Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis
NCT04544449 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Ocrelizumab
- DRUG Fenebrutinib
- DRUG Placebo matched to ocrelizumab
- DRUG Placebo matched to fenebrutinib
Study Locations (20)
California
- Sutter East Bay Medical Foundation — Berkeley
- Fullerton Neurology and Headache Center — Fullerton
- Palo Alto Medical Foundation Research Center — Sunnyvale
Florida
- Neurology Associates PA — Maitland
- Neurological Services of Orlando — Orlando
- University of South Florida — Tampa
New Jersey
- Hackensack U Med Ctr — Hackensack
- Barnabas Health Ambulatory Care Center — Livingston
Alabama
- Alabama Neurology Associates — Homewood
Colorado
- University of Colorado Denver — Aurora
Connecticut
- Yale University School Of Medicine — Fairfield
District of Columbia
- Georgetown University Medical Center — Washington D.C.
Indiana
- Josephson Wallack Munshower Neurology PC — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 985 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2027-07-21 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04544449
The ClinicalTrials.gov registry entry for NCT04544449 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 985 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Multiple Sclerosis, Primary Progressive appearing as the primary indexed condition, and to 4 interventions — of which Ocrelizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04544449 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04544449 about?
NCT04544449 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis". 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 placeb...
What is the current status of trial NCT04544449?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 985 participants. The study started on 2020-10-26. Estimated completion is 2027-07-21.
What conditions does trial NCT04544449 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Primary Progressive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04544449?
The interventions under investigation include: Ocrelizumab (DRUG), Fenebrutinib (DRUG), Placebo matched to ocrelizumab (DRUG), Placebo matched to fenebrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04544449?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04544449 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.