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

Study Overview
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Brief Summary
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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).

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

Conditions
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Relapsing Multiple Sclerosis

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Milk Collection<br>Breast milk will be collected of participants with relapsing forms of multiple sclerosis (RMS) who are receiving BRIUMVI™ therapeutically for up to 24 hours to determine concentration of BRIUMVI™ in milk samples. | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount Excreted (Ae) of BRIUMVI™ in Milk | Total amount of drug excreted in milk (mg) as: Σ(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 | 
| 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 | 
| Infant Dose (ID) of BRIUMVI™ | Infant dose = Ʃ 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 | 
| 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 | 
| Number of Infants with Adverse Events |  | From the signing the inform consent form up to approximately 3 months after the index infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis