Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Primary Antiphospholipid Syndrome
• Age: Between 18 Year(s) - 56 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. The completion of the following vaccinations at least 14 days prior to Visit 0:
     • COVID-19 primary vaccination series according to FDA authorization and the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), and defined as either:
       • Two doses of a Pfizer-BioNTech or Moderna mRNA COVID-19 vaccine, or
       • One dose of the Janssen COVID-19 vaccine, or
       • A primary vaccination series with any other FDA approved or authorized COVID-19 vaccine, and
     • COVID-19 booster immunization(s), according to the CDC ACIP, and
     • At least one dose of the herpes zoster vaccination series, and
     • Current seasonal influenza vaccine, if available.
  2. History of APS

  
  

You may not be eligible for this study if the following are true:

• 1. Inability or unwillingness to give written informed consent.
  2. Inability or unwillingness to comply with study protocol.
  3. Systemic autoimmune diseases other than APS.
  4. Catastrophic APS classification within the prior 90 days.
  5. Acute arterial or venous thrombosis within the prior 30 days.
  6. Unwilling or unable to undergo anticoagulation with warfarin or low molecular weight heparin (LMWH), if there is a history of arterial or venous thrombosis.
  7. Plasma exchange within the prior 90 days.
  8. Hemodialysis within the prior 90 days.
  9. Major surgical procedure within the prior 60 days.
  10. Known allergy, hypersensitivity, or intolerance to boron, malitol, sorbitol, corticosteroids, monoclonal antibodies including daratumumab, human proteins, or their excipients.
  11. Allergy, intolerance, or contraindication to acyclovir, valacyclovir, and famciclovir.
  12. History of primary immunodeficiency.
  13. History of solid organ or hematopoietic stem cell transplantation.
  14. Comorbidities requiring systemic corticosteroid therapy, including those which have required three or more courses of systemic corticosteroids within the 12 months prior to Visit 0.
  15. Pulmonary hypertension.
  16. Poorly controlled diabetes.
  17. Concomitant malignancy or history of malignancy, except adequately treated or excised nonmetastatic squamous cell carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
  18. Clinically significant cardiac disease.
  19. Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease.
  20. Pregnancy, or planning a pregnancy during the 48 week study duration.
  21. Breast-feeding.
  22. Unwillingness to use medically acceptable non-prothrombotic contraception if of reproductive potential and engaging in sexual activity that could lead to pregnancy.