Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04586023 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A Phase 3 study of Relapsing Multiple Sclerosis, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 751
- Enrollment target
- 20
- Study locations
NCT04586023: Active Phase 3 study of Relapsing Multiple Sclerosis, sponsored by Hoffmann-La Roche.
NCT04586023 is a Phase 3 study of Relapsing Multiple Sclerosis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 751 participants, below the 2,137-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04586023, a Phase 3 study of Relapsing Multiple Sclerosis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 751 participants
- Enrollment target
- 20
- Study locations
Study Summary
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension (OLE) phase of the study.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Teriflunomide
- DRUG Fenebrutinib
Study Locations (20)
Rio Grande do Sul
- IMV Pesquisa Neurológica - Porto Alegre
- Núcleo de Pesquisa do Rio Grande do Sul - Porto Alegre
- Hospital Sao Lucas - PUCRS - Porto Alegre
Alabama
- North Central Neurology Associates - Cullman
Arizona
- Xenoscience - Phoenix
California
- Los Angeles Biomedical Research Institute at Harbor-UCLA - Torrance
Connecticut
- KI Health Partners, LLC - Stamford
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Florida
- University of South Florida - Tampa
Indiana
- American Health Network Institute, LLC - Avon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 751 participants |
| Start Date | 2021-03-24 |
| Est. Completion | 2027-07-09 |
| Phase | Phase 3 |
What the registry record for NCT04586023 still lists
NCT04586023 is an interventional study that assigns participants to a tested intervention. The registered 751 participants enrollment target is mid-sized for trials with a published cap, below the 2,137-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04586023 names 20 study sites across 18 states, led by Rio Grande do Sul, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT04586023 about?
NCT04586023 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)". A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after ...
What is the current status of trial NCT04586023?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 751 participants. The study started on 2021-03-24. Estimated completion is 2027-07-09.
What conditions does trial NCT04586023 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis.
What interventions are being tested in trial NCT04586023?
The interventions under investigation include: Placebo (DRUG), Teriflunomide (DRUG), Fenebrutinib (DRUG).
Who is sponsoring clinical trial NCT04586023?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04586023 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Relapsing 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 NCT04586023's enrollment target sits among peer trials
751 9th of 23 higher than 15 of 23 other Relapsing Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsing 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
-
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
RECRUITING · Phase 3
-
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
RECRUITING · Phase 3
-
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
RECRUITING · Phase 3
-
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
RECRUITING · Phase 3
-
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
ACTIVE NOT RECRUITING · Phase 3
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
- NCT06559306 · 752 participants · Phase 3
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
- NCT02048332 · 750 participants · Phase 1
Donor-Derived Viral Specific T-cells (VSTs)
- NCT02087852 · 750 participants
Kidney Cancer DNA Registry
- NCT02532452 · 750 participants · Phase 2
Third Party Viral Specific T-cells (VSTs)
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