PROVIDE: A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Breast Milk Collection 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
No intervention
|
Outcome Measures
Primary Outcome Measures
- 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
- Amount Excreted (Ae) 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]
Total amount of drug excreted in milk (mg) as: Σ(total drug concentration in each milk collection x milk volume in each milk collection)
- Fraction of Dose Excreted (Fe) in Milk 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]
Fraction of dose excreted in milk calculated as Ae/Administered dose
- Infant Dose (ID) of BRIUMVI™ [Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and at exit Day 90]
Infant dose = Ʃ drug concentration in each milk collection multiplied by the expressed milk volume in each milk collection.
- Relative Infant Dose (RID) 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]
Relative infant dose = infant dose milligrams/kilograms (mg/kg)/ [Maternal Dose (mg)/Maternal Bodyweight (kg)] multiplied by 100
- Number of Infants with Adverse Events [From the signing the inform consent form up to approximately 3 months after the index infusion]
Eligibility Criteria
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
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Birthweight > 10th percentile
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Weight > 10th percentile as reported by the mother at the time of enrollment
Exclusion Criteria:
Maternal Criteria:
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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
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History of mastectomy
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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
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- TG Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TG1101-RMS405