Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis
NCT ID: NCT02222155
Last Updated: 2025-03-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2015-02-04
2016-07-19
Brief Summary
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Funding Source - FDA OOPD
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Detailed Description
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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
QUADRUPLE
Study Groups
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CCX168 low dose plus standard of care
Capsule, 10 mg, twice daily + standard of care for 12 weeks
CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids
CCX168 high dose plus standard of care
Capsule, 30 mg, twice daily + standard of care for 12 weeks
CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids
Placebo, twice daily + standard of care
Capsule, placebo, twice daily + standard of care for 12 weeks
Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids
Interventions
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CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids
CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids
Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids
Eligibility Criteria
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Inclusion Criteria
* Male and female subjects, aged at least 18 years, with new or relapsed AAV where treatment with cyclophosphamide or rituximab would be required
* Use of adequate contraception during, and for at least the three months after, any administration of study medication is 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
* Have at least one "major" item, or at least 3 other items, or at least 2 renal items on the Birmingham Vasculitis Activity Score (BVAS) version 3
* Estimated glomerular filtration rate (eGFR) ≥ 20 mL per minute
Exclusion Criteria
* Any other multi-system autoimmune disease
* Medical history of coagulopathy or bleeding disorder
* Received cyclophosphamide within 12 weeks prior to 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 intravenous corticosteroids, \>3000 mg methylprednisolone equivalent, within 12 weeks prior to screening
* Received an oral daily dose of a corticosteroid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to the screening visit
* Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred; received anti-tumor necrosis factor (TNF) treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), belimumab, tocilizumab, or plasma exchange within 12 weeks prior to 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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Huntsville, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Long Beach, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Miami Springs, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
Charlestown, Massachusetts, United States
Duluth, Minnesota, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
Reno, Nevada, United States
Lebanon, New Hampshire, United States
Albuquerque, New Mexico, United States
Great Neck, New York, United States
Mineola, New York, United States
New York, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
New Bern, North Carolina, United States
Columbus, Ohio, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Chattanooga, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Greenfield Park, Quebec, Canada
Lévis, Quebec, Canada
Countries
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References
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Merkel PA, Niles J, Jimenez R, Spiera RF, Rovin BH, Bomback A, Pagnoux C, Potarca A, Schall TJ, Bekker P; CLASSIC Investigators. Adjunctive Treatment With Avacopan, an Oral C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. ACR Open Rheumatol. 2020 Nov;2(11):662-671. doi: 10.1002/acr2.11185. Epub 2020 Oct 31.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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#FD-R-5414
Identifier Type: OTHER
Identifier Source: secondary_id
CL003_168
Identifier Type: -
Identifier Source: org_study_id
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