Clinical Trials in the USA / NCT06143514
Active, not recruiting
Observational
A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
NCT06143514 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Relapsing Multiple Sclerosis
Investigational drug(s) / intervention(s)
No intervention
No intervention: No intervention
Study 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
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
Primary outcome measure(s)
- Area Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™ — 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
- Area Under the Milk Concentration-time Curve from Time 0 to the Last Measurable Observed Concentration (AUC0-last) of BRIUMVI™ — 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
- Area Under the Milk Concentration-Time Curve from Time 0 to 24 Hours Post-Dose (AUC0-24) of BRIUMVI™ — 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
- Maximum Observed Milk Concentration of BRIUMVI™ (Cmax) — 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
- Observed Milk Concentration of BRIUMVI™ at End of Dosing Interval (Ctrough) of BRIUMVI™ — 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 at exit Day 90
- Time of Cmax (Tmax) of BRIUMVI™ in Milk — 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
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| PROVIDE Virtual Research Coordination Center | San Francisco | California | |
| PROVIDE Virtual Research Coordination Center | Smyrna | Georgia | |
| TG Therapeutics Investigational Trial Site | Boston | Massachusetts | |
| PROVIDE Virtual Research Coordination Center | Wilmington | North Carolina | |
| PROVIDE Virtual Research Coordination Center | Nashville | Tennessee |
More TG Therapeutics, Inc. trials in the USA
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06143514 on ClinicalTrials.gov ↗ ← All trials in the USA