Remibrutinib for Multiple Sclerosis

(REMASTER Trial)

Recruiting at 11 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Disqualifiers: CNS disease, Substance abuse, PML, others

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

1275 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 secondary progressive multiple sclerosis (SPMS), a form of MS where symptoms gradually worsen over time. The goal is to determine if remibrutinib is safe and effective in slowing the progression of this condition. Participants will receive either remibrutinib or a placebo (a pill with no active medicine) to compare results. Those with SPMS who haven't had relapses in the past two years and have noticed worsening disability in the last year might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications, but it mentions that certain medications may be excluded. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that remibrutinib is likely to be safe for humans?

Previous studies have consistently shown that remibrutinib has a good safety record. Research on remibrutinib for various conditions and doses, including 100 mg taken twice daily, found it generally well-tolerated by patients. This indicates that people taking remibrutinib did not experience serious side effects that would lead them to stop treatment. While minor side effects can occur, the safety data suggests that remibrutinib is safe for humans, making it a promising option for treating conditions like multiple sclerosis. ^{1 2 3 4 5}

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

Remibrutinib is unique because it works by targeting Bruton’s tyrosine kinase (BTK), which plays a crucial role in the immune system's signaling processes. Unlike traditional treatments for multiple sclerosis, such as interferons or monoclonal antibodies, which broadly suppress immune activity, Remibrutinib specifically inhibits BTK to reduce inflammation more precisely. This targeted approach may lead to fewer side effects and improve patients' quality of life, which is why researchers are eager to see its potential benefits.

What evidence suggests that remibrutinib might be an effective treatment for multiple sclerosis?

Research has shown that remibrutinib may help treat multiple sclerosis (MS) by reducing swelling in the nervous system caused by certain immune cells. Studies have found remibrutinib effective in early tests for MS. In this trial, participants will receive either remibrutinib or a placebo. In trials for relapsing MS, researchers compared remibrutinib to another drug, teriflunomide, and it showed positive results. Additionally, remibrutinib has demonstrated safety, which is promising for its use in autoimmune diseases like MS. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with secondary progressive multiple sclerosis (SPMS) who haven't had clinical relapses in the last 24 months. Participants must have an EDSS score of 3.0 to 6.0 and show disability progression in the past year.

Inclusion Criteria

I have signed the consent form for this trial.

I haven't had any worsening of my condition in the last 2 years.

My disability level is moderate, as measured by the EDSS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Part

Participants receive double-blind treatment with either remibrutinib or placebo

Up to approximately 5 years

Extension Part

Participants receive open-label remibrutinib treatment

Up to approximately 5 years

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 tests Remibrutinib's effectiveness and safety for SPMS patients, comparing it against a placebo. Some participants will know they're getting Remibrutinib (open label), while others won't know if they are receiving the drug or a placebo (blinded).

How Is the Trial Designed?

Group I: Remibrutinib (LOU064) Experimental Treatment 2 Interventions

Core Part: Remibrutinib film-coated tablet taken orally \[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]

Group II: Placebo Placebo Group 2 Interventions

Core Part: Matching placebo film-coated tablet taken orally \[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]

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/NCT07222956

A Study of Remibrutinib Using MR Imaging in Relapsing or ...

The study is an investigator-run, study following participants for 2 years with twice-daily remibrutinib. MRI is the main endpoint.

2.

novartis.com

novartis.com/clinicaltrials/study/nct07225504

A Study to Evaluate the Efficacy and Safety of Remibrutinib ...

The purpose of this study is to provide efficacy and safety data for remibrutinib. EDSS score of 3.0 to 6.0 (inclusive) at Screening.

3.

pmc.ncbi.nlm.nih.gov

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

Remibrutinib (LOU064) inhibits neuroinflammation driven by B ...

Remibrutinib (LOU064) inhibits neuroinflammation driven by B cells and myeloid cells in preclinical models of multiple sclerosis. Remibrutinib ...

4.

neurology.org

neurology.org/doi/10.1212/WNL.98.18_supplement.2562

Phase 3 REMODEL I/II Trials: Remibrutinib for Relapsing MS

The REMODEL I and II Phase 3 trials aimed to evaluate the efficacy, safety and tolerability of remibrutinib versus teriflunomide in patients with relapsing ...

5.

neurologylive.com

neurologylive.com/view/new-phase-3-study-evaluate-remibrutinib-generalized-myasthenia-gravis-treatment

New Phase 3 Study to Evaluate Remibrutinib in ...

Remibrutinib has demonstrated a positive safety profile in previous studies for autoimmune disorders, supporting its investigation in multiple ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05147220

NCT05147220 | Efficacy and Safety of Remibrutinib ...

Study Overview. Brief Summary. To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS).

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 ...

The REMODEL I and II studies will investigate the efficacy, safety, and tolerability of remibrutinib versus teriflunomide to support regulatory approval ...