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Bruton's Tyrosine Kinase (BTK) Inhibitor

Fenebrutinib vs Ocrelizumab for Multiple Sclerosis (FENtrepid Trial)

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 Timed 25-Foot Walk Test (T25FWT) in <150 seconds
Expanded Disability Status Scale (EDSS) score from 3.0 to 6.5 inclusive at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.7 years
Awards & highlights

FENtrepid Trial Summary

This trial will evaluate if fenebrutinib can help slow down disability progression in adults with PPMS, compared to placebo or to the standard of care drug ocrelizumab.

Who is the study for?
Adults with Primary Progressive Multiple Sclerosis (PPMS) who've had disability progression in the past year, can perform certain physical tests within specified times, and are neurologically stable. Women must agree to avoid pregnancy; men must prevent fathering children. Excludes those with severe liver disease, recent drug abuse, certain MS treatments without a washout period, serious reactions to ocrelizumab, immunodeficiency states or other major health issues.Check my eligibility
What is being tested?
The trial is testing fenebrutinib's effect on PPMS disability progression against ocrelizumab. Participants will be randomly assigned to take either oral fenebrutinib plus placebo or IV ocrelizumab plus placebo. The study aims for about 946 global participants and includes an Open-Label Extension phase based on positive initial results.See study design
What are the potential side effects?
Potential side effects may include allergic reactions related to infusion processes, organ inflammation due to immune response alterations by the drugs being tested, fatigue from treatment regimens, digestive disturbances as common medication-related events and increased risk of infections.

FENtrepid Trial 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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My disability level is moderate to severe but I can still walk.
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I can complete a hand dexterity test in less than 4 minutes.
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My condition is diagnosed as PPMS according to the 2017 criteria.
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I agree to not have sex or use birth control and not donate sperm.
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My disability has worsened in the last year.

FENtrepid Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12)
Secondary outcome measures
Change from Baseline in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) Measured by the Multiple Sclerosis Impact Scale, 29-Item [MSIS-29] Physical Scale
Percent Change from Screening in Serum Neurofilament Light Chain (NfL) Levels
Percentage Change in Total Brain Volume Assessed by Magnetic Resonance Imaging (MRI)
+6 more

FENtrepid Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FenebrutinibExperimental Treatment2 Interventions
Participants will receive oral fenebrutinib and intravenous (IV) ocrelizumab-matching placebo.
Group II: OcrelizumabActive Control2 Interventions
Participants will receive intravenous (IV) ocrelizumab and oral fenebrutinib-matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenebrutinib
2018
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,088,147 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,044 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
887,575 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,371 Patients Enrolled for Multiple Sclerosis

Media Library

Fenebrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04544449 — Phase 3
Multiple Sclerosis Research Study Groups: Fenebrutinib, Ocrelizumab
Multiple Sclerosis Clinical Trial 2023: Fenebrutinib Highlights & Side Effects. Trial Name: NCT04544449 — Phase 3
Fenebrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04544449 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to enroll new participants in this research project?

"Yes, this information is accurate according to the clinicaltrials.gov website. The study was first posted on October 26th, 2020 and was last edited October 27th, 2020."

Answered by AI

Who meets the requirements to join this clinical trial?

"Eligible patients for this particular study must have primary progressive multiple sclerosis and should be between 18-65 years old. The researchers conducting the trial are looking to enroll around 946 individuals."

Answered by AI

Are there any participating hospitals in North America for this clinical trial?

"This trial has many available locations, some of which include St. Michael's Hospital; MS Clinic in Toronto, Alabama Neurology Associates in Homewood, and University of Rochester in Rochester. In total, there are 49 sites where this trial is offered."

Answered by AI

Are there any antecedent studies to fenebrutinib?

"Fenebrutinib was first researched in 2008 at CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge. 2705 studies have been completed thus far, with 32 ongoing trials. A fair number of these active studies are based in Toronto, Ontario."

Answered by AI

For this particular experiment, are elderly individuals being recruited as participants?

"This study is enrolling participants who are of legal age and younger than 65 years old."

Answered by AI

What are the possible harmful side effects of fenebrutinib?

"Fenebrutinib's safety is well-documented, as this drug has reached Phase 3 clinical trials. This gives it a score of three on our Power team's scale."

Answered by AI

Have these treatments been tested before in humans?

"Fenebrutinib has been under investigation for over a decade with the first clinical trial starting in 2008. This initial study, which had 220 participants, was conducted by Genentech, Inc.. After this Phase 2 drug approval occurred in 2008, there are now 32 active trials being conducted across 337 cities and 65 countries."

Answered by AI

How many people fit the screening criteria for this research project?

"946 individuals that meet the clinical study's entrance requirements are needed to complete the trial. The sponsor, Hoffmann-La Roche, will be managing the research from multiple locations including St. Michael's Hospital; MS Clinic in Toronto, Ontario and Alabama Neurology Associates in Homewood, Alabama."

Answered by AI
~334 spots leftby Jan 2026