A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine - CCX16810

Chemocentryx0 sites6 target enrollmentTBD

ConditionsANCA Associated Vasculitis 10047066

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: ANCA Associated Vasculitis
Sponsor: Chemocentryx
Enrollment: 6
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

September 23, 2019

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

Chemocentryx

Eligibility Criteria

Inclusion Criteria

•1\. Clinical diagnosis of granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, consistent with Chapel\-Hill Consensus Conference definitions
•2\. Aged at least 18 years, with newly\-diagnosed or relapsed AAV where treatment with cyclophosphamide or rituximab is needed; where approved, adolescents (12\-17 year old) may be enrolled
•3\. Positive test for anti\-PR3 or anti\-MPO (current or historic) antibodies
•4\. At least one major item, or at least 3 minor items, or at least the 2 renal items of proteinuria and hematuria in the BVAS
•5\. Estimated glomerular filtration rate \*15 mL/minute/1\.73 m2 (using the MDRD method for adults, and modified Schwartz equation for adolescents) at screening
•6\. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol; written Informed Consent should be obtained from the legal guardian in accordance with regional laws or regulations for patients 12 to 17 years of age
•7\. Judged by the Investigator to be fit for the study, based on medical history, physical examination (including electrocardiogram \[ECG]), and clinical laboratory assessments.

Exclusion Criteria

•1\. Pregnant or breast\-feeding
•2\. Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study
•3\. Any other known multi\-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg\-Strauss), systemic lupus erythematosus, IgA vasculitis (Henoch\-Schönlein), rheumatoid vasculitis, Sjögren's syndrome, anti\-glomerular basement membrane disease, or cryoglobulinemic vasculitis
•4\. Required dialysis or plasma exchange within 12 weeks prior to screening
•5\. Have had a kidney transplant
•6\. 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
•7\. Received intravenous glucocorticoids, \>3000 mg methylprednisolone equivalent, within 4 weeks prior to screening
•8\. 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 the screening visit
•9\. 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\.01x109/L); received anti\-TNF treatment, abatacept, alemtuzumab, IVIg, belimumab, tocilizumab, or eculizumab within 12 weeks prior to screening
•10\. Currently taking a strong inducer of the cytochrome P450 3A4 (CYP3A4\) enzyme, such as carbamazepine, phenobarbital, phenytoin, rifampin, or St. John\*s wort