RecruitingPhase 2NCT07584083

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


Sponsor

National and Kapodistrian University of Athens

Enrollment

20 participants

Start Date

Apr 29, 2026

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Anifrolumab for people with antiphospholipid syndrome (aps). The study is currently recruiting participants at 1 location.

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

DRUGAnifrolumab

Anifrolumab 120 mg administered subcutaneously once weekly for up to 52 weeks in addition to standard of care treatment.


Locations(1)

Laiko General Hospital

Athens, Greece, Greece

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NCT07584083


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