A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
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.
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
- Enrollment
- 746 participants
Conditions and interventions
Conditions
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 16, 2021
- Primary completion
- Jan 26, 2026
- Completion
- Nov 29, 2027
- Last update posted
- May 18, 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 128 non-U.S. sites.
Recently updated Relapsing Multiple Sclerosis trials
Other public records listing Relapsing Multiple Sclerosis. Sorted by last update posted; newest first. Not a recommendation.
- NCT04586023: Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) Active, not recruiting
- NCT06847724: Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis Active, not recruiting
- NCT05147220: Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) Active, not recruiting
- NCT06846281: Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. Recruiting
- NCT05119569: A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS) Active, not recruiting
- NCT06433752: A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS) Recruiting
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 May 18, 2026 · Synced Jul 31, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04586010 live on ClinicalTrials.gov.