Investigating outcomes in mothers and infants using Anifrolumab

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

This study is testing whether Anifrolumab, a medication for lupus, shows up in breast milk and affects breastfeeding mothers and their infants.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 130 Years
• Sex: Female
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: anifrolumab
• Locations: 1 site (Las Vegas, Nevada)
• Trial ID: NCT06594068 on ClinicalTrials.gov

What this trial studies

This study is a prospective registry designed to assess the presence of Anifrolumab in breast milk and serum among lactating individuals receiving the medication for systemic lupus erythematosus. It involves open enrollment and will collect data at multiple timepoints, including maternal serum and breast milk samples, as well as infant serum samples. The study aims to evaluate the exposure of breastfed infants to Anifrolumab and monitor any adverse events in both mothers and infants during the study period.

Who should consider this trial

Good fit: Ideal candidates for this study are lactating women aged 18 and older who are receiving Anifrolumab for moderate to severe systemic lupus erythematosus.

Not a fit: Patients who are not currently breastfeeding or who are not receiving Anifrolumab therapeutically may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical information on the safety and effects of Anifrolumab during breastfeeding, helping to guide treatment decisions for lactating mothers with systemic lupus erythematosus.

How similar studies have performed: While this study is part of post-marketing requirements, similar studies investigating drug exposure in breastfeeding have shown success in providing valuable safety data.

Eligibility criteria

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, 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
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 months5
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

Where this trial is running

Las Vegas, Nevada

• Research Site — Las Vegas, Nevada, United States (Recruiting)

Study contacts

• Principal investigator: Darin Brimhall, MD — PPD, Las Vegas, US
• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Systemic Lupus Erythematosus; Chronic autoimmune disease; Immunosuppressants; Corticosteroids; Human monoclonal antibody; Post Marketing Requirements study