Avacopan in patients with Vasculitis
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine
IRAS ID
220827
Contact name
David Jayne
Contact email
Sponsor organisation
ChemoCentryx, Inc.
Eudract number
2016-001121-14
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
CCX168 (also called avacopan) is an investigational medicinal product being developed by ChemoCentryx Inc., and studied for the treatment of vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). AAV includes conditions also known as granulomatosis with polyangiitis (GPA, formerly called Wegener’s disease) and microscopic polyangiitis (MPA).
AAV standard therapy includes cyclophosphamide (IV or oral, although IV is preferred because of a lower cumulative dose and lower toxicity), and prednisone. Prednisone is a so-called glucocorticoid or corticosteroid and as such has several side effects. Therefore, the medical need for alternative therapies remains high and to find ways to reduce or eliminate corticosteroid use in the treatment of AAV.
The rationale for this phase 3 study is to test how well CCX168 works when it replaces oral prednisone in the above mentioned standard treatments of patients with AAV. The study will evaluate the effectiveness of CCX168 in inducing and sustaining disease remission in patients with AAV in comparison to prednisone in patients who are also on a background of either cyclophosphamide/azathioprine or rituximab treatment. This study will also assess how safe CCX168 is and evaluate overall disease activity, renal function (if the patient has renal disease involvement), and health-related quality of life.
CCX168 has been evaluated previously in 102 healthy adult subjects and additionally in 109 adult patients with ANCA-associated vasculitis who have already completed two clinical studies. Overall, no clinically significant changes in laboratory parameters, vital signs or ECG were observed and seems to be well tolerated.
The study will be done at approximately 200 study centres globally. Up to approximately 300 patients, at least 12 years of age will be in the study.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
17/EE/0079
Date of REC Opinion
6 Apr 2017
REC opinion
Further Information Favourable Opinion