A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
← catalyst calendarNCT06143514 · readout in 72 d
Sponsored by TG Therapeutics, Inc. (industry) · TGTX — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
16estimated
Sites
5
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-03-26 | actual | When the study began enrolling |
| Primary completion | 2026-10-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-10-31 | estimated | The whole study's end, after follow-up |
| First posted | 2023-11-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Relapsing Multiple Sclerosis
Intervention
- Other: No intervention
Primary outcomes
what the primary-completion date above is the date OFArea Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™
measured Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
Area Under the Milk Concentration-time Curve from Time 0 to the Last Measurable Observed Concentration (AUC0-last) of BRIUMVI™
measured Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
Area Under the Milk Concentration-Time Curve from Time 0 to 24 Hours Post-Dose (AUC0-24) of BRIUMVI™
measured Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
Maximum Observed Milk Concentration of BRIUMVI™ (Cmax)
measured Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
Observed Milk Concentration of BRIUMVI™ at End of Dosing Interval (Ctrough) of BRIUMVI™
measured Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and at exit Day 90
Time of Cmax (Tmax) of BRIUMVI™ in Milk
measured Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
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