PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:

‣ Maternal:

• 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

• Must be exclusively breast milk-feeding their infant (or if not exclusively breast milk-feeding, not providing more than 1 supplemental bottle of formula per day) at the time of enrollment and throughout the study period

⁃ Agrees to use only lanolin nipple cream during the sampling period

‣ Infant:

• Gestational age at delivery ≥32 weeks

• Birthweight \> 10th percentile

• Weight \> 10th percentile at the time of enrollment

Locations
United States
Nevada
Research Site
RECRUITING
Las Vegas
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2026-01-30
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 16
Treatments
Experimental: Anifrolumab
Lactating individuals 18 years of age or older receiving anifrolumab therapeutically who provide consent to participate will be included in the study. Milk collection will occur at a series of 14 timepoints, 1 pre-dose (spot) and 13 post-dose: Day 1 \[0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, 18-24 hours\], Day 3 \[48 hours, spot\], Day 4 (spot), Day 6 (spot), Day 8 (spot), Day 12 (spot), Day 16 (spot), Day 22 (spot), and Day 29 (prior to next dose, spot). Maternal serum will be collected Day 1 (pre-dose and 0-4 hours post-dose), Day 12, and approximately Day 29 (immediately preceding subsequent dose). Infant serum will be collected on approximately Day 30 following the next dose and after 24 hours of breast feeding.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: PPD Development, LP

This content was sourced from clinicaltrials.gov