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RECRUITING

NCT06594068

PHASE4

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-16

Completion Date

2027-08-31

Last Updated

2026-06-26

Healthy Volunteers

Conditions

Systemic Lupus Erythematosus

Interventions

DRUG

Anifrolumab

Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor, which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE (Furie et al., 2017). Clinical trial evidence from TULIP 1, TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group-based Composite Lupus Assessment, compared with patients receiving placebo (Furie et al., 2019; Morand et al., 2020). The phase II MUSE study showed that administration of anifrolumab resulted in substantially reduced disease activity, measured by the SLE Responder Index, compared to patients receiving placebo (Furie et al., 2017). These data resulted with applications to the FDA and the EMA, leading to approvals in July 2021 and February 2022, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.

Inclusion Criteria: Maternal: 1. 18 years or older 2. Signed informed consent to participate 3. Diagnosis of moderate/severe SLE 4. Ongoing treatment with anifrolumab 5. Has reached or will reach steady state (\~85 days postpartum, equivalent to at least 3 consecutive previous IV doses or at least 12 previous SC doses during the post-partum period) with anifrolumab by the time of study Day 1 (pre-dose milk collection) 6. 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) 7. 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 8. Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning 9. 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 10. Agrees to use only lanolin nipple cream during the sampling period Infant: 1. Gestational age at delivery ≥32 weeks 2. Birthweight \> 10th percentile 3. Weight \> 10th percentile at the time of enrollment Exclusion Criteria: Maternal: 1. 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 2. Diagnosis of lupus nephritis in the last 12 months 3. History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts 4. History of malignancy in the last 10 years 5. History of mastectomy 6. Evidence of mastitis or any other significant active infection at Day 1 (pre-dose) Infant: 1\. Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant participant at risk by participating in the study

Locations (1)

Research Site

Las Vegas, Nevada, United States