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Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02222155
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx

Study Description
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Brief Summary:

The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

Funding Source - FDA OOPD


Condition or disease Intervention/treatment Phase
ANCA-associated Vasculitis Drug: CCX168 low dose plus standard of care Drug: CCX168 high dose plus standard of care Other: Placebo BID plus standard of care Phase 2

Detailed Description:
Complement 5a and its receptor C5aR (CD88) is involved in the pathogenesis of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. This is a randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety and efficacy of the C5aR inhibitor CCX168 in subjects with ANCA-associated vasculitis. The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose Assessment Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Study Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis
Drug Information available for: Avacopan

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CCX168 low dose plus standard of care
Capsule, 10mg, twice daily, 12 weeks
 Drug: CCX168 low dose plus standard of care
Active Comparator: CCX168 high dose plus standard of care
Capsule, 30 mg, twice daily, 12 weeks
 Drug: CCX168 high dose plus standard of care
Placebo Comparator: Placebo BID plus standard of care
Capsule, placebo, twice daily, 12 weeks
 Other: Placebo BID plus standard of care


Outcome Measures
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Primary Outcome Measures :
  1. BVAS [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. eGFR [ Time Frame: 12 weeks ]
  2. Hematuria [ Time Frame: 12 weeks ]
  3. Albuminuria [ Time Frame: 12 weeks ]
  4. Urinary monocyte chemoattractant protein-1 (MCP-1) [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis or renal limited vasculitis
  • 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:

  • 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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222155


Locations
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United States, Alabama
Huntsville, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
Long Beach, California, United States
Los Angeles, California, United States
San Francisco, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Miami Springs, Florida, United States
Tampa, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Massachusetts
Charleston, Massachusetts, United States
United States, Minnesota
Duluth, Minnesota, United States
United States, Mississippi
Tupelo, Mississippi, United States
United States, Missouri
St Louis, Missouri, United States
United States, Nevada
Reno, Nevada, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Great Neck, New York, United States
Mineola, New York, United States
New York, New York, United States
Syracuse, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
New Bern, North Carolina, United States
United States, Ohio
Columbus, Ohio, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Chattanooga, Tennessee, United States
United States, Texas
Amarillo, Texas, United States
Austin, Texas, United States
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Washington
Seattle, Washington, United States
Canada, Alberta
Calgary, Alberta, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Greenfield Park, Quebec, Canada
Levis, Quebec, Canada
Sponsors and Collaborators
ChemoCentryx
Investigators
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Principal Investigator: Patrick Nachman, MD University of North Carolina Kidney Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT02222155    
Other Study ID Numbers: CL003_168
#FD-R-5414 ( Other Identifier: Orphan Products Development Grant )
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Keywords provided by ChemoCentryx:
ANCA-associated vasculitis
complement
vasculitis
C5aR
Additional relevant MeSH terms:
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Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
 Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases