A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis
Public ClinicalTrials.gov record NCT04544449. 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 Ocrelizumab in Adult Patients With Primary Progressive 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 in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). 985 participants were enrolled and recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Study identification
- NCT ID
- NCT04544449
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 985 participants
Conditions and interventions
Conditions
Interventions
- Fenebrutinib Drug
- Ocrelizumab Drug
- Placebo matched to ocrelizumab Drug
- Placebo matched to fenebrutinib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 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
- Oct 26, 2020 (Actual)
- Primary completion
- Sep 17, 2025 (Actual)
- Completion
- Jul 21, 2027 (Estimated)
- Last update posted
- Sep 17, 2026
2020 – 2027
United States locations
- U.S. sites
- 43
- U.S. states
- 24
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Neurology Associates | Homewood | Alabama | 35209 | — |
| Sutter East Bay Medical Foundation | Berkeley | California | 94705 | — |
| Fullerton Neurology and Headache Center | Fullerton | California | 92835 | — |
| Palo Alto Medical Foundation Research Center | Sunnyvale | California | 94086 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Yale University School Of Medicine | Fairfield | Connecticut | 06824 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Neurology Associates PA | Maitland | Florida | 32751 | — |
| Neurological Services of Orlando | Orlando | Florida | 32806 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Josephson Wallack Munshower Neurology PC | Indianapolis | Indiana | 46256 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Johns Hopkins University School Of Medicine | Baltimore | Maryland | 21287 | — |
| Dragonfly Research, LLC | Wellesley | Massachusetts | 02481 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Minneapolis Clinic of Neurology | Golden Valley | Minnesota | 55422 | — |
| Washington University | St Louis | Missouri | 63128 | — |
| Cleveland Clinic Lou Ruvo | Las Vegas | Nevada | 89106 | — |
| Hackensack U Med Ctr | Hackensack | New Jersey | 07601 | — |
| Barnabas Health Ambulatory Care Center | Livingston | New Jersey | 07039 | — |
| Jersey Shore University Medical Centre | Neptune City | New Jersey | 07753 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | — |
| Holy Name Hospital | Teaneck | New Jersey | 07666 | — |
| Dent Neurological Institute | Amherst | New York | 14226 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Atrium Health Neurosciences Institute ? Charlotte | Charlotte | North Carolina | 28204 | — |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607-6520 | — |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | — |
| UC Health, LLC. | Cincinnati | Ohio | 45267 | — |
| OhioHealth Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Providence Brain and Spine Institute | Portland | Oregon | 97225 | — |
| Neurology Clinic PC | Cordova | Tennessee | 38018 | — |
| Hope Neurology | Knoxville | Tennessee | 37922 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Uni of Texas Health Science Center At Houston | Houston | Texas | 77030 | — |
| Texas Institute for Neurological Disorders | Sherman | Texas | 75092 | — |
| Evergreen MS Center | Kirkland | Washington | 98034 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| 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 147 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04544449, 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 17, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04544449 live on ClinicalTrials.gov.