Lupus drug anifrolumab under scrutiny in pregnancy safety study

NCT ID NCT06659029

Recruiting now Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 442 pregnant women with moderate-to-severe lupus to see if taking the drug anifrolumab (Saphnelo) during pregnancy affects the health of mothers or their babies. Researchers will compare women who took the drug during pregnancy to those who did not, tracking birth defects and other outcomes. The goal is to gather real-world safety data to guide future use.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: anifrolumab (Saphnelo)
What this could lead to: If this study finds no increased risks, it could help doctors and patients make safer decisions about using anifrolumab during pregnancy.
What could go wrong: This is an observational registry, not a controlled trial, so it can only show associations, not cause and effect. Results may take years and could be inconclusive.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SYSTEMIC LUPUS ERYTHEMATOSUS

Contacts and locations

Locations

Research Site
RECRUITING

Wilmington, North Carolina, 28401, United States

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