Clinical Trial

Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users

Study acronym: PRIMULA Lac
Recruiting Phase 4
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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 are receiving anifrolumab therapeutically via intravenous (IV) or subcutaneous (SC) administration and evaluate exposure and effects on the breastfed infant.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2024-09-10; most recent amendment 2026-07-20.
Status change: Not Yet Recruiting → Recruiting 2024-11-18
Trial Details
NCT Number NCT06594068
Lead Sponsor AstraZeneca
Collaborators: PPD Development, LP
Conditions Systemic Lupus Erythematosus
Enrollment 16 participants
Start Date 2026-01-16
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-21