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

We're studying BRIUMVI™ levels in breast milk.

Recruiting
18 years and older
Female
Phase N/A

This study looks at how much BRIUMVI™ (Ublituximab) is found in breast milk. BRIUMVI™ is a medicine used to treat relapsing forms of multiple sclerosis (RMS), a disease that affects the brain and spinal cord. The study is for breastfeeding moms who are already using BRIUMVI™. Moms need to be willing to pump breast milk during the study; especially on Day 1 right after getting their IV dose. Both mom and baby should meet certain health criteria to join the study. Moms should not have any active infections or a history of breast surgeries that could affect breastfeeding. Babies should be born at 35 weeks or later and be at a healthy weight. Risks include potential side effects from the medicine to the baby, so moms using certain drugs that pass into breast milk can't participate.

  • The study involves collecting breast milk on Day 1 after IV dose.
  • Moms must already be using BRIUMVI™ and willing to pump milk during the study.
  • Both mother and baby need to meet health criteria to join.
Study details
    Relapsing Multiple Sclerosis

NCT06143514

TG Therapeutics, Inc.

7 March 2026

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