A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis
NCT ID: NCT01363388
Last Updated: 2025-03-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2011-09-30
2016-01-31
Brief Summary
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Detailed Description
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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 acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo plus a full dose of oral glucocorticoids for steps 1 and 2 of the study
Placebo
BID for 84 days
CCX168
30 mg Active study medication, plus either two-thirds reduced dose of oral glucocorticoids for step 1 of the study, or no oral glucocorticoids for step 2 of the study
CCX168
BID for 84 days
Interventions
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Placebo
BID for 84 days
CCX168
BID for 84 days
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Feldkirch, , Austria
Innsbruck, , Austria
Linz, , Austria
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Liège, , Belgium
Roeselare, , Belgium
Prague, , Czechia
Bordeaux, , France
Boulogne-sur-Mer, , France
Brest, , France
Colmar, , France
Grenoble, , France
Nantes, , France
Paris, , France
Saint-Jacques, , France
Valenciennes, , France
Berlin, , Germany
Cologne, , Germany
Dresden, , Germany
Freiburg im Breisgau, , Germany
Fulda, , Germany
Heidelberg, , Germany
Budapest, , Hungary
Groningen, , Netherlands
Leiden, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Bialystok, , Poland
Katowice, , Poland
Szczecin, , Poland
Wroclaw, , Poland
Linköping, , Sweden
Lund, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Birmingham, , United Kingdom
Cambridge, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Oxford, , United Kingdom
Reading, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Randomized Trial of C5a Receptor Inhibitor Avacopan in ANCA-Associated Vasculitis
Other Identifiers
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CL002_168
Identifier Type: -
Identifier Source: org_study_id
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