Status:
NOT_YET_RECRUITING
A Study to Evaluate Crovalimab in People With Antiphospholipid Syndrome (APS)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Antiphospholipid Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to evaluate the efficacy of crovalimab compared with placebo as an add-on therapy to vitamin K antagonist (VKA) in participants with APS.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
- 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
- Inadequate renal and hepatic function
- 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
Key Trial Info
Start Date :
March 16 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 2 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07172022
Start Date
March 16 2026
End Date
December 2 2030
Last Update
January 9 2026
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