Actively Recruiting
A Phase II Open-Label Pilot Trial Assessing the Safety of Anifrolumab in Adults With Primary Antiphospholipid Syndrome (APS)
Led by National and Kapodistrian University of Athens · Updated on 2026-06-02
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National and Kapodistrian University of Athens
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of anifrolumab in adults with primary antiphospholipid syndrome (APS) in this phase II, single-center, open-label pilot study. About 20 participants with APS will be treated to understand the incidence of adverse events and explore effects on immune and thromboinflammatory markers, as well as patient-reported outcomes. The study is led by the National and Kapodistrian University of Athens and focuses on patients meeting specific APS classification criteria without obstetric manifestations. Participants will receive 120 mg of anifrolumab by subcutaneous injection once a week for up to 52 weeks, alongside their standard care treatment for APS. After finishing the treatment period, they will enter a 12-week safety follow-up phase to monitor any lasting effects or adverse events. This approach aims to assess the safety profile of anifrolumab when added to usual APS care. Throughout the study, participants will undergo various assessments including laboratory tests to measure immunological and thromboinflammatory markers, evaluations of health-related quality of life, and physician health status assessments at multiple time points. Safety will be closely monitored during treatment and the follow-up period. Participants are expected to complete all visits and tests over approximately 64 weeks, covering treatment and safety observation phases.
CONDITIONS
Brief Title
Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Be male or female aged 18 to 70 years at screening
- Weigh at least 40.0 kg at screening
- Meet 2023 ACR/EULAR criteria for primary APS with at least one clinical and one laboratory criterion and scoring at least three points in each domain
- Females of childbearing potential must have a negative pregnancy test at screening
- Females of childbearing potential must use a highly effective contraception method throughout the study and for 20 weeks after last dose
- Male patients sexually active with females of childbearing potential must use condoms with spermicide during the study and for 20 weeks after last dose
- Male patients must not donate sperm during the study and for 20 weeks after last dose
- Meet tuberculosis screening criteria including no active or untreated latent TB and negative or managed QuantiFERON-TB Gold test
- Chest x-ray or lung CT within 12 weeks prior to consent showing no active infection or significant abnormalities
- Negative SARS-CoV-2 test as per local policy at screening
- Females with an intact cervix must have a normal Pap smear within 2 years prior to baseline
You will not qualify if you...
- Any condition that might interfere with study safety or evaluation
- Involvement in study planning or conduct
- Participation in another clinical trial with an investigational product
- Pregnant, lactating, or intending pregnancy during the study
- Current or recent alcohol, drug, or chemical abuse
- Major surgery within 8 weeks prior to screening or planned during the study
- Pregnancy-related events within 4 weeks prior to screening
- Certain abnormal laboratory values at screening including liver enzymes, bilirubin, creatinine, blood counts, and HbA1c for diabetics
- Diagnosis of systemic lupus erythematosus or other systemic autoimmune diseases
- History or diagnosis of catastrophic APS within 12 months prior to screening
- Severe or unstable neuropsychiatric APS or major psychiatric conditions
- Moderate to severe depression or recent suicidal behavior
- History of primary immunodeficiency, splenectomy, or HIV infection
- Positive hepatitis B or C serology or active infection
- Severe herpes zoster or unresolved viral infections
- History of severe COVID-19 or recent COVID-19 infection with complications
- Opportunistic infections requiring hospitalization or IV antibiotics within 3 years
- Recent serious or chronic infections
- History of malignancy except certain skin or cervical cancers
- Current treatment with direct oral anticoagulants
- Prior treatment with anifrolumab or certain biologic, immunosuppressive, or corticosteroid therapies within specified timeframes
- Blood transfusion within 4 weeks prior to screening
- Allergy to study drug components or history of anaphylaxis to gamma globulin therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive 120 mg subcutaneous anifrolumab once weekly for up to 52 weeks in addition to their ongoing standard of care treatment for primary antiphospholipid syndrome.
Weekly visits for up to 52 weeks
Duration - 12 weeks
Participants are monitored for safety during a 12-week period after completing treatment.
Approximately 3 monthly visits
Trial Site Locations
Total: 1 location
1
Laiko General Hospital
Athens, Greece, Greece, 11524
Actively Recruiting
Research Team
M
Maria G Tektonidou, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here