What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis, including BTK inhibitors like Fenebrutinib, often have side effects such as infections, liver enzyme abnormalities, and gastrointestinal issues. Dimethyl fumarate can cause flushing and gastrointestinal symptoms. Glatiramer acetate may lead to injection site reactions and lipoatrophy. Interferon beta treatments are associated with flu-like symptoms, injection site reactions, and potential liver dysfunction. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Fenebrutinib is a Bruton's Tyrosine Kinase (BTK) inhibitor currently being studied for its efficacy in treating relapsing Multiple Sclerosis (RMS). While there are no specific FDA-approved BTK inhibitors for MS as of now, other classes of drugs have been approved for MS treatment. These include disease-modifying therapies (DMTs) such as interferon beta, glatiramer acetate, and more recently, monoclonal antibodies like ocrelizumab and alemtuzumab. These treatments aim to reduce the frequency of relapses and slow the progression of the disease.

What other types of research exist?

Promising novel alternatives to Fenebrutinib for Multiple Sclerosis patients include Ocrelizumab, a monoclonal antibody targeting CD20-positive B cells, and Siponimod, a selective sphingosine-1-phosphate receptor modulator. Both have shown efficacy in reducing disease activity and progression in MS. Additionally, Cladribine, an immunosuppressive drug, and Ozanimod, another sphingosine-1-phosphate receptor modulator, are also emerging as effective treatments for MS.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

Fenebrutinib for Multiple Sclerosis (FENopta Trial)

Phase 2

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

Diagnosis of RMS in accordance with the revised 2017 McDonald Criteria

Male participants must agree to remain abstinent or use contraceptive measures, and refrain from donating sperm

Must not have

Receipt of a live-attenuated vaccine within 6 weeks prior to randomization

Presence of other neurological disorders that could interfere with the diagnosis of MS or with the assessments of safety or efficacy during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ole baseline (dbt week 12) up to week 192

Summary

This trial is testing fenebrutinib, a medication, to see its effects on the brain in people with relapsing multiple sclerosis (RMS). Researchers will use MRI scans to observe any changes. They will also check if the drug is safe and how it is processed by the body. Participants will either receive fenebrutinib or a non-active substance.

Who is the study for?

This trial is for people with Relapsing Multiple Sclerosis (RMS) who meet the 2017 McDonald Criteria, have an EDSS score of 0-5.5, and agree to use birth control. It's not for those with a disease duration over 10 years and low disability, pregnant or planning pregnancy, non-active SPMS, certain infections like TB or hepatitis B/C, cancer in the last decade, recent steroid therapy or vaccines, untreated drug abuse within a year.

What is being tested?

The study tests Fenebrutinib's effects on brain MRI results in RMS patients compared to a placebo. Participants will be randomly assigned to receive either Fenebrutinib or a dummy pill without any active medication.

What are the potential side effects?

While specific side effects of Fenebrutinib are not listed here, common side effects may include issues related to immune response such as infections due to lowered immunity; liver function changes; potential allergic reactions; and possibly gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

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

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My RMS diagnosis follows the 2017 McDonald Criteria.

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I am a man and agree to not have unprotected sex or donate sperm.

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

Exclusion Criteria

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

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I have not received a live vaccine in the last 6 weeks.

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I do not have any neurological disorders that could affect my MS diagnosis or study participation.

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

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I have been diagnosed with PPMS or non-active SPMS.

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My illness started over 10 years ago and I have little to no disability.

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I have a history of or currently have an immune system disorder not caused by medications, including HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ole baseline (dbt week 12) up to week 192

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ole baseline (dbt week 12) up to week 192

This trial's timeline: 3 weeks for screening, Varies for treatment, and ole baseline (dbt week 12) up to week 192 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

DBT Phase: New Gadolinium (Gd) - Enhancing T1 Lesion Rate Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain Over 12 Weeks

Secondary study objectives

DBT Phase: New or Enlarging T2 - Weighted Lesion Rate Observed on MRI Scans of the Brain Over 12 Weeks

DBT Phase: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

DBT Phase: Proportion of Participants Free From Any New Gd - Enhancing T1 Lesions and New or Enlarging T2 - Weighted Lesions Observed on MRI Scans of the Brain Over 12 Weeks

+2 more

Other study objectives

DBT Phase: New Gd - Enhancing T1 Lesion Rate Observed on MRI Scans of the Brain at Week 12

DBT Phase: New Gd - Enhancing T1 Lesion Rate Observed on MRI Scans of the Brain at Week 4

DBT Phase: New Gd - Enhancing T1 Lesion Rate Observed on MRI Scans of the Brain at Week 8

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FenebrutinibExperimental Treatment1 Intervention

Participants will receive oral fenebrutinib.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive oral placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fenebrutinib

2018

Completed Phase 3

~1750

0 / 10Eligibility 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 further damage to the nervous system. Bruton's Tyrosine Kinase (BTK) inhibitors, such as fenebrutinib, block BTK, a key enzyme in the activation of B cells and other immune cells, thereby reducing their harmful activity. Beta interferons and glatiramer acetate modulate immune responses and reduce the frequency of relapses. Alemtuzumab targets and depletes immune cells that attack the nervous system, while dimethyl fumarate activates the Nrf2 pathway, providing anti-inflammatory and neuroprotective effects. These mechanisms are crucial for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression, improving overall quality of life.