A Study to Evaluate Crovalimab in People With Antiphospholipid Syndrome (APS)

Ki vehet részt

• Age ≥18 years and ≤70 years, and body weight ≥40 kilograms (kg), at the time of signing Informed Consent Form
• Vaccination against N. meningitidis, H. influenzae type B, and S. pneumoniae
• Participants classified with APS who have experienced at least two prior arterial and/or venous thrombotic events, based on the 2023 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) criteria, positive for at least two of the following: lupus anticoagulant (LAC) test, anticardiolipin antibodies (aCL), anti-β2-glycoprotein 1 antibodies (aβ2GP1)
• Participants receiving corticosteroids, antimalarial treatment, non-biologic disease-modifying rheumatic drugs, statins, and low dose aspirin must be on a stable dose prior to the first dose of study treatment
• Willingness and ability to comply with a VKA regimen titrated to a therapeutic target internal normalized ratio (INR)
• Agreement to adhere to the contraception requirements

Ki nem vehet részt

• Treatment with investigational therapy, complement inhibitor, and/or other immune-suppressive biologic therapy within 5 half-lives of that agent prior to screening visit, or plans to participate in another investigational trial
• Presence of another systemic autoimmune disease that is unstable and requires additional treatment, and constitutes the principal illness and may impact evaluation of the concurrent APS
• Uncontrolled hyperlipidemia and/or hypertension, known diabetes mellitus, and/or serious infection requiring hospitalization or antibiotics prior to Week 1 Day 1
• History or condition associated with increased bleeding risk
• Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
• Inadequate renal and hepatic function