Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Multiple Sclerosis, Primary Progressive, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT04544449 still lists
NCT04544449 is an interventional study that assigns participants to a tested intervention. The registered 985 participants enrollment target is mid-sized for trials with a published cap, above the 346-participant average among 7 other Multiple Sclerosis, Primary Progressive trials with a reported enrollment target (185% higher).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis, Primary Progressive
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.
-
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis
RECRUITING · Phase 1
-
MS-ResearchBiomarkerS
RECRUITING
-
Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
RECRUITING · Phase 1
-
Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis
ACTIVE NOT RECRUITING · Phase 2
-
KYSA-7: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05079841 · 988 participants · Phase 4
The Stimulation To Induce Mothers Study
- NCT06989437 · 982 participants · Phase 2
A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue
- NCT06959095 · 981 participants · Phase 3
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
- NCT05441709 · 990 participants · NA
Furthering Equity Through Infant Feeding EDucation and Support
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI