Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial)

This is a phase II, single-centre, open-label pilot study evaluating the safety and tolerability of anifrolumab in adult patients with primary antiphospholipid syndrome (APS). Approximately 20 participants will receive 120 mg subcutaneous anifrolumab once weekly for up to 52 weeks in addition to their standard of care treatment. The primary objective is to assess the incidence of adverse events during treatment. Secondary and exploratory objectives include evaluation of immunological parameters, thromboinflammatory markers, and patient-reported outcomes. Participants will be followed for an additional 12-week safety follow-up period after completion of treatment.

NCT Number	NCT07584083
Lead Sponsor	National and Kapodistrian University of Athens Collaborators: AstraZeneca
Conditions	Antiphospholipid Syndrome (APS)
Enrollment	20 participants
Start Date	2026-04-29
Primary Completion	2028-06 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-02