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

Official title

A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI™ in Breast Milk (PROVIDE)

Overview

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).

Interventions

• Other No intervention
  No intervention

Primary outcome measures

• Area Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™ [Time frame: 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™ [Time frame: 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™ [Time frame: 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) [Time frame: 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™ [Time frame: 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 [Time frame: 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]

Secondary outcome measures (5)

• Amount Excreted (Ae) of BRIUMVI™ in Milk [Time frame: 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]
• Fraction of Dose Excreted (Fe) in Milk of BRIUMVI™ [Time frame: 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]
• Infant Dose (ID) of BRIUMVI™ [Time frame: Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and at exit Day 90]
• Relative Infant Dose (RID) of BRIUMVI™ [Time frame: 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]
• Number of Infants with Adverse Events [Time frame: From the signing the inform consent form up to approximately 3 months after the index infusion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 5 centers

• PROVIDE Virtual Research Coordination Center — San Francisco
• PROVIDE Virtual Research Coordination Center — Smyrna
• TG Therapeutics Investigational Trial Site — Boston
• PROVIDE Virtual Research Coordination Center — Wilmington
• PROVIDE Virtual Research Coordination Center — Nashville

Identifiers

NCT: NCT06143514 · TG1101-RMS405

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