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

Recruiting

• Conditions: Relapsing Multiple Sclerosis

• Registration Number: NCT06143514
• Lead Sponsor: TG Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br>Maternal Criteria:<br><br> - Participant has independently decided to be treated with BRIUMVI™ prior to providing<br> consent to participate in the study<br><br> - Diagnosis of RMS, to include clinically isolated syndrome (CIS), relapsing-remitting<br> multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis<br> (SPMS)<br><br> - Willing to breastfeed or pump regularly during the study period to maintain milk<br> supply and exclusively pump breast milk for the 24-hour period of breast milk<br> collection Day 1 post IV dose<br><br> - Plans to continue feeding infant breast milk at least throughout the duration of the<br> study and is not weaning<br><br>Infant Criteria:<br><br> - Gestational age at delivery =35 weeks<br><br> - Birthweight > 10th percentile<br><br> - Weight > 10th percentile as reported by the mother at the time of enrollment<br><br>Exclusion Criteria:<br><br>Maternal Criteria:<br><br> - Any active infection or other condition that would prevent the individual from<br> breastfeeding<br><br> - History of breast implants, breast augmentation, or breast reduction surgery that<br> significantly impacts breastfeeding or collection of milk from 1 or both breasts<br><br> - History of mastectomy<br><br> - Evidence of mastitis or any other significant active infection at Day 1 (pre-dose)<br> that would prevent collection of milk from one or both breasts<br><br> - Current use of drugs known to transfer to the breast milk and with established or<br> potential deleterious effects for the infant, including but not limited to aspirin<br> (risk of Reye's syndrome), tetracyclines or fluoroquinolones<br><br>Infant Criteria:<br><br> - Any abnormality noted or clinically significant medical condition, including<br> cardiac, pulmonary, and liver disease, glucose instability, or active infection at<br> the time of screening that, in the opinion of the investigator, may make<br> implementation of the protocol or interpretation of the trial difficult or would put<br> the infant at risk by participating in the study

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™;Area Under the Milk Concentration-time Curve from Time 0 to the Last Measurable Observed Concentration (AUC0-last) of BRIUMVI™;Area Under the Milk Concentration-Time Curve from Time 0 to 24 Hours Post-Dose (AUC0-24) of BRIUMVI™;Maximum Observed Milk Concentration of BRIUMVI™ (Cmax);Observed Milk Concentration of BRIUMVI™ at End of Dosing Interval (Ctrough) of BRIUMVI™;Time of Cmax (Tmax) of BRIUMVI™ in Milk

Secondary Outcome Measures

Name	Time	Method
Amount Excreted (Ae) of BRIUMVI™ in Milk;Fraction of Dose Excreted (Fe) in Milk of BRIUMVI™;Infant Dose (ID) of BRIUMVI™;Relative Infant Dose (RID) of BRIUMVI™;Number of Infants with Adverse Events