Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial)
A Phase II Open-Label Pilot Trial Assessing the Safety of Anifrolumab in Adult Patients With Primary Antiphospholipid Syndrome (APS). The AnifAPS Trial
National and Kapodistrian University of Athens
20 participants
Apr 29, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Anifrolumab 120 mg administered subcutaneously once weekly for up to 52 weeks in addition to standard of care treatment.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07584083