Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
NCT05119569 · View on ClinicalTrials.gov ↗
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
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05119569 reports 17 study locations spanning 3 distinct geographic areas — top geographies include Other, California, Nevada. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05119569?
The interventions under investigation include: Placebo (DRUG), Fenebrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05119569?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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