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NCT04548999 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)
A Phase 3 study of Multiple Sclerosis, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 769
- Enrollment target
- 20
- Study locations
NCT04548999: Active Phase 3 study of Multiple Sclerosis, sponsored by Hoffmann-La Roche.
NCT04548999 is a Phase 3 study of Multiple Sclerosis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 769 participants, above the 583-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04548999, a Phase 3 study of Multiple Sclerosis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 769 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with PPMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.
Primary Outcome
Time to onset of 12-week cCDP=first occurrence of a 12-week cCDP according to at least 1 of the 3 criteria: 1) CDP=12-week confirmed increase (CI) from baseline (FB) in expanded disability status scale (EDSS) score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 12-week CI≥0.5 point in participants with baseline EDSS score of \>5.5 OR 2) 12-week CI of ≥20% FB in Timed 25-foot Walk Test (T25FWT) score OR 3)12-week CI of ≥ 20% FB in 9-hole Peg Test (9-HPT) score. EDSS = disabilit
Conditions Studied
Interventions
- DRUG Methylprednisolone
- DRUG Ocrelizumab
- DRUG Antihistamine
Study Locations (20)
California
- University of California Irvine - Irvine
- Stanford University Medical Center - Stanford
Colorado
- University of Colorado Denver - Aurora
- Advanced Neurosciences Research LLC - Fort Collins
Florida
- MS and Neuromuscular Center of Excellence - Clearwater
- University of South Florida - Tampa
Massachusetts
- Massachusetts General Hospital. - Boston
- University of Massachusetts Medical School - Worcester
New York
- Northwell Health - Great Neck
- Lenox Hill Hospital - New York
Tennessee
- Neurology Clinic PC - Cordova
- Advanced Neurosciences Institute - Nashville
Alabama
- Alabama Neurology Associates - Homewood
Arizona
- 21st Century Neurology - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 769 participants |
| Start Date | 2020-12-03 |
| Est. Completion | 2027-09-08 |
| Phase | Phase 3 |
What the registry record for NCT04548999 still lists
NCT04548999 is an interventional study that assigns participants to a tested intervention. The registered 769 participants enrollment target is mid-sized for trials with a published cap, above the 583-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (32% higher).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Methylprednisolone is the first listed.
NCT04548999 names 20 study sites across 14 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT04548999 about?
NCT04548999 is a clinical study titled "A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)". This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with PPMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.
What is the current status of trial NCT04548999?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 769 participants. The study started on 2020-12-03. Estimated completion is 2027-09-08.
What conditions does trial NCT04548999 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT04548999?
The interventions under investigation include: Methylprednisolone (DRUG), Ocrelizumab (DRUG), Antihistamine (DRUG).
Who is sponsoring clinical trial NCT04548999?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04548999 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04548999's enrollment target sits among peer trials
769 36th of 315 higher than 280 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
RECRUITING · Phase 3
-
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
RECRUITING · Phase 3
-
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
ACTIVE NOT RECRUITING · Phase 3
-
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
ACTIVE NOT RECRUITING · Phase 3
-
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
ACTIVE NOT RECRUITING · Phase 3
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