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NCT04586010 · ClinicalTrials.gov registry record · Phase 3
A 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
- 746
- Enrollment target
- 20
- Study locations
NCT04586010: Active Phase 3 study of Relapsing Multiple Sclerosis, sponsored by Hoffmann-La Roche.
NCT04586010 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 746 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 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04586010, 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
- 746 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 1:1 to either fenebrutinib or teriflunomide. At the end of the DBT phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension phase of the study.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Teriflunomide
- DRUG Fenebrutinib
Study Locations (20)
California
- Profound Research, LLC - Carlsbad
- University of California Irvine - Irvine
- SC3 Research Group, Inc - Pasadena
Colorado
- University of Colorado Denver - Aurora
- Mountain View Clinical Research - Denver
- Advanced Neurology of Colorado, LLC - Fort Collins
Alabama
- University of Alabama Birmingham - Birmingham
- Alabama Neurology Associates - Homewood
Louisiana
- The NeuroMedical Center - Baton Rouge
- Ochsner LSU Health - Shreveport
Arizona
- Center for Neurology and Spine - Phoenix - Hunt - PPDS - Phoenix
Florida
- Neurology Associates, PA; Research Department - Maitland
Illinois
- NorthShore University HealthSystem - Highland Park
Indiana
- Fort Wayne Neurological Center - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 746 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 3 |
What the registry record for NCT04586010 still lists
NCT04586010 is an interventional study that assigns participants to a tested intervention. The registered 746 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.
NCT04586010 names 20 study sites across 14 states, led by California, Colorado, Alabama.
Frequently Asked Questions
What is clinical trial NCT04586010 about?
NCT04586010 is a clinical study titled "A 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 1:1 to either fenebrutinib or teriflunomide. At the end of the DBT phase (after disclosure of the DBT results), the Sponsor ...
What is the current status of trial NCT04586010?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 746 participants. The study started on 2021-03-17. Estimated completion is 2027-11-30.
What conditions does trial NCT04586010 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis.
What interventions are being tested in trial NCT04586010?
The interventions under investigation include: Placebo (DRUG), Teriflunomide (DRUG), Fenebrutinib (DRUG).
Who is sponsoring clinical trial NCT04586010?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04586010 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 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 NCT04586010's enrollment target sits among peer trials
746 10th of 23 higher than 14 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.
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