BridgeMD
New treatment option for Antiphospholipid Syndrome (APS)
Official title Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial)
ClinicalTrials.gov ID: NCT07584083
What this study is testing
What is Anifrolumab?
Anifrolumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for antiphospholipid syndrome (aps).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 52 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
- For females of childbearing potential only: Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at Screening.
You likely can't join if
- General exclusion criteria:
- Any condition that, in the opinion of the Investigator, would interfere with the how well it works or safety evaluation of the study intervention or...
- 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...
- Current alcohol, drug or chemical abuse, or a history of such abuse within 12 months prior to Week 0 (Day 1).
See the full eligibility criteria
Who can join
- 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)...
- 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...
- 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...
- 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: people with no history of latent TB prior to the initial Screening...
- 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...
- 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...
- 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...
- 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...
What rules you out
- General exclusion criteria:
- Any condition that, in the opinion of the Investigator, would interfere with the how well it works 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 people 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...
- 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...
- 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"...
- Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection or a positive result for humanimmunodeficiency virus (HIV) antibody or infection confirmed...
- Confirmed seropositivity for hepatitis B at Screening, i.e.:
- Positive result for hepatitis B surface antigen (HBsAg), OR
- Positive result for hepatitis B core antibody (HBcAb) AND hepatitis B virus (HBV) DNA detected above the lower limit of quantification (LLQ) by reflex testing by the local laboratory. Note: Patients who are...
- Positive result for hepatitis C antibody at Screening.
- Any severe herpes zoster infection at any time prior to Week 0 (Day 1), including but not limited to, non-cutaneous herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2...
- Any herpes zoster, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to Screening.
- Any history of severe COVID-19 infection or any prior COVID-19 infection with documented long-COVID and/or clinically significant unresolved sequelae within 12 months prior to Week 0 (Day 1) or mild/asymptomatic acute...
- Any opportunistic infection requiring hospitalisation or treatment with IV antibiotics within 3 years prior to Screening.
- Any of the following:
- Clinically significant chronic infection (e.g. osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to Week 0 (Day 1) (chronic nail infections are allowed)
- Any infection requiring hospitalization or treatment with IV antibiotics not completed at least 4 weeks prior to Week 0 (Day 1)
- Any infection requiring oral antibiotics (including antivirals) within 2 weeks prior to Week 0 (Day 1).
- History of malignancy except for:
- squamous or basal cell carcinoma of the skin with documented success of curative therapy of ≥3 months prior to Week 0 (Day 1), OR
- cervical cancer in situ (CIS) treated with documented success of curative therapy ≥12 months prior to Week 0 (Day 1) Exclusion criteria related to prior/concomitant medications:
- Currently receiving direct oral anticoagulants (DOACs).
- Prior treatment with any of the following:
- anifrolumab
- any investigational product (small molecule or biologic agent) within 90 days or 5 half-lives prior to Screening, whichever is greater
- any commercially available biologic agent, including but not limited to B-cell depleting therapies [i.e. rituximab, other anti-CD20, anti-CD22 or anti-CD38 agents], anti-TNF-α agents, belimumab, abatacept or any other...
- any commercially available protein kinase inhibitor including but not limited to Janus kinase (JAK) inhibitors or Bruton's tyrosine kinase (BTK) inhibitors within 90 days or 5 half-lives prior to Screening, whichever is...
- conventional immunomodulators or immunosuppressants (e.g., cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, etc.) or IV immunoglobulin within 90 days prior to Screening
- intraarticular, intramuscular, or intravenous corticosteroids within 30 days prior to Screening.
- any live or attenuated vaccine within 8 weeks prior to Screening.
- Current treatment with oral corticosteroids except for patients with severe thrombocytopenia or pulmonary haemorrhage who have started oral corticosteroids (up to 40 mg/day prednisone or equivalent) within 30 days Week...
- Blood transfusion or receipt of blood products within 4 weeks prior to Screening.
- Known history of allergy or reaction to any component of the IP formulation or history of anaphylaxis to any human gamma globulin therapy. For procedures for withdrawal of incorrectly enrolled people, see Section 3.4.
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Greece, Greece
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Greece, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.