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NCT04544449 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis
A Phase 3 study of Multiple Sclerosis, Primary Progressive, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 985
- Enrollment target
- 20
- Study locations
NCT04544449 is a Phase 3 study of Multiple Sclerosis, Primary Progressive that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 985 participants, above the 346-participant average among 7 other Multiple Sclerosis, Primary Progressive trials with a reported enrollment target (185% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT04544449, a Phase 3 study of Multiple Sclerosis, Primary Progressive, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 985 participants
- Enrollment target
- 20
- Study locations
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?
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, categorized as Phase 3. The registered enrollment target is 985 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 346-participant average among 7 other Multiple Sclerosis, Primary Progressive trials with a reported enrollment target (185% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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.
NCT04544449 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, New Jersey.
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.
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).
Who is sponsoring clinical trial NCT04544449?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.