Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (NCT06594068) | Clinical Trial Compass
RecruitingPhase 4
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
United States16 participantsStarted 2026-01-16
Plain-language summary
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who receive anifrolumab therapeutically.
Who can participate
Age range18 Years – 130 Years
SexFEMALE
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Inclusion criteria
✓. 18 years or older
✓. Signed informed consent to participate
✓. Diagnosis of moderate/severe SLE
✓. Ongoing treatment with anifrolumab
✓. Has reached or will reach steady state (\~85 days postpartum, at least 3 consecutive previous doses during the post-partum period) with anifrolumab by the time of study Day 1 (pre-dose milk collection)1
✓. Established lactation in the index post-partum period (breastfeeding or pumping for at least 4 weeks at time of Day 1 visit to ensure mature milk production)
✓. 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 on Day 1 post IV dose.
✓. Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning
Exclusion criteria
✕. Received any investigational compound or approved biologic or biosimilar within 30 days or 5 half-lives (whichever is longer) prior to enrollment in the study
✕. Diagnosis of lupus nephritis in the last 12 months5
✕. History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts
What they're measuring
1
Area under the milk concentration-time curve during a dosing interval
Timeframe: Approximately 30 days
2
Area under the milk concentration-time curve from time 0 to last quantifiable concentration
Timeframe: Approximately 30 days
3
Average milk concentration at steady state
Timeframe: Approximately 30 days
4
Observed milk concentration at end of dosing interval