Fenebrutinib for Multiple Sclerosis
(FENopta Trial)

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Hoffmann-La Roche

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing fenebrutinib, a medication, to see its effects on the brain in people with relapsing multiple sclerosis (RMS). Researchers will use MRI scans to observe any changes. They will also check if the drug is safe and how it is processed by the body. Participants will either receive fenebrutinib or a non-active substance.

Eligibility Criteria

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.

Inclusion Criteria

My RMS diagnosis follows the 2017 McDonald Criteria.

Female participants of childbearing potential must agree to remain abstinent or use contraceptive measures, and refrain from donating eggs

I am a man and agree to not have unprotected sex or donate sperm.

+1 more

Exclusion 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.

+12 more

Participant Groups

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.

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.