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Positive Results Announced in Phase 2 CLEAR Trial of CCX168 for ANCA-associated Vasculitis
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ChemoCentryx Inc. announced use of orally administered complement 5a receptor inhibitor CCX168 in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis yielded positive results compared with the standard care of high-dose chronic steroids.
Designed to assess whether high-dose chronic steroids, such as prednisone or methylprednisone, currently used in the anti-neutrophil cytoplasmic antibody-association vasculitis (AAV) standard of care could be replaced with CCX168 without compromising efficacy, the phase II trial showed 86% of patients receiving CCX168 plus low dose steroids and 81% of patients receiving CCX168 plus no steroids had a numerically superior and statistically noninferior Birmingham Vasculitis Activity Scores at 12 weeks vs. 70% of patients in the standard care group of high dose steroids. According to a company press release, researchers also found early clinical remission at 4 weeks sustained through 12 weeks in a higher proportion of patients receiving CCX168.
According to results, after 4 weeks of treatment, albuminuria decreased by 47% in patients treated with CCX168 without any steroids and by 40% in patients treated with CCX168 plus low dose steroids, but increased by 15% among patients in the standard of care group. Compared to the standard of care group, patients receiving CCX168 experienced significant improvement in physical function, mental health, emotional well-being, pain and vitality, and as less cumulative organ damage, results showed. However, researchers noted estimated glomerular filtration rate and hematuria improved similarly in the CCX168 group and standard of care group.
“The data from the CLEAR trial suggest that CCX168 has a rapid onset of action and could potentially replace chronic steroids currently used in the treatment of AAV with the same or better efficacy,” the principal investigator of the study Dr. David Jayne, director of the Vasculitis and Lupus Clinic, the University of Cambridge, United Kingdom, said in the release. “Given the high incidence of morbidity and mortality associated with high-dose chronic steroids in this disease setting, CCX168 may offer an important and safer therapeutic option, minimizing or eliminating the use of steroids while potentially improving long-term kidney outcomes in patients with AAV.” – by Casey Tingle
References:
Jayne D, et al. Paper #MO039. Presented at: European Renal – European Dialysis and Transplant Association Congress; May 21-24, 2016; Vienna.
Disclosure: Jayne is on the board of Aurinia; is a consultant for Roche/Genentech, GSK and ChemoCentryx; provided expert/scientific advice to Biogen and ChemoCentryx; and is a member of IWG and European Vasculitis Society.