A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk

Part of paid clinical trials in San Francisco, California.

Sponsor
TG Therapeutics, Inc.
Study ID
NCT06143514
Status
Recruiting
Apply to this trial

Conditions

  • Relapsing Multiple Sclerosis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • No intervention — OTHER
    No intervention

Study Details

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).

Key Dates

Start date
Mar 26, 2024
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
16 participants (estimated)

Arms

  • Arm: Breast Milk Collection
    Breast milk will be collected of participants with relapsing forms of multiple sclerosis (RMS) who are receiving BRIUMVI™ therapeutically for up to 24 hours to determine concentration of BRIUMVI™ in milk samples.

Primary Outcome Measure

Area Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™ [ Time Frame: 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 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
PROVIDE Virtual Research Coordination CenterSan FranciscoCalifornia94158
[email protected]
415-502-7209
PROVIDE Virtual Research Coordination CenterSmyrnaGeorgia30080-
TG Therapeutics Investigational Trial SiteBostonMassachusetts02115-
PROVIDE Virtual Research Coordination CenterWilmingtonNorth Carolina28401-3331-
PROVIDE Virtual Research Coordination CenterNashvilleTennessee37215-

Find similar trials in San Francisco, CA

By research site
PROVIDE Virtual Research Coordination Center· San Francisco, CAPROVIDE Virtual Research Coordination Center· Smyrna, GATG Therapeutics Investigational Trial Site· Boston, MAPROVIDE Virtual Research Coordination Center· Wilmington, NCPROVIDE Virtual Research Coordination Center· Nashville, TN

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