Clinical trial NCT06143514: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Relapsing Multiple Sclerosis
Keywords: Multiple Sclerosis
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-22
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include breastfeeding individuals with RMS who are exposed to BRIUMVI™.

Brief 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: 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 outcomes:
measure: Area Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™
timeFrame: 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
measure: Area Under the Milk Concentration-time Curve from Time 0 to the Last Measurable Observed Concentration (AUC0-last) of BRIUMVI™
timeFrame: 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
measure: Area Under the Milk Concentration-Time Curve from Time 0 to 24 Hours Post-Dose (AUC0-24) of BRIUMVI™
timeFrame: 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
measure: Maximum Observed Milk Concentration of BRIUMVI™ (Cmax)
timeFrame: 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
measure: Observed Milk Concentration of BRIUMVI™ at End of Dosing Interval (Ctrough) of BRIUMVI™
timeFrame: 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
measure: Time of Cmax (Tmax) of BRIUMVI™ in Milk
timeFrame: 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 outcomes:
measure: Amount Excreted (Ae) of BRIUMVI™ in Milk
timeFrame: 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
measure: Fraction of Dose Excreted (Fe) in Milk of BRIUMVI™
timeFrame: 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
measure: Infant Dose (ID) of BRIUMVI™
timeFrame: Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and at exit Day 90
measure: Relative Infant Dose (RID) of BRIUMVI™
timeFrame: 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
measure: Number of Infants with Adverse Events
timeFrame: From the signing the inform consent form up to approximately 3 months after the index infusion
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: PROVIDE Virtual Research Coordination Center
state: North Carolina
Study officials:
References: