Actively Recruiting
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
Led by AstraZeneca · Updated on 2026-05-12
16
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
PPD Development, LP
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Signed informed consent to participate
- Diagnosis of moderate/severe SLE
- Ongoing treatment with anifrolumab
- Reached or will reach steady state (~85 days postpartum, at least 3 previous consecutive doses) by Day 1
- Established lactation in the current postpartum period (breastfeeding or pumping at least 4 weeks at Day 1)
- Willingness to breastfeed or pump regularly and exclusively pump breast milk during 24-hour collection on Day 1
- Plans to continue feeding infant breast milk throughout the study and is not weaning
- Exclusively breast milk-feeding infant or providing no more than 1 supplemental formula bottle per day at enrollment and during study
- Agreement to use only lanolin nipple cream during sampling period
- Infant gestational age at delivery ≥32 weeks
- Infant birthweight >10th percentile
- Infant weight >10th percentile at enrollment
You will not qualify if you...
- Received any investigational compound or approved biologic or biosimilar within 30 days or 5 half-lives prior to enrollment
- Diagnosis of lupus nephritis within last 12 months
- History of breast implants, augmentation, or reduction surgery significantly impacting breastfeeding or milk collection
- History of malignancy in last 10 years
- History of mastectomy
- Evidence of mastitis or other significant active infection at Day 1 (pre-dose)
- Infant has any abnormality or significant medical condition (cardiac, pulmonary, liver disease, glucose instability, active infection) at screening that may affect study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site
Las Vegas, Nevada, United States, 89113
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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