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NCT05119569 · ClinicalTrials.gov registry record · Phase 2

A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

A Phase 2 study of Relapsing Multiple Sclerosis, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 2
Development phase
109
Enrollment target
17
Study locations

NCT05119569 is a Phase 2 study of Relapsing Multiple Sclerosis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 109 participants, below the 2,165-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (95% lower). The trial reports 17 study locations across 3 states.

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The verdict

NCT05119569, a Phase 2 study of Relapsing Multiple Sclerosis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
109 participants
Enrollment target
17
Study locations

Study Summary

This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo. This study consists of two parts: Double-blind treatment (DBT) phase and an optional Open-label extension (OLE) phase.

Conditions Studied

Relapsing Multiple Sclerosis

Interventions

  • DRUG Placebo
  • DRUG Fenebrutinib

Study Locations (17)

Other

  • University Clinical Centre of the Republic of Srpska - Banja Luka
  • Clinical Hospital Center Rijeka - PPDS - Rijeka
  • General Hospital Varazdin - Varaždin
  • Klinicki bolnicki centar Zagreb - Zagreb
  • Poliklinika Solmed - Zagreb
  • Fakultni nemocnice u sv. Anny v Brne - Brno
  • Fakultni nemocnice Hradec Kralove - Hradec Králové
  • Nemocnice Jihlava - Jihlava
  • Vseobecna Fakultni Nemocnice V Praze - CRC - PPDS - Prague
  • Clinical Center of Serbia - Belgrade
  • Military Medical Academy - Belgrade
  • Clinical center Kragujevac - Kragujevac
  • Clinical Center Nis - Niš
  • Clinical Hospital Centre Zemun - Zemun
  • Univerzitna nemocnica Bratislava - Bratislava

California

  • Fullerton Neurology and Headache Center - Fullerton

Nevada

  • Cleveland Clinic Lou Ruvo - Las Vegas

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2022-03-01
Est. Completion 2026-12-30
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05119569

The ClinicalTrials.gov registry entry for NCT05119569 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,165-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (95% 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 2 interventions - of which Placebo is the first listed.

NCT05119569 reports 17 study locations spanning 3 distinct geographic areas - top geographies include Other, California, Nevada.

Frequently Asked Questions

What is clinical trial NCT05119569 about?

NCT05119569 is a clinical study titled "A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)". This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo. This study consists of two part...

What is the current status of trial NCT05119569?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2022-03-01. Estimated completion is 2026-12-30.

What conditions does trial NCT05119569 study?

This clinical trial studies the following conditions: Relapsing Multiple Sclerosis.

What interventions are being tested in trial NCT05119569?

The interventions under investigation include: Placebo (DRUG), Fenebrutinib (DRUG).

Who is sponsoring clinical trial NCT05119569?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05119569 being conducted?

This trial has 17 study locations across California, Nevada. 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.