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NCT06594068Phase 4RECRUITING

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

Study 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.

Conditions
Systemic Lupus Erythematosus
Interventions / Drugs
Anifrolumab
View on ClinicalTrials.gov ↗
Sponsor
AZN
AstraZeneca
Oncology/Respiratory
F16/100
Study Details
Enrollment16 participants
Primary Completion—
Lead SponsorAstraZeneca
Data Retrieved2026-04-11 02:55:19.909479+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

This trial phase represents an early or specialized stage of clinical development.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 16 participants
Sponsor Catalyst Profile

AstraZeneca (AZN) is the sponsoring company for this trial. BiotechSign currently grades this company F (16/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

AZN Full Pipeline →All Companies →
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