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Trial record 1 of 1 for:    nct02222155
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Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02222155
First Posted: August 21, 2014
Last Update Posted: November 16, 2016
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.
Information provided by (Responsible Party):
ChemoCentryx
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by ChemoCentryx:

Primary Outcome Measures:
  • BVAS [ Time Frame: 12 weeks ]

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

Enrollment: 42
Study Start Date: September 2014
Study Completion Date: September 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


  Show 43 Study Locations
Sponsors and Collaborators
ChemoCentryx
Investigators
Principal Investigator: Patrick Nachman, MD University of North Carolina Kidney Center
  More Information

Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT02222155     History of Changes
Other Study ID Numbers: CL003_168
#FD-R-5414 ( Other Identifier: Orphan Products Development Grant )
First Submitted: August 19, 2014
First Posted: August 21, 2014
Last Update Posted: November 16, 2016
Last Verified: November 2016

Keywords provided by ChemoCentryx:
ANCA-associated vasculitis
complement
vasculitis
C5aR

Additional relevant MeSH terms:
Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases
Antibodies, Antineutrophil Cytoplasmic
Immunologic Factors
Physiological Effects of Drugs