Overview

This trial has been completed.

Condition anca-associated vasculitis
Treatments ccx168 low dose plus standard of care, ccx168 high dose plus standard of care, placebo bid plus standard of care
Phase phase 2
Sponsor ChemoCentryx
Start date September 2014
End date April 2016
Trial size 42 participants
Trial identifier NCT02222155, #FD-R-5414, CL003_168

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Capsule, 10mg, twice daily, 12 weeks
ccx168 low dose plus standard of care
(Active Comparator)
Capsule, 30 mg, twice daily, 12 weeks
ccx168 high dose plus standard of care
(Placebo Comparator)
Capsule, placebo, twice daily, 12 weeks
placebo bid plus standard of care

Primary Outcomes

Measure
BVAS
time frame: 12 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Patrick Nachman, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by ChemoCentryx.