Clinical trial NCT06594068: Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
Official title: PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Systemic Lupus Erythematosus
Keywords: Chronic autoimmune disease
Immunosuppressants
Corticosteroids
Human monoclonal antibody (IgG1ƙ mAb)
Post Marketing Requirements (PMR) study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2024-09-19
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: PRIMULA Lac is an open-label, open enrollment, post marketing study to assess concentrations of anifrolumab in breast milk and serum in lactating individuals who are receiving anifrolumab therapeutically, and to evaluate exposure on the breastfed infant. Milk collection will occur at a series of 14 timepoints. 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. Maternal and infant adverse events (AEs) will be actively collected for the duration of the study. Total duration of participation for each participant will be approximately 1 month. The objective of this lactation study is to assess presence of anifrolumab in breast milk and serum (maternal and infant) among lactating individuals who receive anifrolumab therapeutically and to evaluate exposure in the breastfed infant. This is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements.

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

Primary outcomes:
measure: Area under the milk concentration-time curve during a dosing interval
timeFrame: Approximately 30 days
measure: Area under the milk concentration-time curve from time 0 to last quantifiable concentration
timeFrame: Approximately 30 days
measure: Average milk concentration at steady state
timeFrame: Approximately 30 days
measure: Observed milk concentration at end of dosing interval
timeFrame: Approximately 30 days
measure: Maximum observed milk concentration
timeFrame: Approximately 30 days
measure: Time of maximum concentration
timeFrame: Approximately 30 days
Secondary outcomes:
measure: Total amount of drug excreted in milk over 24 hours
timeFrame: Day 1
measure: Fraction of dose excreted in milk
timeFrame: Day 1
measure: Maternal serum pharmacokinetic (PK) concentrations
timeFrame: 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)
measure: Estimates of infant exposure
timeFrame: Infant serum will be collected on approximately Day 30 following the next dose and after 24 hours of breast feeding
measure: Maternal and Infant adverse events (AEs)
timeFrame: Total duration of participation for each participant will be approximately 1 month; data collection is planned for approximately 3 years
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
Study officials:
affiliation: PPD, Las Vegas, US
name: Darin Brimhall, MD
role: PRINCIPAL_INVESTIGATOR
References: