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Bruton's Tyrosine Kinase (BTK) Inhibitor
Fenebrutinib vs Teriflunomide for Multiple Sclerosis (FENhance 2 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 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights
FENhance 2 Trial Summary
This trial is testing whether a new drug, fenebrutinib, is better than the current standard of care, teriflunomide, at slowing disability progression and relapse rate in people with RMS.
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.Check my eligibility
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.See study design
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.
FENhance 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
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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.
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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.
FENhance 2 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 2 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
2,428 Previous Clinical Trials
1,088,303 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,278 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,751 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,605 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 6 weeks.My blood tests show I have low blood cell counts.I can walk 25 feet in less than 150 seconds.I have had cancer, including blood or solid tumors, in the last 10 years.I can complete a manual dexterity test in less than 4 minutes with each hand.I haven't taken hormone or steroid pills or injections in the last 4 weeks.I haven't taken any immune-altering drugs recently without a break.You have had problems with drinking too much alcohol or using drugs in the past year.You cannot undergo an MRI scan.My disability level allows me to walk without aid or rest for 200 meters.If you are a woman who can have children, you agree to not have sex or use birth control methods to avoid getting pregnant during the study. You also agree to not donate eggs.I need long-term steroids or immunosuppressants for another health issue.I have been diagnosed with RMS according to the 2017 guidelines.I do not have HIV or any condition that weakens my immune system.I do not have any major health issues that could affect the study.I agree to not have sex or use birth control and not donate sperm.My disability level is moderate or less.My condition meets the 2017 McDonald Criteria for RMS.I am pregnant, breastfeeding, or planning to become pregnant.I plan to try for a child during the study.My disease has lasted more than 10 years and I have little to no disability.My condition is either primary progressive MS or non-active secondary progressive MS.I do not have any active infections, including Hepatitis B or C, TB, or PML.I have a rare genetic issue with digesting certain sugars.I can walk 25 feet in less than 150 seconds.I have cirrhosis or Gilbert's Syndrome.I agree to not have sex or use birth control and not donate sperm.You have low levels of protein in your blood.I can complete a hand dexterity test in less than 4 minutes for each hand.
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.
Is this research project open to individuals who are below the age of 60?
"This trial, like all medical trials, has age limits for participants. The young age limit is 18 while the upper age limit is 55."
Answered by AI
How many facilities are included in this research project?
"28 different hospitals and clinics are participating in this study, with recruitment happening in Detroit, Kansas City, Stanford and 25 other locations. If you're considering enrolling, it might be best to choose a location near you in order to reduce travel."
Answered by AI
Could you please list the other instances where fenebrutinib has been studied?
"The medication fenebrutinib was first studied in 2014 at site 056001. To date, there have been 2721 completed trials with 15 more ongoing trials. Many of these active trials are located in Detroit, Michigan."
Answered by AI
Has fenebrutinib been cleared by the FDA?
"Fenebrutinib's safety is based on data from previous clinical trials and has been estimated to be a 3 on a scale from 1 to 3."
Answered by AI
Have scientists conducted similar research in the past?
"Fenebrutinib has been under clinical investigation since 2014. The first study was sponsored by Genzyme, a Sanofi Company. After the first trial, which included 166 patients, fenebrutinib received Phase 3 drug approval. Today, there are 15 active studies for fenebrutinib being conducted in 62 countries and 346 cities."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
University of Kansas Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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