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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: Active Phase 2 study of Relapsing Multiple Sclerosis, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Radiologic evaluation for Gd enhancing T1 lesion rate was performed using a standardized MRI protocol at screening, and at Weeks 4, 8, and 12. All MRI scans were read by a centralized reading center for efficacy endpoints. The total number of new Gd-enhancing T1 lesions were calculated as the sum of the individual number of new lesions observed at Weeks 4, 8 and 12. The lesion rate (new lesions per scan) was estimated from a negative binomial regression model for the total number of events and w
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 2 |
What the registry record for NCT05119569 still lists
NCT05119569 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 2,165-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (95% lower).
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 lists 17 locations in 3 states (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.
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 NCT05119569's enrollment target sits among peer trials
109 19th of 23 higher than 5 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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