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Active, not recruiting Phase 3 Interventional

Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

ClinicalTrials.gov ID: NCT04586023

Public ClinicalTrials.gov record NCT04586023. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III Multicenter Randomized, Double-blind, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension (OLE) phase of the study.

Study identification

NCT ID
NCT04586023
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
751 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 23, 2021
Primary completion
Sep 4, 2025
Completion
Jul 8, 2027
Last update posted
Jun 22, 2026

2021 – 2027

United States locations

U.S. sites
12
U.S. states
12
U.S. cities
12
Facility City State ZIP Site status
North Central Neurology Associates Cullman Alabama 35058
Xenoscience Phoenix Arizona 85004
Los Angeles Biomedical Research Institute at Harbor-UCLA Torrance California 90502
Georgetown University Medical Center Washington D.C. District of Columbia 20007
University of South Florida Tampa Florida 33612
American Health Network Institute, LLC Avon Indiana 46123
University of Kansas Medical Center Kansas City Kansas 66160
Neuro Institute of New England P.C. Foxborough Massachusetts 02035
University of Cincinnati Cincinnati Ohio 45219
Hope Neurology Knoxville Tennessee 37922
Integrated Neurology Services PLLC Falls Church Virginia 22043
Medical College of Wisconsin, Inc. Milwaukee Wisconsin 53226-3596

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 94 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04586023, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 22, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04586023 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →