A randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety and efficacy of CCX168 in subjects with renal vasculitis on background cyclophosphamide treatment

ChemoCentryx, Inc. (USA)0 sites60 target enrollmentAugust 25, 2011

Overview

Registry

who.int

Start Date

August 25, 2011

End Date

March 31, 2013

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

ChemoCentryx, Inc. (USA)

•1\. Clinical diagnosis of Wegener?s granulomatosis, microscopic polyangiitis or renal limited vasculitis
•2\. Male and postmenopausal or surgically sterile female subjects, aged 18\-75 years with new or relapsed ANCA\-associated renal vasculitis (AARV) where treatment with cyclophosphamide would be required
•3\. Positive indirect immunofluorescence (IIF) test for peri\-nuclear (protoplasmic\-staining) antineutrophil cytoplasmic antibodies (P\-ANCA) or C\-ANCA, or positive Enzyme\-linked immunosorbent assay (ELISA) test for anti\-proteinase\-3 (PR3\) or anti\-myeloperoxidase (MPO) at screening
•4\. Proven to have renal vasculitis based on renal biopsy or have hematuria and proteinuria compatible with nephritis
•5\. Estimated glomerular filtration rate of greater than 30 mL per minute

•1\. Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage, hemoptysis, rapid\-onset mononeuritis multiplex or central nervous system involvement
•2\. Any other multi\-system autoimmune disease
•3\. Medical history of coagulopathy or bleeding disorder
•4\. Received cyclophosphamide within 12 weeks of screening; if on azathioprine, mycophenolate mofetil, or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide dose on Day 1
•5\. Received high\-dose intravenous corticosteroids within 4 weeks of screening
•6\. On an oral dose of a corticosteroid of more than 10 mg prednisone\-equivalent at the time of screening
•7\. Received rituximab or other B\-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred; received anti\-TNF treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), or plasma exchange within 12 weeks of screening