A Clinical Trial to Evaluate the Safety and Efficacy of CCX168, a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).
- Conditions
- on-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV) with mild-to-moderate renal involvementMedDRA version: 17.0Level: PTClassification code 10047115Term: VasculitisSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-001222-15-SE
- Lead Sponsor
- ChemoCentryx, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Clinical diagnosis of granulomatosis with polyangiitis (Wegener’s), microscopic polyangiitis or renal limited vasculitis, consistent with Chapel-Hill consensus definitions (Jennette et al., 2013);
2. Male and postmenopausal (at least 2 years) or surgically sterile female subjects, aged at least 18 years, with new (within 4 weeks prior to screening) or relapsed AAV where treatment with cyclophosphamide or rituximab would be required; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the three months after study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year;
3. 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; If only the IIF assay is positive at screening, and none of the ELISA tests, there must be documentation in the study records of a positive ELISA assay in the past;
4. Have at least one major” item, or at least 3 non-major items, or at least 2 renal items on the BVAS version 3 (see section 11.3);
5. eGFR =20 mL per minute (MDRD);
6. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol; and
7. Judged to be otherwise healthy by the Investigator, based on medical history, physical examination (including electrocardiogram [ECG]), and clinical laboratory assessments. Subjects with clinical laboratory values that are outside of normal limits (other than those specified in the Exclusion Criteria) and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance, may be entered into the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1.Severe disease as determined by rapidly progressive glomerulonephritis such that commencement of renal replacement therapy could be anticipated within 7 days, alveolar hemorrhage leading to Grade 3 or higher hypoxia (i.e., decreased oxygen saturation at rest, e.g., pulse oximeter <88% or PaO2 =55 mm Hg), hemoptysis, rapid-onset mononeuritis multiplex (Grade 3 or higher, leading to severe symptoms that limit self care activities of daily living or requiring an assistive device), or central nervous system involvement;
2.Any other multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg Strauss)angiitis, systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein purpura), rheumatoid vasculitis, Sjögren’s disease, anti-glomerular basement membrane disease, or cryoglobulinemia;
3.Medical history of coagulopathy or bleeding disorder;
4.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 dose on Day 1;
5.Received intravenous corticosteroids, >3000 mg methylprednisolone equivalent, within 12 weeks prior to screening OR >500 mg methylprednisolone equivalent within 4 weeks prior to screening;
6.Have been taking 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. If on an oral corticosteriod at a daily dose of more than 10 mg prednisone equivalent at the time of screening, the oral dose needs to be reduced to a daily dose not exceeding 10 mg prednisone-eqiuvalent prior to Day 1;
7.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 > 0.01x10^9/L); received anti-TNF treatment, abatacept, alemtuzumab, IVIg, belimumab, tocilizumab, or plasma exchange within 12 weeks prior to screening;
8.Symptomatic congestive heart failure requiring prescription medication, clinically evident peripheral edema of cardiac origin, poorly-controlled hypertension (systolic blood pressure >160 or diastolic blood pressure >100), history of unstable angina, myocardial infarction or stroke within 6 months prior to screening;
9.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 cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis;
10.Evidence of tuberculosis based on chest X rays performed during screening as part of the BVAS assessment;
11.Positive HBV, HCV, or HIV viral screening test;
12.Any infection requiring antibiotic treatment within 4 weeks prior to screening (except for prophylactic treatment for Pneumocystis carinii pneumonia [PCP] or treatment for suspected infection that instead turns out ot be a consequence of ANCA vasculitis e.g., pneumonitis);
13.Received a live vaccine within 4 weeks of screening;
14.WBC count less than 4000/uL or neutrophil count less than 2000/uL, or lymphocyte count less than 1000/uL
15.Hemoglobin less than 9 g/dL (or 5.56 mmol/L) at screening;
16.Evidence of hepatic disease; AST, ALT, alkaline phosphatase, or bilirubin > 3 x the upper limit of normal;
17.Prothrombin time (PT) or partial thromboplastin time (PTT) a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method