The Anifrolumab PRIM Program

Recruiting now · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program

Key facts

Study ID

NCT06795893

Run by

AstraZeneca

People needed

240

Starts

2025-11-07

Expected to finish

2031-04-15

Last updated by the study team

2026-07-08

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Currently or recently (within 1 year of pregnancy outcome) pregnant
• Exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception

You may not qualify if…

• Pregnancy cases that have been enrolled in the prospective pregnancy registry (D3461R00051), those reported prior to the start of the PRIM program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab PRIM study.

Where it is running

• Reseach Facility — Södertälje, Sweden (enrolling)

Full record on ClinicalTrials.gov

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