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

Launched by TG THERAPEUTICS, INC. · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called BRIUMVI™ (also known as Ublituximab) affects breast milk in women who are breastfeeding and have relapsing multiple sclerosis (RMS). The main goal is to find out if BRIUMVI™ is present in breast milk and, if so, how much of it is there. This information will help understand the safety of breastfeeding while receiving this treatment.

To participate in this study, women must be diagnosed with RMS and have decided to use BRIUMVI™ as part of their treatment plan. They should be willing to regularly breastfeed or pump milk during the study and continue doing so throughout. Their infants should be born at least 35 weeks into the pregnancy and have a healthy weight. Participants should be free of any infections or conditions that could interfere with breastfeeding. Throughout the trial, mothers will provide breast milk samples, and the study team will monitor both the mothers and infants to ensure their health and safety.

Gender

FEMALE

Eligibility criteria

• 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