New study checks how much MS drug gets into breast milk
NCT ID NCT06143514
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This study looks at how much of the multiple sclerosis drug BRIUMVI gets into breast milk. About 16 breastfeeding women with relapsing MS will provide milk samples after their regular treatment. The goal is to understand drug exposure for nursing infants, not to test a new treatment.
Why investors are watching
TG Therapeutics is running a small study to measure whether its multiple sclerosis drug, BRIUMVI, passes into breast milk. For a small-cap company, this readout matters because it could expand the drug's label to include breastfeeding women, a group often excluded from treatment options. The result is consequential because it addresses a practical gap in patient care that could support broader adoption of the drug.
If it works: A positive result showing low or no drug in breast milk could allow TG Therapeutics to update the drug's label, making it a more attractive option for women with relapsing MS who want to breastfeed. That could widen the drug's use without needing a large new trial.
If it fails: If the study shows meaningful drug levels in breast milk, or if it is delayed or fails to enroll enough participants, the company may not get the label update. Trials of this size often face recruitment challenges, and a negative or inconclusive result would leave the current prescribing situation unchanged.
AI-written from the trial record. Speculative, and not investment advice.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will include breastfeeding individuals with RMS who are exposed to BRIUMVI™.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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PROVIDE Virtual Research Coordination Center
RECRUITINGSan Francisco, California, 94158, United States
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PROVIDE Virtual Research Coordination Center
RECRUITINGSmyrna, Georgia, 30080, United States
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PROVIDE Virtual Research Coordination Center
RECRUITINGWilmington, North Carolina, 28401-3331, United States
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PROVIDE Virtual Research Coordination Center
RECRUITINGNashville, Tennessee, 37215, United States
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TG Therapeutics Investigational Trial Site
RECRUITINGBoston, Massachusetts, 02115, United States
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