MO039SUCCESSFUL STEROID REPLACEMENT IN ANCA-ASSOCIATED VASCULITIS WITH C5A RECEPTOR INHIBITOR CCX168 IN PHASE 2 RANDOMISED TRIAL (CLEAR)

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Introduction and Aims: To investigate the potential of the orally administered complement 5a receptor inhibitor CCX168 to substantially or completely replace steroids while maintaining or improving efficacy in patients with active ANCA-associated vasculitis (AAV) receiving cyclophosphamide (CYC) or rituximab (RTX). Methods: This randomised, double-blind, placebo-controlled Phase 2 trial (CLEAR) in 11 European countries included 3 groups: (1) High dose steroids standard of care (SOC) control: Placebo + CYC or RTX + 60 mg starting dose of prednisone, (2) CCX168 30 mg b.i.d. + CYC or RTX + 20 mg starting dose of prednisone, or (3) CCX168 30 mg b.i.d. + CYC or RTX + no prednisone. The CYC regimen was 15 mg/kg IV q2 to 4 weeks. The RTX regimen was 375 mg/m2 IV weekly for 4 weeks. The primary endpoint compared each CCX168 group to SOC control, based on Birmingham Vasculitis Activity Score (BVAS) response, defined as BVAS decrease from baseline of ≥50% and no worsening in any body system. Eligible patients had GPA, MPA, or renal limited vasculitis and PR3 or MPO-ANCA positivity.

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