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

NCT06143514 | Recruiting FDA Drug

• 1 other identifier: TG1101-RMS405
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 4

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).

Conditions

Relapsing Multiple Sclerosis

Keywords

Multiple Sclerosis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• Number of Infants with Adverse Events

  From the signing the inform consent form up to approximately 3 months after the index infusion

Study Arms (1)

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

Interventions

No intervention OTHER

No intervention

Breast Milk Collection

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study population is restricted to breastfeeding participants.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include breastfeeding individuals with RMS who are exposed to BRIUMVI™.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TG Therapeutics, Inc.: lead

Study Sites (4)

PROVIDE Virtual Research Coordination Center

San Francisco, California, 94158, United States

RECRUITING

PROVIDE Virtual Research Coordination Center

Smyrna, Georgia, 30080, United States

RECRUITING

PROVIDE Virtual Research Coordination Center

Wilmington, North Carolina, 28401-3331, United States

RECRUITING

PROVIDE Virtual Research Coordination Center

Nashville, Tennessee, 37215, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

PROVIDE Virtual Research Coordination Center

CONTACT

1-877-296-4411; briumvi_lactationstudy@ppd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: March 26, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)