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New study checks how much MS drug gets into breast milk

NCT ID NCT06143514

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • PROVIDE Virtual Research Coordination Center

    RECRUITING

    San Francisco, California, 94158, United States

  • PROVIDE Virtual Research Coordination Center

    RECRUITING

    Smyrna, Georgia, 30080, United States

  • PROVIDE Virtual Research Coordination Center

    RECRUITING

    Wilmington, North Carolina, 28401-3331, United States

  • PROVIDE Virtual Research Coordination Center

    RECRUITING

    Nashville, Tennessee, 37215, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

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