Actively Recruiting
A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
Led by TG Therapeutics, Inc. · Updated on 2026-05-14
16
Participants Needed
5
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has independently decided to be treated with BRIUMVI™ before consenting to the study
- Diagnosis of relapsing multiple sclerosis including clinically isolated syndrome, relapsing-remitting MS, or active secondary progressive MS
- Willing to breastfeed or pump regularly during the study and exclusively pump breast milk for 24 hours on Day 1 after intravenous dose
- Plans to continue feeding infant breast milk throughout the study and is not weaning
- Infant gestational age at delivery is at least 35 weeks
- Infant birthweight is above the 10th percentile
- Infant weight at enrollment is above the 10th percentile as reported by the mother
You will not qualify if you...
- Any active infection or condition preventing breastfeeding
- History of breast implants, augmentation, or reduction surgery significantly affecting breastfeeding or milk collection
- History of mastectomy
- Evidence of mastitis or significant active infection at Day 1 preventing milk collection
- Current use of drugs known to transfer into breast milk with known or potential harmful effects to the infant, including aspirin, tetracyclines, or fluoroquinolones
- Infant has any abnormality or significant medical condition such as cardiac, pulmonary, liver disease, glucose instability, or active infection that may interfere with study or pose risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
PROVIDE Virtual Research Coordination Center
San Francisco, California, United States, 94158
Actively Recruiting
2
PROVIDE Virtual Research Coordination Center
Smyrna, Georgia, United States, 30080
Actively Recruiting
3
TG Therapeutics Investigational Trial Site
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
PROVIDE Virtual Research Coordination Center
Wilmington, North Carolina, United States, 28401-3331
Actively Recruiting
5
PROVIDE Virtual Research Coordination Center
Nashville, Tennessee, United States, 37215
Actively Recruiting
Research Team
P
PROVIDE Virtual Research Coordination Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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