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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT04586010

Public ClinicalTrials.gov record NCT04586010. 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 Oct 18, 2026, 8:58 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
NCT04586010
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
746 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 17, 2021 (Actual)
Primary completion
Jan 27, 2026 (Actual)
Completion
Nov 30, 2027 (Estimated)
Last update posted
Sep 21, 2026

2021 – 2027

United States locations

U.S. sites
32
U.S. states
23
U.S. cities
31
Facility City State ZIP Site status
University of Alabama Birmingham Birmingham Alabama 35233 —
Alabama Neurology Associates Homewood Alabama 35209 —
Center for Neurology and Spine - Phoenix - Hunt - PPDS Phoenix Arizona 85032 —
Profound Research, LLC Carlsbad California 92011 —
University of California Irvine Irvine California 92697 —
Quantum Clinical Research, Inc Pasadena California 91106 —
University of Colorado Denver Aurora Colorado 80045 —
Mountain View Clinical Research Denver Colorado 80209 —
Advanced Neurology of Colorado, LLC Fort Collins Colorado 80528 —
Neurology Associates, PA; Research Department Maitland Florida 32751 —
NorthShore University HealthSystem Highland Park Illinois 60035 —
Fort Wayne Neurological Center Fort Wayne Indiana 46805 —
The NeuroMedical Center Baton Rouge Louisiana 70810 —
Ochsner LSU Health Shreveport Louisiana 71103 —
Johns Hopkins University School Of Medicine; Outpatient Center Baltimore Maryland 21287 —
University of Massachusetts Medical School Worcester Massachusetts 01655 —
Henry Ford Health System Detroit Michigan 48202 —
Washington University School of Medicine St Louis Missouri 63110 —
Holy Name Hospital; Institute For Clinical Research Teaneck New Jersey 07666 —
University of New Mexico; MS Specialty Clinic Albuquerque New Mexico 87131 —
Miami Valley Hospital South; Dayton Physician's Office Centerville Ohio 45459 —
OhioHealth Columbus Ohio 43214 —
The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company Columbus Ohio 43235 —
Oklahoma Medical Research Foundation; MS Center of Excellence Oklahoma City Oklahoma 73104 —
St. Luke's University Health network Bethlehem Pennsylvania 18015 —
Premier Neurology Greenville South Carolina 29605 —
New Orleans Center for Clinical Research Knoxville Tennessee 37920 —
North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic Plano Texas 75024 —
Texas Institute for Neurological Disorders Sherman Texas 75092 —
Multiple Sclerosis Center of Greater Washington Vienna Virginia 22182 —
Evergreen MS Center Kirkland Washington 98034 —
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders Milwaukee Wisconsin 53215 —

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 126 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04586010, 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 Sep 21, 2026 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04586010 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →