A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCAAssociated Vasculitis (AAV).

Phase 1

• Conditions: Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis; MedDRA version: 21.1Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 21.1Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-001121-14-IT
• Lead Sponsor: CHEMOCENTRYX, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-01
• Study Start: 2021-01-07
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 331

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) 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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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
11. Any of the following within 12 weeks prior to screening: symptomatic congestive heart failure requiring prescription medication, unstable angina (unless successfully treated with stent or bypass surgery), clinically significant cardiac arrhythmia, myocardial infarction or stroke
12. History or presence of any form of cancer within the 5 years prior to screening, with the exception of excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified