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

Relapsing Multiple Sclerosis Clinical Trial

— PROVIDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143514
• Other study ID #: TG1101-RMS405
• Status: Recruiting
• Start date: March 26, 2024
• Est. completion date: June 28, 2025

Study information

• Verified date: April 2024
• Source: TG Therapeutics, Inc.
• Contact: PROVIDE Virtual Research Coordination Center
• Phone: 1-877-296-4411
• Email: briumvi_lactationstudy[@]ppd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 28, 2025
• Est. primary completion date: June 28, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	PROVIDE Virtual Research Coordination Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
TG Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Amount Excreted (Ae) of BRIUMVI™ in Milk	Total amount of drug excreted in milk (mg) as: S(total drug concentration in each milk collection x milk volume in each milk collection)	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	Fraction of Dose Excreted (Fe) in Milk of BRIUMVI™	Fraction of dose excreted in milk calculated as Ae/Administered dose	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	Infant Dose (ID) of BRIUMVI™	Infant dose = ? drug concentration in each milk collection multiplied by the expressed milk volume in each milk collection.	Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and at exit Day 90
Secondary	Relative Infant Dose (RID) of BRIUMVI™	Relative infant dose = infant dose milligrams/kilograms (mg/kg)/ [Maternal Dose (mg)/Maternal Bodyweight (kg)] multiplied by 100	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	Number of Infants with Adverse Events		From the signing the inform consent form up to approximately 3 months after the index infusion