Studying how a lupus medication passes into breast milk

Plain-English translation of NCT06594068 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated June 2026 · How we translate trials

Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.

What is this trial?

Researchers want to understand how —a medication used to treat moderate to severe lupus—passes into breast milk and whether it could affect a breastfed baby. This study will collect breast milk and blood samples from mothers taking this medication, as well as blood samples from their infants, to measure how much of the medication the baby is exposed to through breastfeeding.

Many women with lupus want to breastfeed their babies while continuing their treatment, but doctors don't have enough information about whether this medication is safe during breastfeeding. This study will provide that important safety information so mothers and their doctors can make confident decisions together.

Do you qualify?

You likely qualify if…

you are at least 18 years old
you have been diagnosed with moderate to severe lupus (SLE)
you are currently receiving the medication as treatment
you have been breastfeeding or pumping for at least 4 weeks
your baby was born at 32 weeks gestation or later and has a normal birth weight

You likely don't qualify if…

you have been diagnosed with lupus kidney disease in the past 12 months
you have had breast surgery (implants, augmentation, reduction, or mastectomy) that affects milk production
you have a history of cancer in the past 10 years
you have an active infection like mastitis at the time of enrollment
your baby has a significant medical condition like heart, lung, or liver disease

What participation looks like

You will provide breast milk samples at multiple time points over either about 1 month (if receiving IV medication) or about 9 days (if receiving the medication by injection). You'll also have blood samples taken a few times, and your baby will have one blood sample collected around day 9 or 30. During the collection period, you'll pump exclusively for 24 hours to ensure clean samples. The study team will monitor both you and your baby for any side effects throughout your participation.

AI-generated summary from trial data · Jun 26, 2026 · Not medical advice

Trial locations(1 site)

United States

Research Site, Las Vegas, Nevada