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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8 and 12
Awards & highlights
FENopta Trial Summary
This trial will evaluate the effect of fenebrutinib on brain MRI in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated.
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.Check my eligibility
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.See study design
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.
FENopta Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My RMS diagnosis follows the 2017 McDonald Criteria.
Select...
I am a man and agree to not have unprotected sex or donate sperm.
Select...
My disability level allows me to walk without aid or rest for 200 meters.
FENopta Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 4, 8 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8 and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total Number of New Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain
Secondary outcome measures
Number of New or Enlarging T2-Weighted Lesions Observed on MRI Scans of the Brain
Percentage of Participants Free From any New Gadolinium-enhancing T1 Lesions and New or Enlarging T2-Weighted Lesions Observed on MRI Scans of the Brain
Percentage of Participants with Adverse Events (AEs)
+1 moreFENopta 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 1
~10
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,283 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,858 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,927 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
18,185 Patients Enrolled for Multiple Sclerosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My RMS diagnosis follows the 2017 McDonald Criteria.I haven't taken any corticosteroid medicines in the last 4 weeks.You are not able to have an MRI scan.I do not have any major heart, lung, kidney, liver, hormone, metabolism, or stomach conditions.I have not received a live vaccine in the last 6 weeks.I do not have any neurological disorders that could affect my MS diagnosis or study participation.I need long-term steroids or immunosuppressants for another condition.I have had cancer, including blood or solid tumors, in the last 10 years.My illness started over 10 years ago and I have little to no disability.I have a history of or currently have an immune system disorder not caused by medications, including HIV.I do not have any active infections, including Hepatitis B or C, TB, or PML.I have been diagnosed with PPMS or non-active SPMS.I recently took medication that affects my immune system without a break.I am a man and agree to not have unprotected sex or donate sperm.My disability level allows me to walk without aid or rest for 200 meters.You have had problems with drinking too much alcohol or using drugs in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Fenebrutinib
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
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