A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
NCT ID: NCT02994927
Last Updated: 2025-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
331 participants
INTERVENTIONAL
2017-03-15
2019-11-01
Brief Summary
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Detailed Description
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This is a randomized, double-blind, active-controlled Phase 3 study to evaluate the safety and efficacy of the orally-administered, selective C5aR inhibitor CCX168 (avacopan) in inducing and sustaining remission in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) treated concomitantly with Rituximab or Cyclophosphamide/Azathioprine.
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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Prednisone group
Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
Prednisone
Avacopan-matching placebo twice daily orally for 52 weeks (364 days):
\- Three avacopan-matching placebo capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.
Oral prednisone tapering regimen over 20 weeks (140 days):
* Prednisone 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was \<55 kg, starting on Day 1 with tapering according to the protocol-specified schedule.
* Adolescents who weighed ≤37 kg started at a prednisone dose of 30 mg per day.
Cyclophosphamide
Orally or intravenously administered
Rituximab
Intravenously administered
Azathioprine
Orally administered
Avacopan group
Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
Avacopan
Avacopan 30 mg twice daily orally for 52 weeks (364 days):
\- Three 10 mg avacopan capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.
Oral prednisone-matching placebo tapering regimen over 20 weeks (140 days):
* Prednisone-matching placebo capsules equivalent to 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was \<55 kg, starting on Day 1 with tapering according to a protocol-specified schedule.
* Adolescents who weighed ≤37 kg started at a prednisone-matching placebo dose of 30 mg per day.
Cyclophosphamide
Orally or intravenously administered
Rituximab
Intravenously administered
Azathioprine
Orally administered
Interventions
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Avacopan
Avacopan 30 mg twice daily orally for 52 weeks (364 days):
\- Three 10 mg avacopan capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.
Oral prednisone-matching placebo tapering regimen over 20 weeks (140 days):
* Prednisone-matching placebo capsules equivalent to 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was \<55 kg, starting on Day 1 with tapering according to a protocol-specified schedule.
* Adolescents who weighed ≤37 kg started at a prednisone-matching placebo dose of 30 mg per day.
Prednisone
Avacopan-matching placebo twice daily orally for 52 weeks (364 days):
\- Three avacopan-matching placebo capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.
Oral prednisone tapering regimen over 20 weeks (140 days):
* Prednisone 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was \<55 kg, starting on Day 1 with tapering according to the protocol-specified schedule.
* Adolescents who weighed ≤37 kg started at a prednisone dose of 30 mg per day.
Cyclophosphamide
Orally or intravenously administered
Rituximab
Intravenously administered
Azathioprine
Orally administered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female subjects, aged at least 18 years, with newly-diagnosed or relapsed associated vasculitis (AAV) where treatment with cyclophosphamide or rituximab is needed; where approved by Regulatory Agencies, adolescents (12-17 year old) may be enrolled
* Use of adequate contraception
* Positive test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO)
* At least 1 major item, or at least 3 non-major items, or at least the 2 renal items of proteinuria and hematuria on Birmingham Vasculitis Activity Score (BVAS)
* Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\^2 at screening
Exclusion Criteria
* Alveolar hemorrhage requiring pulmonary ventilation support at screening
* Any other known multi-system autoimmune disease
* Required dialysis or plasma exchange within 12 weeks prior to screening
* Have a kidney transplant
* 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 glucocorticoids, \>3000 mg methylprednisolone equivalent, within 4 weeks prior to screening
* Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening
* Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred (i.e., CD19 count \> 0.01x10\^9/L); received anti-tumor necrosis factor (TNF) treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), belimumab, tocilizumab, or eculizumab within 12 weeks prior to screening
* For patients scheduled to receive cyclophosphamide treatment, urinary outflow obstruction, active infection (especially varicella zoster infection), or platelet count \<50,000/μL before start of dosing
* Participated previously in a CCX168 study
12 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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Clinical Trial Site
Huntsville, Alabama, United States
Clinical Trial Site
Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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Santa Monica, California, United States
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Aurora, Colorado, United States
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Washington D.C., District of Columbia, United States
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Daytona Beach, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Meridian, Idaho, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Lexington, Kentucky, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Great Neck, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Greenville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Duncansville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Seattle, Washington, United States
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Adelaide, , Australia
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Auchenflower, , Australia
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Brisbane, , Australia
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Clayton, , Australia
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Concord, , Australia
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Heidelberg, , Australia
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Liverpool, , Australia
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Nambour, , Australia
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Nedlands, , Australia
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Randwick, , Australia
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Saint Albans, , Australia
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Southport, , Australia
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St Leonards, , Australia
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Westmead, , Australia
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Woolloongabba, , Australia
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Feldkirch, , Austria
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Graz, , Austria
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Innsbruck, , Austria
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Antwerp, , Belgium
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Brussels, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Calgary, , Canada
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Greenfield Park, , Canada
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Hamilton, , Canada
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Montreal, , Canada
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Québec, , Canada
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Sherbrooke, , Canada
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Toronto, , Canada
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Vancouver, , Canada
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Olomouc, , Czechia
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Prague, , Czechia
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Aalborg, , Denmark
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Aarhus, , Denmark
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Copenhagen, , Denmark
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Odense, , Denmark
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Roskilde, , Denmark
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Angers, , France
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Bordeaux, , France
