Study of anifrolumab safety in adults with primary antiphospholipid syndrome (APS)

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What is this study about?

This study focuses on patients with Primary Antiphospholipid Syndrome (APS), an autoimmune disorder that causes blood clots to form in blood vessels. The research evaluates a medication called anifrolumab (also known as MEDI-546), which is given as a solution for injection under the skin (subcutaneous injection).

The purpose of this research is to assess the safety and how well patients tolerate anifrolumab when used to treat APS. The study is designed as an open-label trial, which means all participants will receive the active medication. The treatment period lasts for 52 weeks, during which participants will receive regular doses of anifrolumab through subcutaneous injections.

Throughout the study, doctors will monitor participants for any side effects, with special attention to certain medical conditions such as infections, shingles (herpes zoster), influenza, and allergic reactions (anaphylaxis). They will also track various health measurements including blood tests to check for specific antibodies and proteins that are important in APS, as well as assess how the treatment affects participants’ quality of life and daily activities.

1 Initial medical assessment

A chest x-ray or lung CT scan will be performed to check for any infections or abnormalities

A SARs-CoV-2 test (COVID-19) will be conducted

Female patients will need to provide documentation of a normal Pap smear from the past 2 years

Basic health measurements including weight check (must be at least 40 kg)

Pregnancy test for females who can become pregnant

2 Treatment phase begins

Anifrolumab will be administered through subcutaneous injection (under the skin)

Regular monitoring for side effects and health changes will begin

Treatment continues for 52 weeks (1 year)

3 Regular health assessments

Health checks at weeks 4, 12, 24, 36, 48, and 52

Blood tests to monitor various health markers

Assessment of quality of life using standard questionnaires

Physical examinations to check for any changes in symptoms

4 Safety monitoring

Continuous monitoring for side effects, particularly:

Infections

Herpes zoster (shingles)

Influenza (flu)

Any allergic reactions

5 Final assessment

Complete evaluation of health status at week 52

Final blood tests and physical examination

Assessment of treatment effectiveness

Review of any side effects experienced during the study

Who Can Join the Study?

Must provide written informed consent before any study procedures begin
Must be between 18 and 70 years old at screening
Must weigh at least 40.0 kg at screening
Must have a chest X-ray or lung CT scan showing no active infections, tuberculosis, cancer, or significant abnormalities within 12 weeks before enrollment
Must test negative for SARS-CoV-2 (COVID-19) at screening
Must be diagnosed with primary Antiphospholipid Syndrome (APS) according to specific medical criteria, excluding pregnancy-related cases
Female participants with a cervix must have had a normal Pap smear within 2 years before the study start
Women who can become pregnant must:
- Have a negative pregnancy test at screening
- Agree to use highly effective birth control throughout the study and for 20 weeks after
Male participants must:
- Use condoms during the study and for 20 weeks after if sexually active with women who can become pregnant
- Not donate sperm during the study and for 20 weeks after
Regarding tuberculosis (TB), participants must:
- Have no history of active TB
- Show no current TB symptoms
- Have negative or appropriately treated TB test results

Who Cannot Join the Study?

Current or history of any blood clotting disorders other than Primary Antiphospholipid Syndrome
Known allergic reactions to Anifrolumab or similar medications
Current pregnancy or breastfeeding
Active or chronic infections, including hepatitis B, hepatitis C, HIV, or tuberculosis
History of cancer within the past 5 years (except for successfully treated skin cancer)
Severe kidney or liver disease
Major surgery within 8 weeks before starting the study
Participation in another clinical trial within the past 30 days
Substance abuse or alcohol dependency within the past 6 months
Mental health conditions that could interfere with study participation
Use of prohibited medications, including immunosuppressive drugs (medicines that lower the body’s ability to fight infections)
Severe, uncontrolled high blood pressure or heart disease
Any condition that, in the opinion of the study doctor, makes participation unsafe

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Lifoh Gebhbpu Hnwfoppv Oz Awjeqo	Athens	Greece

Trial status

Country	Status	Recruitment Start
Greece	Recruiting	01.02.2026

Trial locations

Investigated drugs:

Anifrolumab

Anifrolumab is a medication that works by blocking a protein called type I interferon receptor. It is designed to reduce inflammation in the body. This medication is currently being studied for treating Primary Antiphospholipid Syndrome (APS), an autoimmune disorder where the body’s immune system mistakenly creates antibodies that make the blood more likely to clot. The medication is given through an intravenous infusion (through a vein).

Primary Antiphospholipid Syndrome (APS) – An autoimmune disorder where the body’s immune system mistakenly produces antibodies that attack certain proteins in the blood. These antibodies can cause blood to clot more easily than normal in both arteries and veins. The condition can affect various organs and tissues in the body, leading to complications such as blood clots in the legs, lungs, or other parts of the body. The disease can also affect pregnant women, causing pregnancy complications. Some patients may develop skin changes, including a lace-like purple rash or skin ulcers.

Trial ID:

2025-520918-64-00

Protocol code:

D3461C00035

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of anifrolumab safety in adults with primary antiphospholipid syndrome (APS)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?