Multiple Sclerosis Trial, Recruiting NCT06143514 Sponsor: TG Therapeutics, Inc. Condition: Multiple Sclerosis
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Multiple Sclerosis Trial, Recruiting

NCT06143514
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For the mother:

  • You have already independently decided to be treated with BRIUMVI™ before agreeing to take part in this study
  • You have been diagnosed with a relapsing form of multiple sclerosis, which includes clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS)
  • You are willing to breastfeed or pump regularly during the study, and are willing to pump exclusively for a 24-hour period on the first day after receiving your IV dose
  • You plan to continue feeding your baby breast milk throughout the entire study and are not currently in the process of weaning

For the baby:

  • Your baby was born at 35 weeks of pregnancy or later
  • Your baby's birth weight was above the 10th percentile (not among the lowest 10% of birth weights)
  • Your baby's current weight is above the 10th percentile, as reported by you at enrollment

Who may not be able to join:

For the mother:

  • You have an active infection or any other condition that would stop you from breastfeeding
  • You have had breast implants, breast augmentation, or breast reduction surgery that significantly affects your ability to breastfeed or collect milk from one or both breasts
  • You have had a mastectomy (surgical removal of a breast)
  • You show signs of a breast infection (mastitis) or any other significant active infection on the first day of the study that would prevent milk collection from one or both breasts
  • You are currently taking certain medicines known to pass into breast milk and that could be harmful to your baby, including but not limited to aspirin, tetracyclines, or fluoroquinolones (confirm specific medications with trial site)

For the baby:

  • Your baby has any notable health condition or abnormality — such as heart, lung, or liver problems, unstable blood sugar, or an active infection — that the study doctor believes could make participation risky or affect the study results (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 1-877-296-4411

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
TG Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
26 March 2024
Est. completion
30 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Area Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™; Area Under the Milk Concentration-time Curve from Time 0 to the Last Measurable Observed Concentration (AUC0-last) of BRIUMVI™; Area Under the Milk Concentration-Time Curve from Time 0 to 24 Hours Post-Dose (AUC0-24) of BRIUMVI™; Maximum Observed Milk Concentration of BRIUMVI™ (Cmax); Observed Milk Concentration of BRIUMVI™ at End of Dosing Interval (Ctrough) of BRIUMVI™; Time of Cmax (Tmax) of BRIUMVI™ in Milk

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov