibrutinib for Multiple Sclerosis

Recruiting at 25 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must be taking: Ocrelizumab

Disqualifiers: Primary progressive MS, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called remibrutinib for individuals with relapsing multiple sclerosis (RMS), a condition where the immune system attacks the brain and spinal cord. The study compares the effectiveness of remibrutinib to another treatment, ocrelizumab, focusing on those switching from ocrelizumab. It also evaluates the safety and tolerability of remibrutinib. Individuals who have been on ocrelizumab, are stable in their condition, and are ready to try remibrutinib might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment option.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves switching from ocrelizumab to remibrutinib, you may need to stop ocrelizumab under your doctor's guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that remibrutinib is generally safe for use in various diseases. Studies have found it to be well-tolerated, even at doses of 100 mg twice a day, meaning most people do not experience serious side effects.

For those considering joining a trial, it is important to know that remibrutinib is being tested for various uses, with safety data supporting its application. Ongoing research aims to ensure that remibrutinib remains safe and effective for individuals with conditions like relapsing multiple sclerosis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple sclerosis?

Unlike the standard treatments for multiple sclerosis, which often involve injections or infusions, Remibrutinib is taken orally as a tablet, offering potentially greater convenience and ease of use. Researchers are excited about Remibrutinib because it targets Bruton’s tyrosine kinase (BTK), a novel approach that may help reduce disease activity by modulating the immune system more precisely. This targeted action could lead to fewer side effects compared to broader-acting therapies like Ocrelizumab, which is administered via infusion.

What evidence suggests that this trial's treatments could be effective for multiple sclerosis?

Research has shown that remibrutinib might effectively treat relapsing multiple sclerosis (RMS). Studies have found that remibrutinib can reduce brain swelling without directly affecting certain immune cells, such as B cells and T cells. This suggests it might help control the immune system's attack on the nervous system, a major issue in multiple sclerosis. In previous studies, patients with RMS responded well to remibrutinib compared to teriflunomide. This trial will compare remibrutinib with ocrelizumab, offering a promising new approach to managing RMS, distinct from traditional methods. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people over 40 with relapsing multiple sclerosis (RMS), who have been treated with ocrelizumab and are neurologically stable. They should be able to perform daily activities (EDSS score of 0-6.5) and can switch medications based on their doctor's advice or personal preference.

Inclusion Criteria

I am 40 years old or older.

I have been diagnosed with RMS according to the 2017 criteria.

I am being treated with ocrelizumab at the standard dose.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Part

Participants receive either remibrutinib or ocrelizumab treatment for relapsing multiple sclerosis

24 months

Regular visits as per protocol

Extension Part

Participants who completed the Core Part continue with remibrutinib treatment in an open-label, single-arm design

24 months

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remibrutinib

Trial Overview The study compares the effectiveness and safety of switching from ocrelizumab to an oral treatment called remibrutinib, versus continuing on ocrelizumab. It's a Phase 3b trial for those living with RMS, aiming to see if changing treatments can improve outcomes.

How Is the Trial Designed?

Group I: Remibrutinib Extension (Ocrelizumab in Core) Experimental Treatment 1 Intervention

Remibrutinib tablet taken orally

Group II: Remibrutinib Extension Experimental Treatment 1 Intervention

Remibrutinib tablet taken orally

Group III: Remibrutinib Core Experimental Treatment 1 Intervention

Remibrutinib tablet taken orally

Group IV: Ocrelizumab Core Active Control 1 Intervention

Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06846281

NCT06846281 | Efficacy and Safety of Remibrutinib After ... The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to ...

2. novartis.com novartis.com/clinicaltrials/study/nct05147220

Efficacy and Safety of Remibrutinib Compared to ... To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034823008167

Phase 3 REMODEL I/II Trials: Efficacy, Safety, and ... The REMODEL I and II studies will investigate the efficacy, safety, and tolerability of remibrutinib versus teriflunomide to support regulatory approval ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10463946/

Remibrutinib (LOU064) inhibits neuroinflammation driven by B ... Remibrutinib showed efficacy in both models in absence of direct B cell depletion, broad T cell inhibition or reduction of total Ig levels.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12052076/

Update on novel multiple sclerosis treatments - PubMed Central The study of tolebrutinib in nrSPMS met its primary endpoint on prevention of CDP and showed a beneficial effect on confirmed disability ...

6. neurology.org neurology.org/doi/10.1212/WNL.0000000000204912

Safety of Remibrutinib Across Immune-mediated Diseases ... This integrated safety analysis confirmed the consistently favorable safety profile of remibrutinib across indications and doses, including 100 mg twice daily.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S221103482400693X

156. Safety of Remibrutinib across Immune-mediated ... This integrated safety analysis confirmed the consistently favorable safety profile of remibrutinib across indications and doses, including 100 mg twice daily.

8. msard-journal.com msard-journal.com/article/S2211-0348(23)00816-7/fulltext

Efficacy, Safety, and Tolerability of Remibrutinib in Patients ... Remibrutinib is a potent, highly selective, covalent BTK inhibitor with a promising pharmacological and safety profile. Material(s) and Method(s). REMODEL I and ...