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

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ClinicalTrials.gov Identifier: NCT01363388
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx

May 26, 2011
June 1, 2011
July 26, 2016
August 2011
October 2015   (Final data collection date for primary outcome measure)
  • 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).
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).
Complete list of historical versions of study NCT01363388 on ClinicalTrials.gov Archive Site
Systemic corticosteroid use [ Time Frame: 169 days ]
Systemic corticosteroid use based on total oral corticosteroid dose and duration of oral corticosteroid use
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis
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
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Vasculitis
  • Drug: Placebo
    BID for 84 days
  • Drug: CCX168
    BID for 84 days
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: CCX168
    Active study medication
    Intervention: Drug: CCX168
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.
 
Completed
67
60
January 2016
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Czech Republic,   France,   Germany,   Hungary,   Netherlands,   Poland,   Sweden,   United Kingdom
 
 
NCT01363388
CL002_168
Yes
Not Provided
Not Provided
ChemoCentryx
ChemoCentryx
Not Provided
Study Director: Pirow Bekker, MD, PhD ChemoCentryx Inc
ChemoCentryx
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP