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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 below
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My RMS diagnosis follows the 2017 McDonald Criteria.
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I am a man and agree to not have unprotected sex or donate sperm.
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My disability level allows me to walk without aid or rest for 200 meters.

FENopta Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8 and 12 for reporting.

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 more

FENopta 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
2,428 Previous Clinical Trials
1,088,945 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,920 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,393 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
18,247 Patients Enrolled for Multiple Sclerosis

Media Library

Fenebrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05119569 — Phase 2
Multiple Sclerosis Research Study Groups: Fenebrutinib, Placebo
Multiple Sclerosis Clinical Trial 2023: Fenebrutinib Highlights & Side Effects. Trial Name: NCT05119569 — Phase 2
Fenebrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05119569 — Phase 2

Frequently Asked Questions

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

How many individuals are participating in this empirical research?

"Indeed, clinicaltrials.gov shows the trial is still recruiting participants since it was first published on March 1st of 2022 and last updated in November 10th of 2022. A total of 102 patients are being accepted across two sites."

Answered by AI

Could I potentially join the cohort of this clinical study?

"This clinical trial is open to 102 individuals aged between 18 and 55 that have been diagnosed with multiple sclerosis. Furthermore, they must meet the revised McDonald Criteria for RMS as well as having a EDSS score of 0-5.5 at screening. For female patients capable of bearing children, abstinence or contraception will be mandated whilst male participants are also required to abstain from sexual intercourse or use birth control measures in addition to not donating sperm."

Answered by AI

Does the Food and Drug Administration have a stamp of approval on fenebrutinib?

"Supported by a Phase 2 trial, the safety of fenebrutinib is estimated to be moderate at a score of 2. Currently, no data exists that proves its efficacy."

Answered by AI

Is the enrollment process still ongoing for this research endeavor?

"Clinicaltrials.gov affirms that this medical investigation is actively recruiting subjects; the study was first advertised on March 1st 2022 and recently revised on November 10th 2022."

Answered by AI

Is this experiment open to seniors who are at least 70 years of age?

"This clinical trial has an age-based eligibility threshold, wherein individuals above 18 years old and below 55 can be accepted."

Answered by AI

Is this experiment a pioneering endeavor in its field?

"Fenebrutinib is the subject of 4 live clinical trials spanning 41 countries and 168 cities. The initial exploration into this medication, conducted by Hoffmann-La Roche in 2020, involved 946 participants and reached its final approval step at Phase 3. Since then, a further 2698 experiments have been carried out with fenebrutinib."

Answered by AI

Are there other investigations that have included fenebrutinib?

"At present, fenebrutinib is the focus of 4 live medical studies with 3 in their final phase. Most of these clinical trials are held in Cali and Liguria, however 522 different sites around the world have experiments running concerning this medication."

Answered by AI
~35 spots leftby Apr 2025