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
Results First Posted : July 27, 2020
Last Update Posted : July 27, 2020
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Tracking Information | ||||
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First Submitted Date ICMJE | May 26, 2011 | |||
First Posted Date ICMJE | June 1, 2011 | |||
Results First Submitted Date ICMJE | July 7, 2020 | |||
Results First Posted Date ICMJE | July 27, 2020 | |||
Last Update Posted Date | July 27, 2020 | |||
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 |
Proportion of Subjects Achieving at Least 50% Reduction in Birmingham Vasculitis Activity Score [BVAS] by Week 12 and No Worsening in Any Body System [ Time Frame: 84 days ] | |||
Original Primary Outcome Measures ICMJE |
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).
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Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE |
Systemic corticosteroid use [ Time Frame: 169 days ] Systemic corticosteroid use based on total oral corticosteroid dose and duration of oral corticosteroid use
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Vasculitis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
67 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date ICMJE | January 2016 | |||
Actual Primary Completion Date | October 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Belgium, Czechia, France, Germany, Hungary, Netherlands, Poland, Sweden, United Kingdom | |||
Removed Location Countries | Czech Republic | |||
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 ICMJE | Not Provided | |||
Current Responsible Party | ChemoCentryx | |||
Original Responsible Party | Senior VP Medical and Clinical Affairs, ChemoCentryx Inc | |||
Current Study Sponsor ICMJE | ChemoCentryx | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | ChemoCentryx | |||
Verification Date | July 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |