Recruiting

Anifrolumab

Sponsor:

AstraZeneca

Code:

NCT06659029

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Anifrolumab

Study Details

Brief summary:

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT06659029

Start date

Jul 1, 2025

Status verified date

Aug, 2026

Completion date

Apr 15, 2031

Anticipated

Primary completion date

Apr 15, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Exposed cohort

1. Currently or recently (within 1 year of pregnancy outcome) pregnant
2. Diagnosis of moderate/severe SLE
3. Consent to participate
4. Authorization for their HCP(s) to provide data to the registry
5. Exposure to at least 1 dose of anifrolumab at any time during pregnancy

Unexposed cohort

1. Currently or recently pregnant
2. Diagnosis of moderate/severe SLE
3. Consent to participate
4. Authorization for their HCP(s) to provide data to the registry
5. Exposure to other products for the treatment of moderate/severe SLE

Exclusion Criteria:

Exposed cohort

1. Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled)
2. Exposure to known teratogens and/or investigational medications during pregnancy

Unexposed cohort

1. Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled)
2. Exposure to known teratogens and/or investigational medications during pregnancy

Study Design

Enrollment

442 participants

Anticipated

Interventions and Outcome Measures

Arms

Exposed cohort

Pregnant individuals with a diagnosis of moderate/severe SLE who are exposed to anifrolumab at any time during pregnancy

Unexposed cohort

Pregnant individuals with a diagnosis of moderate/severe SLE who are not exposed to anifrolumab at any time during pregnancy but who are exposed to other products for the treatment of SLE

Interventions

Anifrolumab

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. 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. 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. Anifrolumab was approved by the FDA and EMA in July 2021 and February 2022, respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.

Primary outcome measure

  • Composite outcome of all major congenital malformations (MCMs) [ Time Frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Wilmington, North Carolina, United States, 28401

More Information

Sponsor

AstraZeneca

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Chronic autoimmune disease
  • Immunosuppressants
  • Corticosteroids
  • Human monoclonal antibody (IgG1ƙ mAb)
  • Post Marketing Requirements (PMR) study
  • Pregnancy
  • Systemic Lupus Erythematosus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-02.