A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis

Tracking Information
First Submitted Date ICMJE	May 26, 2011
First Posted Date ICMJE	June 1, 2011
Last Update Posted Date	July 26, 2016
Study Start Date ICMJE	August 2011
Actual Primary Completion Date	October 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 22, 2014)	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).
Original Primary Outcome Measures ICMJE; (submitted: May 30, 2011)	Safety of CCX168 in subjects with AARV [ Time Frame: 169 days ]; Safety assessments include adverse events, physical examination abnormalities, vital signs and clinical laboratory tests (including blood chemistry, hematology and urinalysis).
Change History	Complete list of historical versions of study NCT01363388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 30, 2011)	Systemic corticosteroid use [ Time Frame: 169 days ]; Systemic corticosteroid use based on total oral corticosteroid dose and duration of oral corticosteroid use
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis
Official Title ICMJE	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
Brief Summary	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.
Detailed Description	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 ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition ICMJE	Vasculitis
Intervention ICMJE	Drug: Placebo BID for 84 days; Drug: CCX168 BID for 84 days
Study Arms	Placebo Comparator: Placebo Intervention: Drug: Placebo; Experimental: CCX168 Active study medication Intervention: Drug: CCX168
Publications *	Cravedi P, Leventhal J, Lakhani P, Ward SC, Donovan MJ, Heeger PS. Immune cell-derived C3a and C5a costimulate human T cell alloimmunity. Am J Transplant. 2013 Oct;13(10):2530-9. doi: 10.1111/ajt.12405. Epub 2013 Sep 6.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 20, 2016)	67
Original Estimated Enrollment ICMJE; (submitted: May 30, 2011)	60
Actual Study Completion Date	January 2016
Actual Primary Completion Date	October 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Key Inclusion Criteria: Clinical diagnosis of granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis or renal limited vasculitis; Male and postmenopausal or surgically sterile female subjects aged at least 18 years with new or relapsed AAV where treatment with cyclophosphamide or rituximab would be required; Positive indirect immunofluorescence (IIF) test for P-ANCA or C-ANCA, or positive ELISA test for anti-proteinase-3 (PR3) or anti-myeloperoxidase (MPO) at screening; Estimated glomerular filtration rate (eGFR) ≥ 20mL/min; Have at least one "major" item, or at least 3 non-major items, or at least 2 renal items on the BVAS version 3 Key Exclusion Criteria: Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage, hemoptysis, rapid-onset mononeuritis multiplex or central nervous system involvement; Any other multi-system autoimmune disease; Medical history of coagulopathy or bleeding disorder; 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 or rituximab dose on Day 1; Received high-dose intravenous corticosteroids within 4 weeks of screening; On an oral dose of a corticosteroid of more than 10mg prednisone-equivalent at the time of screening; 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, IVIg or plasma exchange within 12 weeks of screening
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Austria, Belgium, Czech Republic, France, Germany, Hungary, Netherlands, Poland, Sweden, United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01363388
Other Study ID Numbers ICMJE	CL002_168
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	ChemoCentryx
Study Sponsor ICMJE	ChemoCentryx
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Pirow Bekker, MD, PhD ChemoCentryx Inc
PRS Account	ChemoCentryx
Verification Date	July 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP