---
title: Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
nct_id: NCT06594068
overall_status: RECRUITING
phase: PHASE4
sponsor: AstraZeneca
study_type: INTERVENTIONAL
primary_condition: Systemic Lupus Erythematosus
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06594068.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06594068"
ct_last_update_post_date: 2026-04-13
last_seen_at: "2026-05-12T06:51:02.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT06594068](https://clinicaltrials.gov/study/NCT06594068)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 16
- **Lead Sponsor:** AstraZeneca
- **Collaborators:** PPD Development, LP
- **Conditions:** Systemic Lupus Erythematosus
- **Start Date:** 2026-01-16
- **Completion Date:** 2027-08-31
- **CT.gov Last Update:** 2026-04-13

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 130 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Anifrolumab** (EXPERIMENTAL) — 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.

## Interventions

- **Anifrolumab** (DRUG) — 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 2017). Clinical trial evidence from TULIP 1 and 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 2019; Morand 2020). Moreover, the phase II MUSE study showed that administration of anifrolumab resulted in substantially reduce disease activity, as measured by the SLE Responder Index, compared to patients receiving placebo (Furie 2017). These data resulted with applications to the FDA and the EMA, leading to approval by them in July 2021 and February 2022, respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.

## Primary Outcomes

- **Area under the milk concentration-time curve during a dosing interval** _(time frame: Approximately 30 days)_ — Area under the milk concentration-time curve during a dosing interval is a component used to assess pharmacokinetic (PK) of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using the concentration-time data for all evaluable participants included in the PK population
- **Area under the milk concentration-time curve from time 0 to last quantifiable concentration** _(time frame: Approximately 30 days)_ — Area under the milk concentration-time curve from time 0 to last quantifiable concentration is a component used to assess PK of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using the concentration-time data for all evaluable participants included in the PK population
- **Average milk concentration at steady state** _(time frame: Approximately 30 days)_ — Average milk concentration at steady state is a component used to assess PK of anifrolumab in milk of lactating individuals. It will be calculated dividing "Area under the milk concentration-time curve during a dosing interval" by the dosing interval for anifrolumab
- **Observed milk concentration at end of dosing interval** _(time frame: Approximately 30 days)_ — Observed milk concentration at end of dosing interval is a component used to assess PK of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using data for all evaluable participants included in the PK population
- **Maximum observed milk concentration** _(time frame: Approximately 30 days)_ — Maximum observed milk concentration is a component used to assess PK of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using data for all evaluable participants included in the PK population
- **Time of maximum concentration** _(time frame: Approximately 30 days)_ — Time of maximum concentration is a component used to assess PK of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using data for all evaluable participants included in the PK population

## Secondary Outcomes

- **Total amount of drug excreted in milk over 24 hours** _(time frame: Day 1)_
- **Fraction of dose excreted in milk** _(time frame: Day 1)_
- **Maternal serum pharmacokinetic (PK) concentrations** _(time frame: 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))_
- **Estimates of infant exposure** _(time frame: 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)** _(time frame: Total duration of participation for each participant will be approximately 1 month; data collection is planned for approximately 3 years)_

## Locations (1)

- Research Site, Las Vegas, Nevada, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.research site|las vegas|nevada|united states` — added _(2026-05-12)_

---

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