A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Condition(s) studied
Investigational drug(s) / intervention(s)
Fenebrutinib: Participants will receive fenebrutinib.
Teriflunomide: Participants will receive teriflunomide.
Placebo: Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Annualized Relapse Rate (ARR) — Minimum of 96 weeks
Trial sites (158)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | |
| Alabama Neurology Associates | Homewood | Alabama | |
| Center for Neurology and Spine - Phoenix - Hunt - PPDS | Phoenix | Arizona | |
| Profound Research, LLC | Carlsbad | California | |
| University of California Irvine | Irvine | California | |
| Quantum Clinical Research, Inc | Pasadena | California | |
| University of Colorado Denver | Aurora | Colorado | |
| Mountain View Clinical Research | Denver | Colorado | |
| Advanced Neurology of Colorado, LLC | Fort Collins | Colorado | |
| Neurology Associates, PA; Research Department | Maitland | Florida | |
| NorthShore University HealthSystem | Highland Park | Illinois | |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | |
| The NeuroMedical Center | Baton Rouge | Louisiana | |
| Ochsner LSU Health | Shreveport | Louisiana | |
| Johns Hopkins University School Of Medicine; Outpatient Center | Baltimore | Maryland | |
| University of Massachusetts Medical School | Worcester | Massachusetts | |
| Henry Ford Health System | Detroit | Michigan | |
| Washington University School of Medicine | St Louis | Missouri | |
| Holy Name Hospital; Institute For Clinical Research | Teaneck | New Jersey | |
| University of New Mexico; MS Specialty Clinic | Albuquerque | New Mexico | |
| Miami Valley Hospital South; Dayton Physician's Office | Centerville | Ohio | |
| OhioHealth | Columbus | Ohio | |
| The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company | Columbus | Ohio | |
| Oklahoma Medical Research Foundation; MS Center of Excellence | Oklahoma City | Oklahoma | |
| St. Luke's University Health network | Bethlehem | Pennsylvania | |
| Premier Neurology | Greenville | South Carolina | |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | |
| North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic | Plano | Texas | |
| Texas Institute for Neurological Disorders | Sherman | Texas | |
| Multiple Sclerosis Center of Greater Washington | Vienna | Virginia | |
| Evergreen MS Center | Kirkland | Washington | |
| Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders | Milwaukee | Wisconsin | |
| Neurologia Infantil Buenos Aires (NIBA) | Buenos Aires | Argentina | |
| IME - Instituto Médico Especializado | Buenos Aires | Argentina | |
| Centro de Especialidades Neurológicas y Rehabilitación - CENyR | Buenos Aires | Argentina | |
| CIER | C. A. B. A. | Argentina | |
| Diagnostico Medico Oroño | Rosario | Argentina | |
| Cer San Juan | San Juan | Argentina | |
| Centro de Investigaciones Médicas Tucuman | San Miguel de Tucumán | Argentina | |
| Peking University First Hospital | Beijing | China |
+ 118 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04586010 on ClinicalTrials.gov ↗ ← All trials in Spain