Lupus Trial, Recruiting NCT07049653 Sponsor: AstraZeneca Condition: Lupus
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Lupus Trial, Recruiting

NCT07049653
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a woman who has been continuously registered in the health database for at least 12 months before the start of your most recent pregnancy
  • You were diagnosed with lupus (SLE) before becoming pregnant
  • You have moderate or severe lupus (SLE)
  • For the exposed group: You received the medication anifrolumab (alongside standard lupus treatment) during pregnancy and/or in the 16 weeks before your pregnancy began
  • For the unexposed/comparison group: You received standard lupus treatment during pregnancy, but did not take anifrolumab

Who may not be able to join:

  • Women whose conception date cannot be reliably determined from records
  • Women who have a history of certain birth defects in previous pregnancies or chromosomal abnormalities in their baby (based on available medical records), recorded before delivery
  • Women who were prescribed a medication known to cause birth defects, either during pregnancy or within a specific timeframe before pregnancy began (confirm with trial site for details on which medications and timeframes apply)
  • For the comparison group only: Women who received anifrolumab during pregnancy or in the 16 weeks before pregnancy began

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 1-877-240-9479

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
4 June 2026
Est. completion
10 December 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Risk of major congenital malformations (MCM); Relative risk of MCM; Risk of select pregnancy loss outcomes; Relative risk of select pregnancy loss outcomes

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov