Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial)

Recruiting now · Phase 2

Conditions studied: Antiphospholipid Syndrome (APS)

In brief

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.

Key facts

Study ID

NCT07584083

Run by

National and Kapodistrian University of Athens

People needed

20

Starts

2026-04-29

Expected to finish

2028-06-01

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of written informed consent (ICF) prior to any study-specific procedures.
• Females/males aged 18 to 70 years at Screening (at the time of ICF signing).
• Weight ≥40.0 kg at Screening.
• Classified as having primary APS as per the 2023 ACR/EULAR APS classification criteria, i.e. fulfilling at least one documented clinical criterion [ie., macrovascular (venous thromboembolism and/or arterial thrombosis), established microvascular (livedoid vasculopathy, aPL nephropathy, pulmonary haemorrhage or myocardial disease), cardiac valve (valve thickening or valve vegetation) and/or haematology (thrombocytopenia)] and at least one laboratory criterion and scoring at least three points in each of the clinical and laboratory domains.
• Note: Patients with obstetric manifestations will be excluded from this study.
• For females of childbearing potential only: Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at Screening.
• Females of childbearing potential must be willing to use a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) throughout their participation in the study, i.e., from Screening and for up to 20 weeks after the last dose of IP. Examples of highly effective methods of contraception are located in Appendix C, Contraceptive and Barrier Guidance.
• Male patients who are sexually active with a female partner of childbearing potential must be willing to use a condom (with spermicide where commercially available) throughout their participation in the study, i.e., from Screening and for up to 20 weeks after the last dose of IP.
• Male patients must not donate sperm during the course of the study and for up to 20 weeks after the last dose of the IP.
• Meeting all the following TB criteria:
• No history of latent or active TB prior to Screening, except for latent TB with documented completion of appropriate treatment as per local SoC Note: Subjects with no history of latent TB prior to the initial Screening visit, but who are diagnosed with latent TB during the Screening Period, may be considered eligible if appropriate treatment is initiated prior to first administration of IP as per local SoC. Such subjects may be re-screened if necessary to allow for local guidelines on latent TB treatment initiation.
• No signs or symptoms suggestive of active TB from medical history or physical examination
• No recent contact with a person with active TB OR if there has been such contact, referral to a physician specialising in TB to undergo additional evaluation prior to first administration of IP (documented appropriately in source), and, if warranted, receipt of appropriate treatment for latent TB at or prior to first administration of IP as per local SoC.
• Must meet 1 of the following criteria:
• (i)Negative QuantiFERON-TB Gold (QFT-G) test result for TB obtained within 4 weeks prior to Week 0 (Day 1) OR (ii)Positive QFT-G test result for TB obtained during the Screening Period for which active TB has been ruled out and appropriate treatment for latent TB has been initiated prior to first administration of IP as per local SoC OR (iii)Indeterminate (confirmed on retest) QFT-G test result for TB obtained during the Screening Period with ongoing QFT-G testing for TB as clinically indicated.
• Chest x-ray [or lung CT*, where available] with no evidence of current active infection (eg, TB) or previous old active TB, malignancy, or clinically significant abnormalities (unless due to APS) obtained during the Screening Period or anytime within 12 weeks prior to signing the ICF.
• Negative SARs-CoV-2 polymerase chain reaction (PCR) or antigen test result as per local policies at Screening.
• Females with an intact cervix must have documentation of a normal Pap smear with no documented malignancy (e.g., cervical intraepithelial neoplasia grade III [CIN III], carcinoma in situ [CIS], or adenocarcinoma in situ [AIS]) within 2 years prior to Week 0 (Day 1) (see Appendix E for guidance on abnormal Pap smear results).
• Note: Any abnormal Pap smear result documented within 2 years prior to randomisation must be repeated to confirm patient eligibility. See also Exclusion criterion 23b.

You may not qualify if…

• General exclusion criteria:
• Any condition that, in the opinion of the Investigator, would interfere with the efficacy or safety evaluation of the study intervention or put the participant at safety risk.
• Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
• Current participation in another clinical study with an IP.
• Lactating or pregnant females or females who intend to become pregnant anytime from initiation of Screening through the Safety Follow-up Period (12 weeks following last dose of IP).
• Current alcohol, drug or chemical abuse, or a history of such abuse within 12 months prior to Week 0 (Day 1).
• Major surgery within 8 weeks prior to Screening or elective major surgery planned anytime from initiation of Screening through the Safety Follow-up Period (12 weeks following last dose of IP).
• Spontaneous or induced abortion, still or live birth, or pregnancy ≤4 weeks prior to Screening.
• Any of the following laboratory abnormalities at Screening (within 4 weeks prior to Week 0 [Day 1]):
• aspartate aminotransferase (AST) >2.5 x upper limit of normal (ULN)
• alanine aminotransferase (ALT) >2.0 x ULN
• total bilirubin > ULN (unless due to Gilbert's syndrome)
• serum creatinine >2.5 mg/dL (or >181 μmol/L)
• urine protein/creatinine ratio (UACR) >2.0 mg/mg (or >226.30 mg/mmol)
• neutrophil count <1000/μL (or <1.0 x 109/L)
• PLT <25000/ μL (or <25 x 109/L)
• haemoglobin <8 g/dL (or <80 g/L)
• glycosylated haemoglobin (HbA1c) >8% (or >0.08) for diabetic subjects only Note: Abnormal screening laboratory tests may be repeated once on a separate sample before the subject is declared a screen failure.
• Major surgery within 8 weeks prior to Screening or elective major surgery planned anytime from initiation of Screening through the Safety Follow-up Period (12 weeks following last dose of IP).
• Exclusion criteria related to APS and/or other medical conditions/diseases:
• Meeting ACR/EULAR classification criteria for SLE or other systemic autoimmune diseases.
• History or current diagnosis of catastrophic APS within 12 months prior to Screening.
• Any medical or psychiatric condition (including severe or unstable neuropsychiatric APS) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
• Current evidence of moderately severe depression as indicated by a score ≥15 in the PHQ-9 questionnaire at Screening.
• Known history of suicidal behaviour in the past 12 months prior to Screening or current evidence of suicidal ideation as indicated by a positive response (i.e., selecting 1: "Several days", 2: "More than half the days" or 3: "Nearly every day") to Question 9 of the PHQ-9 questionnaire irrespective of total score at Screening.

Where it is running

• Laiko General Hospital — Athens, Greece, Greece (enrolling)

Full record on ClinicalTrials.gov

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