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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 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.

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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

Relapsing Multiple Sclerosis

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

FieldValue
Enrollment Target 751 participants
Start Date 2021-03-24
Est. Completion 2027-07-09
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04586023

The ClinicalTrials.gov registry entry for NCT04586023 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 751 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,137-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (65% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 18 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.