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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights
FENhance 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.Check my eligibility
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.See 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.
FENhance Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I agree to not have sex or use birth control and not donate sperm.
FENhance Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized Relapse Rate (ARR)
Secondary outcome measures
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 moreFENhance 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 1
~10
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,088,674 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,293 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
887,996 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,620 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a rare genetic issue with digesting certain sugars.My condition meets the 2017 McDonald Criteria for RMS.I can complete a manual dexterity test in less than 4 minutes with each hand.I can walk 25 feet in less than 150 seconds.I agree to not have sex or use birth control and not donate sperm.I have kidney, liver problems, or Gilbert's Syndrome.My blood tests show I have low blood cell counts.You have a recent history of alcohol or drug abuse within the past year.I finished the initial study phase without other treatments and might benefit from fenebrutinib.I haven't taken hormone or steroid pills or injections in the last 4 weeks.I am a male and plan to try for a child during the study.I have had cancer, including blood or solid tumors, in the last 10 years.My condition is primary progressive or non-active secondary progressive MS.I do not need long-term steroids or immunosuppressants.I agree to not have sex or use birth control and not donate sperm.My disability level is moderate or less.I am not pregnant, breastfeeding, nor planning to become pregnant.I will take a specific test before starting open-label fenebrutinib if I'm assigned to teriflunomide.I do not have any active infections, including Hepatitis B or C, TB, or PML.I have a history of or currently have an immune system disorder not caused by medications, including HIV.I have not received a live vaccine in the last 6 weeks.My condition started over 10 years ago and I have little to no disability.I have not taken any immune-modifying drugs recently without a break.I do not have significant heart, lung, kidney, liver, hormone, metabolism, or stomach diseases.
Research Study Groups:
This trial has the following groups:- Group 1: Teriflunomide
- Group 2: Fenebrutinib
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the fenebrutinib research landscape like?
"Fenebrutinib was first trialed in 2014 at site 056001. Since then, there have been 2720 completed clinical trials and 15 live studies. There is a significant presence of fenebrutinib trials in Kirkland, Washington."
Answered by AI
Have there been similar trials like this one before?
"Fenebrutinib has been under scientific scrutiny since 2014 when the first study, sponsored by Genzyme, was published. 166 people were a part of that initial study. Phase 3 drug approval was granted after the first clinical trial. As of now, there are 15 active studies being conducted in 346 different cities and 62 countries."
Answered by AI
Does this experimental treatment include elderly patients in its demographic?
"The age bracket that is eligible for this clinical trial starts at 18 years old and stops at 55 years old."
Answered by AI
Does fenebrutinib put patients at a heightened risk?
"Fenebrutinib's safety was given a score of 3 by our analysts at Power. This is because fenebrutinib has progressed to Phase 3 clinical trials, so there is both efficacy and safety data supporting its use."
Answered by AI
Are we still able to sign new patients up for this experiment?
"The clinical trial is recruiting patients, as indicated by the information available on clinicaltrials.gov. The trial was originally posted on 3/17/2021 and was last updated on 10/13/2022."
Answered by AI
Are there any restrictions on who is able to sign up for this research study?
"This study is investigating a potential sclerosis treatment and is currently looking for 736 participants that have the disease and are between 18-55 years old."
Answered by AI
Who else is applying?
What state do they live in?
Mississippi
California
What site did they apply to?
University of California Irvine
Other
New Orleans Center for Clinical Research
SC3 Research Group, Inc
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- SC3 Research Group, Inc: < 48 hours
Average response time
- < 2 Days
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