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A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
NCT06143514 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).
Conditions Studied
Interventions
- OTHER No intervention
Study Locations (4)
California
- PROVIDE Virtual Research Coordination Center — San Francisco
Georgia
- PROVIDE Virtual Research Coordination Center — Smyrna
North Carolina
- PROVIDE Virtual Research Coordination Center — Wilmington
Tennessee
- PROVIDE Virtual Research Coordination Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-03-26 |
| Est. Completion | 2026-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06143514
The ClinicalTrials.gov registry entry for NCT06143514 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TG Therapeutics, which has 45 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 1 intervention — of which No intervention 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: NCT06143514 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Georgia, North Carolina. 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 NCT06143514 about?
NCT06143514 is a clinical study titled "A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk". The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).
What is the current status of trial NCT06143514?
This trial is currently recruiting. The enrollment target is 16 participants. The study started on 2024-03-26. Estimated completion is 2026-06-30.
What conditions does trial NCT06143514 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 NCT06143514?
The interventions under investigation include: No intervention (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06143514?
This trial is sponsored by TG Therapeutics, which has 45 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06143514 being conducted?
This trial has 4 study locations across California, Georgia, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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