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Systemic Lupus ErythematosusPhase 4PRIMULA LacNCT06594068

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

A Phase 4 study testing Anifrolumab in people with Systemic Lupus Erythematosus, run by AstraZeneca at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 130 years, women only
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Anifrolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
16 Jan 2026to 31 Aug 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Maternal:
  • 18 years or older
  • Signed informed consent to participate
  • Diagnosis of moderate/severe SLE
  • Ongoing treatment with anifrolumab
  • 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)
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  • 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)
  • 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
  • Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning
  • 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
  • Agrees to use only lanolin nipple cream during the sampling period
  • Infant:
  • Gestational age at delivery ≥32 weeks
  • Birthweight > 10th percentile
  • Weight > 10th percentile at the time of enrollment

Who cannot join

  • Maternal:
  • 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
  • Diagnosis of lupus nephritis in the last 12 months
  • History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts
  • History of malignancy in the last 10 years
  • History of mastectomy
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

United States1 site, 1 recruiting

  • Research Site

    Las Vegas, Nevada, 89113

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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 via intravenous (IV) or subcutaneous (SC) administration, and to evaluate exposure on the breastfed infant. For participants with IV administration of anifrolumab, 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 on 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. Total duration of participation for each participant with IV administration of anifrolumab will be approximately 1 month.

For participants with SC administration of anifrolumab, the total duration of participation will be approximately 9 days. For these participants, milk collection will occur at a series of 10 timepoints, 1 pre-dose (spot) and 9 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 (prior to next dose, spot). Maternal serum will be collected on Day 1 (pre-dose and 0-4 hours postdose), and approximately Day 8 (immediately preceding subsequent dose). Infant serum will be collected approximately Day 9 following the next dose and after 24 hours of breastfeeding.

Maternal and infant adverse events (AEs) will be actively collected for the duration of participation in the study for IV and SC administration of anifrolumab.

This is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements.

Being tested
Anifrolumab
Keywords
Chronic autoimmune disease, Immunosuppressants, Corticosteroids, Human monoclonal antibody (IgG1ƙ mAb), Post Marketing Requirements (PMR) study, Systemic Lupus Erythematosus (SLE)
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnifrolumabDrug

    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.

Study groups in NCT06594068
Study groupRoleWhat they receive
Anifrolumab (IV administration and SC administration)ExperimentalFor participants with IV administration, milk will be collected at 14 timepoints: 1 pre-dose (spot) and 13 post-dose: Day 1 [0-4, 4-8, 8-12, 12-18, 18-24 hours], Day 3 [48 hours], 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 collection: Day 1 (pre-dose and 0-4 hours post-dose), Day 12, and Day 29. Infant serum collection: Day 30 after the next dose and after 24 hours of breastfeeding. Total duration of participation will be 1 month. For participants with SC administration, the total duration of participation will be 9 days. Milk will be collected at 10 timepoints: 1 pre-dose (spot) and 9 post-dose: Day 1 [0-4, 4-8, 8-12, 12-18, 18-24 hours], Day 3 [48 hours], Day 4 (spot), Day 6 (spot), Day 8 (prior to next dose, spot). Maternal serum collection: Day 1 (pre-dose and 0-4 hours postdose), and Day 8. Infant serum collection: Day 9 after the next dose and after 24 hours of breastfeeding.
Receives: Drug: Anifrolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the milk concentration-time curve during a dosing interval

    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

    Measured: Approximately 30 days

  2. Area under the milk concentration-time curve from time 0 to last quantifiable concentration

    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

    Measured: Approximately 30 days

  3. Average milk concentration at steady state

    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

    Measured: Approximately 30 days

  4. Observed milk concentration at end of dosing interval

    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

    Measured: Approximately 30 days

  5. Maximum observed milk concentration

    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

    Measured: Approximately 30 days

  6. Time of maximum concentration

    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

    Measured: Approximately 30 days

Secondary outcomes (5)

  1. Total amount of drug excreted in milk over 24 hours

    Variable used to assess total amount of drug excreted in milk of lactating individuals. Total amount of drug excreted in milk (mg) over 24 hours calculated as: Σ(total drug concentration in each milk collection x milk volume in each milk collection)

    Measured: Day 1

  2. Fraction of dose excreted in milk

    Variable used to assess fraction of anifrolumab dose excreted in milk of lactating individuals. Fraction of dose excreted in milk, calculated as (Total amount of drug excreted in milk over 24 hours)/Administered dose

    Measured: Day 1

  3. Maternal serum pharmacokinetic (PK) concentrations

    Variable used to assess maternal serum pharmacokinetic (PK) concentrations

    Measured: 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)

  4. Estimates of infant exposure

    Variable used to assess infant anifrolumab exposure (daily infant dosage; relative infant dosage; infant serum anifrolumab concentration)

    Measured: Infant serum will be collected on approximately Day 30 following the next dose and after 24 hours of breast feeding

  5. Maternal and Infant adverse events (AEs)

    Collection of maternal and/or infant AEs during study period. AEs will be summarized by system organ class, preferred term, severity, and causal relationship to anifrolumab

    Measured: Total duration of participation for each participant will be approximately 1 month; data collection is planned for approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start16 Jan 2026
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06594068
Sponsor's protocol ID
D3461R00052
Acronym
PRIMULA Lac
Status last verified
Sep 2026
First submitted
10 Sep 2024
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anifrolumab in people with Systemic Lupus Erythematosus, run by AstraZeneca at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the milk concentration-time curve during a dosing interval (time frame: Approximately 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06594068.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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