A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis
The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement C5a receptor plus cyclophosphamide or rituximab.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background of Cyclophosphamide or Rituximab Treatment|
- Safety of CCX168 in subjects with AAV [ Time Frame: 169 days ] [ Designated as safety issue: Yes ]Safety assessments include adverse events, physical examination abnormalities, vital signs and clinical laboratory tests (including blood chemistry, hematology and urinalysis).
- Efficacy of CCX168 in subjects with AAV [ Time Frame: 169 days ] [ Designated as safety issue: No ]Efficacy will be assessed by BVAS (a global disease activity index).
- Systemic corticosteroid use [ Time Frame: 169 days ] [ Designated as safety issue: No ]Systemic corticosteroid use based on total oral corticosteroid dose and duration of oral corticosteroid use
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
BID for 84 days
Active study medication
BID for 84 days
The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with AAV on background cyclophosphamide or rituximab treatment.
The primary efficacy objective is to evaluate the efficacy of CCX168 based on the Birmingham Vasculitis Activity Score (BVAS) version 3.
The secondary objectives of this study include assessment of the feasibility of reducing or eliminating the use of corticosteroids in the treatment of subjects with ANCA-associated vasculitis without the need for rescue corticosteroid measures and the effect of CCX168 on several disease parameters.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363388
|Contact: Antonia Potarca||+31 630 892 email@example.com|
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|Study Director:||Pirow Bekker, MD, PhD||ChemoCentryx Inc|