What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include interferon beta, glatiramer acetate, dimethyl fumarate, and alemtuzumab. Interferon beta can cause flu-like symptoms, injection site reactions, and potential liver dysfunction. Glatiramer acetate may lead to injection site reactions and transient chest pain. Dimethyl fumarate is associated with gastrointestinal issues and flushing. Alemtuzumab can increase the risk of infections and autoimmune disorders. While specific side effects of Bruton's Tyrosine Kinase inhibitors like Fenebrutinib are not detailed, they may share similar risks of infections and immune-related adverse events.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Sclerosis (MS), including disease-modifying therapies (DMTs) such as interferons, glatiramer acetate, and more recently, oral medications like fingolimod, dimethyl fumarate, and teriflunomide. While specific BTK inhibitors like fenebrutinib are still under investigation, other BTK inhibitors such as evobrutinib have shown promise in clinical trials for MS. These treatments aim to reduce the frequency of relapses and slow disease progression by targeting specific pathways involved in the immune response.

What other types of research exist?

Promising novel alternatives to Fenebrutinib for Multiple Sclerosis patients include: 1. Ocrelizumab (anti-CD20 monoclonal antibody) - effective in reducing relapse rates and slowing disability progression. 2. Siponimod (S1P receptor modulator) - shown to be effective in secondary progressive MS. 3. Cladribine (purine analog) - offers a short-course oral treatment option with sustained efficacy. 4. Ozanimod (S1P receptor modulator) - another oral option with a favorable safety profile. 5. Ublituximab (anti-CD20 monoclonal antibody) - currently in late-stage clinical trials, showing promise in reducing disease activity.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

Fenebrutinib vs Teriflunomide for Multiple Sclerosis (FENhance 2 Trial)

Q: What is the mechanism of action of this treatment?

Multiple Sclerosis (MS) treatments work by modulating the immune system to reduce inflammation and prevent damage to the nervous system. Fenebrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor, targets B cells and myeloid cells, which are involved in the autoimmune response in MS. By inhibiting BTK, Fenebrutinib reduces the activation and proliferation of these cells, thereby decreasing inflammation and neurodegeneration. Other common treatments include beta interferons and glatiramer acetate, which modulate immune responses and reduce the frequency of relapses. These mechanisms are crucial for MS patients as they help manage symptoms, reduce the progression of disability, and improve quality of life by preventing further damage to the central nervous system.

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to perform the Timed 25-Foot Walk Test (T25FWT) in <150 seconds.

Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.

Must not have

Participants with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia

History of cancer including hematologic malignancy and solid tumors within 10 years of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 12, 24, 36, 48, 60, 72, 84 and 96

Awards & highlights

Pivotal Trial

Summary

This trial is testing fenebrutinib, a medication that may help reduce disability and relapses in adults with relapsing multiple sclerosis (RMS). The study will compare fenebrutinib to another drug, teriflunomide, which is an approved treatment for RMS. Fenebrutinib works by reducing harmful immune system activity that attacks the nervous system.

Who is the study for?

Adults with Relapsing Multiple Sclerosis (RMS) who can perform specific physical tests, have an EDSS score of 0-5.5, and meet the revised 2017 McDonald Criteria for RMS diagnosis. Participants must agree to contraception if of childbearing potential and not plan to donate eggs or sperm. Exclusions include those with certain infections, a history of cancer within 10 years, severe allergies or intolerances, immunodeficiencies like HIV, recent vaccinations or steroid treatments, liver issues such as cirrhosis or Gilbert's Syndrome.

What is being tested?

The trial is testing Fenebrutinib against Teriflunomide in adults with RMS to see which is better at slowing disability progression and reducing relapse rate. Participants are randomly assigned to one of the two drugs in equal numbers. The study may extend based on positive initial results.

What are the potential side effects?

Potential side effects for both Fenebrutinib and Teriflunomide could include liver problems, hair thinning or loss (alopecia), diarrhea, nausea, fatigue, high blood pressure (hypertension), risk of infections due to immune system suppression; specific side effects will vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk 25 feet in less than 150 seconds.

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I can complete a manual dexterity test in less than 4 minutes with each hand.

Select...

My disability level allows me to walk without aid or rest for 200 meters.

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

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I agree to not have sex or use birth control and not donate sperm.

Select...

My disability level is moderate or less.

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My condition meets the 2017 McDonald Criteria for RMS.

Select...

I can walk 25 feet in less than 150 seconds.

Select...

I agree to not have sex or use birth control and not donate sperm.

Select...

I can complete a hand dexterity test in less than 4 minutes for each hand.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood tests show I have low blood cell counts.

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I have had cancer, including blood or solid tumors, in the last 10 years.

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I do not have HIV or any condition that weakens my immune system.

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I need long-term steroids or immunosuppressants for another health issue.

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I am pregnant, breastfeeding, or planning to become pregnant.

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I plan to try for a child during the study.

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My disease has lasted more than 10 years and I have little to no disability.

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My condition is either primary progressive MS or non-active secondary progressive MS.

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I do not have any active infections, including Hepatitis B or C, TB, or PML.

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I have a rare genetic issue with digesting certain sugars.

Select...

I have cirrhosis or Gilbert's Syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 12, 24, 36, 48, 60, 72, 84 and 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, weeks 12, 24, 36, 48, 60, 72, 84 and 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 12, 24, 36, 48, 60, 72, 84 and 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) Measured by the Multiple Sclerosis, 29-Item [MSIS-29] Physical Scale

Time to Onset of 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT) Score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FenebrutinibExperimental Treatment2 Interventions

Participants will receive oral fenebrutinib with teriflunomide-matching placebo.

Group II: TeriflunomideActive Control2 Interventions

Participants will receive oral teriflunomide with fenebrutinib-matching placebo in a blinded fashion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Fenebrutinib

2018

Completed Phase 3

~1750

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Sclerosis (MS) treatments work by modulating the immune system to reduce inflammation and prevent damage to the nervous system. Fenebrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor, targets B cells and myeloid cells, which are involved in the autoimmune response in MS. By inhibiting BTK, Fenebrutinib reduces the activation and proliferation of these cells, thereby decreasing inflammation and neurodegeneration. Other common treatments include beta interferons and glatiramer acetate, which modulate immune responses and reduce the frequency of relapses. These mechanisms are crucial for MS patients as they help manage symptoms, reduce the progression of disability, and improve quality of life by preventing further damage to the central nervous system.