RecruitingPhase 4NCT06594068

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

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

Sponsor

AstraZeneca

Enrollment

16 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Anifrolumab for people with systemic lupus erythematosus. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 130 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnifrolumab

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.