A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis
|ClinicalTrials.gov Identifier: NCT01363388|
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : July 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Vasculitis||Drug: Placebo Drug: CCX168||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||January 2016|
|Placebo Comparator: Placebo||
BID for 84 days
Active study medication
BID for 84 days
- Safety of CCX168 in subjects with AAV [ Time Frame: 169 days ]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 ]Efficacy will be assessed by BVAS (a global disease activity index).
- Systemic corticosteroid use [ Time Frame: 169 days ]Systemic corticosteroid use based on total oral corticosteroid dose and duration of oral corticosteroid use
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363388
|Prague, Czech Republic|
|Boulogne sur Mer, France|
|Saint Jacques, France|
|Berkshire, United Kingdom|
|Birmingham, United Kingdom|
|Cambridge, United Kingdom|
|London, United Kingdom|
|Manchester, United Kingdom|
|Oxford, United Kingdom|
|Study Director:||Pirow Bekker, MD, PhD||ChemoCentryx Inc|