A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis

New trial tests remibrutinib for secondary progressive MS

NCT: NCT07225504 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Novartis Pharmaceuticals · Started: 2025-11-11 · Est. Completion: 2034-01-02

Plain English Summary

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis is a Phase 3 clinical trial sponsored by Novartis Pharmaceuticals studying Secondary Progressive Multiple Sclerosis (SPMS). This trial tests remibrutinib, an oral medication, against a placebo to see if it can slow down disability progression in people with a specific type of multiple sclerosis. It is for adults aged 18-65 diagnosed with secondary progressive multiple sclerosis (SPMS) who have shown signs of worsening disability. Participants will take either remibrutinib or a placebo pill for up to 5 years, with regular check-ups and MRI scans. Current treatments for SPMS focus on managing symptoms or reducing relapses; this trial aims to directly address disability progression. The trial aims to enroll 1275 participants.

Official Summary

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 65 years old and have been diagnosed with SPMS. You must have experienced worsening disability in the past year and not had relapses in the last two years. You cannot join if you have other significant neurological conditions, are pregnant or planning to become pregnant, or have contraindications for MRI scans. This trial is studying Secondary Progressive Multiple Sclerosis (SPMS), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if remibrutinib can delay the confirmed worsening of disability, meaning it aims to help patients maintain their current level of function for longer. The specific primary outcome measures are: Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS) (From baseline up to approximately 5 years). 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 is important because it investigates a new treatment that could potentially slow the worsening of disability in patients with secondary progressive multiple sclerosis, a form of MS with lim 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 Secondary Progressive Multiple Sclerosis (SPMS), where improved treatment options are needed.

Investor Insight

This Phase III trial for remibrutinib, sponsored by Novartis, targets the significant unmet need in SPMS, suggesting a potentially large market if successful, with a clear path to approval if efficacy Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1275 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if remibrutinib is a suitable option for you and what the potential benefits and risks are. Participation involves taking a daily pill (either remibrutinib or placebo) and attending regular study visits for check-ups, neurological exams, and MRI scans over several years. Be prepared for potential side effects and the need for consistent adherence to the study schedule. 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

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Signed informed consent must be obtained prior to any assessment performed.
* Male or female participants aged 18-65 (inclusive) at Screening.
* Diagnosis of SPMS according to the 2017 revised McDonald criteria (Thompson et al 2018) at Screening.
* Absence of documented clinical relapses in the 24 months before Screening and randomization.
* EDSS score of 3.0 to 6.0 (inclusive) at Screening.
* Documented evidence of disability progression in the 12 months before Screening.

Exclusion Criteria:

* Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).
* History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).
* Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.
* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.
* Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.
* Significant bleeding risk or coagulation disorders, at Screening.
* Use of exclusionary medication prior to Screening/randomization as listed in the protocol.

Other protocol-defined inclusion/exclusion critria may apply

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07225504?

NCT07225504 is a Phase 3 INTERVENTIONAL study titled "A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis." It is currently recruiting and is sponsored by Novartis Pharmaceuticals. The trial targets enrollment of 1275 participants.

What conditions does NCT07225504 study?

This trial investigates treatments for Secondary Progressive Multiple Sclerosis (SPMS). The primary condition under study is Secondary Progressive Multiple Sclerosis (SPMS).

What treatments are being tested in NCT07225504?

The interventions being studied include: Remibrutinib (blinded) (DRUG), Placebo (DRUG), Remibrutinib (Open label) (DRUG). Remibrutinib (Blinded) active treatment, oral tablet

What does Phase 3 mean for NCT07225504?

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 NCT07225504?

This trial is currently "Recruiting." It started on 2025-11-11. The estimated completion date is 2034-01-02.

Who is sponsoring NCT07225504?

NCT07225504 is sponsored by Novartis Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07225504?

The trial aims to enroll 1275 participants. The trial is currently recruiting and accepting new participants.

How is NCT07225504 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT07225504?

The primary outcome measures are: Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS) (From baseline up to approximately 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07225504 being conducted?

This trial is being conducted at 20 sites, including Birmingham, Alabama; Phoenix, Arizona; Tucson, Arizona; Fullerton, California and 16 more sites (United States, Argentina).

Where can I find official information about NCT07225504?

The official record for NCT07225504 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07225504. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07225504 testing in simple terms?

This trial tests remibrutinib, an oral medication, against a placebo to see if it can slow down disability progression in people with a specific type of multiple sclerosis. It is for adults aged 18-65 diagnosed with secondary progressive multiple sclerosis (SPMS) who have shown signs of worsening disability.

Why is this trial significant?

This trial is important because it investigates a new treatment that could potentially slow the worsening of disability in patients with secondary progressive multiple sclerosis, a form of MS with lim 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 NCT07225504?

Common side effects may include headache, nausea, and fatigue. More serious risks, though rare, could involve liver problems or a higher risk of infections. The study medication is given blindly, meaning neither you nor your doctor will know if you are receiving the active drug or a placebo. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07225504?

Ask your doctor if remibrutinib is a suitable option for you and what the potential benefits and risks are. Participation involves taking a daily pill (either remibrutinib or placebo) and attending regular study visits for check-ups, neurological exams, and MRI scans over several years. Be prepared for potential side effects and the need for consistent adherence to the study schedule. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07225504 signal from an investment perspective?

This Phase III trial for remibrutinib, sponsored by Novartis, targets the significant unmet need in SPMS, suggesting a potentially large market if successful, with a clear path to approval if efficacy 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?

Participants will take either remibrutinib or a placebo pill for up to 5 years, with regular check-ups and MRI scans. 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.

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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.