Status:
COMPLETED
Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis
Lead Sponsor:
Amgen
Conditions:
ANCA-associated Vasculitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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to screening; if on azathioprine, mycophenolate mofetil, or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1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
Key Trial Info
Start Date :
February 4 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02222155
Start Date
February 4 2015
End Date
July 19 2016
Last Update
March 13 2025
Active Locations (43)
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1
Huntsville, Alabama, United States
2
Phoenix, Arizona, United States
3
Tucson, Arizona, United States
4
Long Beach, California, United States