NCT06143514Recruiting
A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
TG Therapeutics, Inc.
Start Date
3/26/2024
Completion Date
10/31/2026
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
Maternal Criteria:
* Participant has independently decided to be treated with BRIUMVI™ prior to providing consent to participate in the study
* Diagnosis of RMS, to include clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS)
* Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection Day 1 post IV dose
* Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning
Infant Criteria:
* Gestational age at delivery ≥35 weeks
* Birthweight \> 10th percentile
* Weight \> 10th percentile as reported by the mother at the time of enrollment
Exclusion Criteria:
Maternal Criteria:
* Any active infection or other condition that would prevent the individual from breastfeeding
* History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts
* History of mastectomy
* Evidence of mastitis or any other significant active infection at Day 1 (pre-dose) that would prevent collection of milk from one or both breasts
* Current use of drugs known to transfer to the breast milk and with established or potential deleterious effects for the infant, including but not limited to aspirin (risk of Reye's syndrome), tetracyclines or fluoroquinolones
Infant Criteria:
\- Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant at risk by participating in the study
Interventions
OTHER
No intervention
Conditions
Relapsing Multiple Sclerosis
Locations
PROVIDE Virtual Research Coordination Center
San Francisco, California 94158
United States
PROVIDE Virtual Research Coordination Center
Smyrna, Georgia 30080
United States
TG Therapeutics Investigational Trial Site
Boston, Massachusetts 02115
United States
PROVIDE Virtual Research Coordination Center
Wilmington, North Carolina 28401-3331
United States
PROVIDE Virtual Research Coordination Center
Nashville, Tennessee 37215
United States