EUCTR2016-001121-14-IT
Active, not recruiting
Phase 1
Randomized, Double-Blind, Placebo-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
ConditionsAnti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitisMedDRA version: 21.1Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 21.1Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
- Sponsor
- CHEMOCENTRYX, INC.
- Enrollment
- 331
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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) 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
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
Outcomes
Primary Outcomes
Not specified
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