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Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial)

NCT07584083 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Antiphospholipid Syndrome (APS)

Interventions

DRUG

Anifrolumab

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • National and Kapodistrian University of Athens

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-24
Primary Completion
2028-06-30
Completion
2028-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584083 on ClinicalTrials.gov