What is BRIUMVI studying for relapsing multiple sclerosis?

BRIUMVI is being studied to understand how much of the medicine passes into breast milk when used by breastfeeding women with relapsing multiple sclerosis. This study aims to provide important information about drug levels in breast milk and potential infant exposure. It is sponsored by TG Therapeutics, Inc.

Who may be eligible for this relapsing multiple sclerosis clinical trial?

Women aged 18 or older with a diagnosis of relapsing forms of multiple sclerosis who are breastfeeding or planning to breastfeed may be eligible. The infant must be born at or after 35 weeks gestation and have a healthy weight above the 10th percentile. Please review eligibility criteria for more details.

Is there any cost to participate in this relapsing multiple sclerosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 18Years +

FEMALE

ID06143514

A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI17 in Breast Milk (PROVIDE)

Led by TG Therapeutics, Inc. · Updated on 2026-05-14

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the presence and concentration of BRIUMVI17 (Ublituximab) in the breast milk of breastfeeding participants who are receiving this treatment for relapsing forms of multiple sclerosis (RMS). This observational study aims to better understand how much of the drug passes into breast milk and could potentially reach the infant. Participants include women diagnosed with RMS who are actively breastfeeding and using BRIUMVI17 therapeutically. During the study, breast milk samples will be collected from participants within 24 hours after receiving BRIUMVI17 to measure the concentration of the drug in the milk. Sampling will occur at multiple timepoints including pre-dose on Day 1 and post-dose on Days 1, 2, 3, 7, 10, 14, 28, 60, and 90. This allows researchers to track how the drug levels change over time in breast milk. Participants will provide regular breast milk samples and continue breastfeeding or pumping as usual during the study. Researchers will measure various drug concentration outcomes in the milk, such as the area under the concentration-time curve, maximum concentration, and amount excreted. Infant health will also be monitored for any adverse events up to about 3 months after the infusion. The study is sponsored by TG Therapeutics, Inc. and will run until June 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Participant has independently decided to be treated with BRIUMVI17 before consenting to the study
Diagnosis of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting MS, or active secondary progressive MS
Willing to breastfeed or pump regularly during the study to maintain milk supply
Plans to continue breastfeeding throughout the study and is not weaning
Infant born at gestational age of 35 weeks or more
Infant birthweight above the 10th percentile
Infant weight above the 10th percentile at enrollment as reported by mother

You will not qualify if you...

Any active infection or condition preventing breastfeeding
History of breast implants, augmentation, or reduction surgery affecting breastfeeding or milk collection
History of mastectomy
Presence of mastitis or other significant breast infection at pre-dose day 1
Current use of drugs known to transfer to breast milk with potential harmful effects on the infant, such as aspirin, tetracyclines, or fluoroquinolones
Infant with any significant medical condition or abnormality, including heart, lung, liver disease, glucose instability, or active infections that may risk infant safety or affect study results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Approximately 3 months

Participants who are receiving BRIUMVI™ therapeutically provide breast milk samples to determine the concentration of BRIUMVI™ in the milk over time.

Multiple sample collections on Day 1 (predose and post-dose), Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60, and Day 90