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Boulogne-sur-Mer, , France
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Brest, , France
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Bron, , France
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Caen, , France
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Colmar, , France
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Grenoble, , France
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Marseille, , France
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Metz, , France
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Nantes, , France
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Nîmes, , France
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Paris, , France
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Toulouse, , France
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Valenciennes, , France
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Aachen, , Germany
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Bad Bramstedt, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Essen, , Germany
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Freiburg im Breisgau, , Germany
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Fulda, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Jena, , Germany
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Kirchheim unter Teck, , Germany
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Leipzig, , Germany
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Ludwigshafen, , Germany
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Lübeck, , Germany
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Mannheim, , Germany
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Munich, , Germany
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Tübingen, , Germany
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Villingen-Schwenningen, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Cork, , Ireland
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Dublin, , Ireland
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Ancona, , Italy
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Florence, , Italy
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Genova, , Italy
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Milan, , Italy
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Monza, , Italy
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Parma, , Italy
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Reggio Emilia, , Italy
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Torino, , Italy
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Udine, , Italy
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Aichi, , Japan
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Akita, , Japan
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Chiba, , Japan
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Hiroshima, , Japan
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Hokkaido, , Japan
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Ishikawa, , Japan
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Kagawa, , Japan
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Kanagawa, , Japan
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Kobe, , Japan
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Miyazaki, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Saitama, , Japan
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Shimane, , Japan
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Shizuoka, , Japan
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Tokyo, , Japan
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Toyama, , Japan
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Yokohama, , Japan
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Groningen, , Netherlands
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Leiden, , Netherlands
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Rotterdam, , Netherlands
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Christchurch, , New Zealand
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Dunedin, , New Zealand
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Grafton, , New Zealand
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Hamilton, , New Zealand
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Takapuna, , New Zealand
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Nordbyhagen, , Norway
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Oslo, , Norway
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Tromsø, , Norway
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Badalona, , Spain
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Barcelona, , Spain
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Burela de Cabo, , Spain
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Lleida, , Spain
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Madrid, , Spain
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San Sebastián, , Spain
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Linköping, , Sweden
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Lund, , Sweden
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Örebro, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Basel, , Switzerland
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Bern, , Switzerland
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Fribourg, , Switzerland
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Lausanne, , Switzerland
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Sankt Gallen, , Switzerland
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Zurich, , Switzerland
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Aberdeen, , United Kingdom
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Basildon, , United Kingdom
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Birmingham, , United Kingdom
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Bristol, , United Kingdom
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Cambridge, , United Kingdom
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Canterbury, , United Kingdom
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Cardiff, , United Kingdom
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Carshalton, , United Kingdom
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Dorchester, , United Kingdom
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Dudley, , United Kingdom
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Exeter, , United Kingdom
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Glasgow, , United Kingdom
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Inverness, , United Kingdom
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Kirkcaldy, , United Kingdom
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Leeds, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Newcastle, , United Kingdom
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Nottingham, , United Kingdom
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Oxford, , United Kingdom
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Reading, , United Kingdom
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Salford, , United Kingdom
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Westcliff-on-Sea, , United Kingdom
Countries
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References
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Geetha D, Neumann T, Karras A, Cid MC, Merkel PA, Bray S, Bozeman AM, Jayne DRW; Members of the ADVOCATE Study Group. Efficacy and safety of avacopan for treatment of patients with ANCA-associated vasculitis receiving cyclophosphamide. RMD Open. 2025 Oct 5;11(4):e005743. doi: 10.1136/rmdopen-2025-005743.
Geetha D, Dua A, Yue H, Springer J, Salvarani C, Jayne D, Merkel P; ADVOCATE Study Group. Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial. Ann Rheum Dis. 2024 Jan 11;83(2):223-232. doi: 10.1136/ard-2023-224816.
Soulsby WD. Journal Club Review of "Avacopan for the Treatment of ANCA-Associated Vasculitis". ACR Open Rheumatol. 2022 Jul;4(7):558-561. doi: 10.1002/acr2.11412. Epub 2022 Feb 15.
Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med. 2021 Feb 18;384(7):599-609. doi: 10.1056/NEJMoa2023386.
Merkel PA, Jayne DR, Wang C, Hillson J, Bekker P. Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial. JMIR Res Protoc. 2020 Apr 7;9(4):e16664. doi: 10.2196/16664.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ADVOCATE
Identifier Type: OTHER
Identifier Source: secondary_id
CL010_168
Identifier Type: -
Identifier Source: org_study_id
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