Recruiting

Anifrolumab

Sponsor:

AstraZeneca

Code:

NCT07049653

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT07049653

Start date

Jun 4, 2026

Status verified date

Aug, 2026

Completion date

Dec 10, 2030

Anticipated

Primary completion date

Dec 10, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion criteria for EXPOSED SOURCE POPULATION:

  • Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
  • Women diagnosed with SLE before pregnancy
  • Women exposed to anifrolumab (polytherapy, added to SLE SOC) during pregnancy and/or 16-week period prior to LMP2

Exclusion criteria for EXPOSED SOURCE POPULATION:

\- Pregnancies whose date of conception cannot be established

Inclusion criteria for UNEXPOSED SOURCE POPULATION:

  • Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
  • Women diagnosed with SLE before pregnancy
  • Women treated with SLE SOC during pregnancy

Exclusion criteria for UNEXPOSED SOURCE POPULATION:

  • Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2
  • Pregnancies whose date of conception cannot be established

Inclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:

\- Women with moderate/severe SLE

Exclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:

  • Women with a history of CM or chromosomal abnormalities (according to available records), before delivery
  • Women prescribed a confirmed teratogenic drug prior to LMP2 with a time period of 5-half-lives of relevant drug or during pregnancy

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Exposed cohort

Pregnant individuals with a diagnosis of 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

Primary outcome measure

  • Risk of major congenital malformations (MCM) [ Time Frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births ]
  • Relative risk of MCM [ Time Frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births ]
  • Risk of select pregnancy loss outcomes [ Time Frame: At delivery/birth ]
  • Relative risk of select pregnancy loss outcomes [ Time Frame: At delivery/birth ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Cary, North Carolina, United States, 27513

More Information

Sponsor

AstraZeneca

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • pregnancy, anifrolumab, SLE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-19.