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Bruton's Tyrosine Kinase (BTK) Inhibitor

Fenebrutinib for Relapsing Multiple Sclerosis (FENhance Trial)

Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
Must not have
Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0.
Female participants who are pregnant or breastfeeding, or intending to become pregnant.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights
Pivotal Trial

Summary

This trial will test whether fenebrutinib can help treat relapsing MS by reducing disability progression and relapse rate, compared to teriflunomide. If the results are positive, participants will have the option to continue taking fenebrutinib in an extension phase.

Who is the study for?
Adults with Relapsing Multiple Sclerosis (RMS) who meet specific criteria like an EDSS score of 0-5.5, can complete certain physical tests within set times, and agree to use contraception or abstain from sex. Excluded are those with disease duration over 10 years and low disability, pregnant or breastfeeding women, individuals with recent cancer history, active infections including hepatitis B/C and TB, significant blood disorders or immunodeficiency.
What is being tested?
The trial is testing the effectiveness of Fenebrutinib compared to Teriflunomide in managing RMS by looking at disability progression and relapse rate. Participants will be randomly assigned to either drug in a direct comparison study design.
What are the potential side effects?
Potential side effects for both Fenebrutinib and Teriflunomide may include liver problems, hair thinning or loss, diarrhea, nausea, risk of infections due to immune system suppression; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disability level is moderate or less.
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My condition meets the 2017 McDonald Criteria for RMS.
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I can complete a manual dexterity test in less than 4 minutes with each hand.
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I can walk 25 feet in less than 150 seconds.
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I agree to not have sex or use birth control and not donate sperm.
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I agree to not have sex or use birth control and not donate sperm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition started over 10 years ago and I have little to no disability.
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I am not pregnant, breastfeeding, nor planning to become pregnant.
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I am a male and plan to try for a child during the study.
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My condition is primary progressive 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 had cancer, including blood or solid tumors, in the last 10 years.
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I do not have significant heart, lung, kidney, liver, hormone, metabolism, or stomach diseases.
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I have a rare genetic issue with digesting certain sugars.
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My blood tests show I have low blood cell counts.
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I do not need long-term steroids or immunosuppressants.
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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 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized Relapse Rate (ARR)
Secondary study objectives
Change from Baseline to Week 48 in the Concentration of Serum Neurofilament Light Chain (NfL)
Change in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) Measured by the Multiple Sclerosis, 29-Item [MSIS-29] Physical Scale
Percentage Change in Total Brain Volume from Week 24 as Assessed by MRI
+8 more

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
Fenebrutinib
2018
Completed Phase 3
~1750
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,457 Previous Clinical Trials
1,096,976 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
24,784 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,227 Previous Clinical Trials
895,666 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
18,110 Patients Enrolled for Multiple Sclerosis

Media Library

Fenebrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04586010 — Phase 3
Multiple Sclerosis Research Study Groups: Teriflunomide, Fenebrutinib
Multiple Sclerosis Clinical Trial 2023: Fenebrutinib Highlights & Side Effects. Trial Name: NCT04586010 — Phase 3
Fenebrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04586010 — Phase 3
~136 spots leftby Oct 2025
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