A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

Part of paid clinical trials in Fullerton, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05119569
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Relapsing Multiple Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Fenebrutinib — DRUG
    Fenebrutinib will be administered orally.
  • Placebo — DRUG
    Placebo will be administered orally.

Study Details

This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo. This study consists of two parts: Double-blind treatment (DBT) phase and an optional Open-label extension (OLE) phase.

Key Dates

First listed
Nov 15, 2021
Start date
Mar 1, 2022
Status verified
Aug 2026
Primary completion
Mar 29, 2023
Completion
Jun 30, 2027

Study Design

Enrollment
109 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fenebrutinib
    Participants will receive oral fenebrutinib.
  • Placebo Comparator: Placebo
    Participants will receive oral placebo.

Primary Outcome Measure

DBT Phase: New Gadolinium (Gd) - Enhancing T1 Lesion Rate Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain Over 12 Weeks [ Time Frame: MRI scans performed at Weeks 4, 8 and 12 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Fullerton Neurology and Headache CenterFullertonCalifornia92835-
Cleveland Clinic Lou RuvoLas VegasNevada89106-

Find similar trials in Fullerton, CA

By research site
Fullerton Neurology and Headache Center· Fullerton, CACleveland Clinic Lou Ruvo· Las Vegas, NV

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