ANCA-associated Vasculitis Clinical Trial
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
Verified date | July 2023 |
Source | ChemoCentryx |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 42 |
Est. completion date | July 19, 2016 |
Est. primary completion date | April 24, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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to screening; if on azathioprine, mycophenolate mofetil, or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1 - Received intravenous corticosteroids, 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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ChemoCentryx |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Adverse Events | This is a safety study to assess the overall rates of treatment-emergent adverse events (TEAEs) across all study arms. | Baseline to Day 85 | |
Primary | Proportion of Patients Achieving Disease Response Based on BVAS at Day 85 | Proportion of Patients achieving 50% reduction in the Birmingham Vasculitis Activity Score [BVAS] at Day 85 and no worsening in any body system component at day 85 | Day 85 | |
Secondary | Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85. | Proportion of subjects achieving disease remission based on Birmingham Vasculitis Activity Score (BVAS) defined as 0 at Day 85. | Day 85 | |
Secondary | Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85. | Proportion of subjects achieving early disease remission based on Birmingham Vasculitis Activity Score (BVAS) score of 0 at Days 29 and 85. | Day 29 and 85 | |
Secondary | Percent Change From Baseline to Day 85 in BVAS. | The Birmingham Vasculitis Activity (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). A negative percentage change indicated improvement in health. | Baseline to Day 85 | |
Secondary | Proportion of Subjects With Hematuria and Albuminuria at Baseline Who Showed a Renal Response at Day 85 | Renal responses among patients (who had hematuria or albuminuria at baseline determined secondary to ANCA-associated vasculitis) were defined as improvement in the following parameters of renal vasculitis: (1) increase from baseline to day 85 in eGFR [Modification of Diet in Renal Disease (MDRD equation)], (2) decrease from baseline to day 85 in hematuria (microscopic count of urinary red blood cells [RBC]), and (3) decrease from baseline to day 85 in albuminuria (first morning urinary albumin:creatinine ratio). | Day 85 | |
Secondary | Change in Estimated Glomerular Filtration Rate at Day 85 | Mean Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula, for patients with renal disease at baseline. | Baseline to Day 85 | |
Secondary | Percentage Change in Estimated Glomerular Filtration Rate at Day 85 | Mean Percentage Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula. | Baseline to Day 85 | |
Secondary | Percent Change of Urinary Red Blood Cells in Patient With Hematuria From Baseline to Day 85 | Mean Percent Change of Urinary Red Blood Cells (UBC) in Patients in Hematuria at Baseline. | Baseline to Day 85 | |
Secondary | Percent Change of Urinary Albumin:Creatinine Ratio in Patients With Albuminuria From Baseline to Day 85 | Mean Percent Change of Urinary Albumin:Creatinine Ratio in Patients with Albuminuria at Baseline | Baseline to Day 85 | |
Secondary | Percent Change of Urinary MCP-1:Creatinine Ratio From Baseline to Day 85 | Mean Percent Change of Urinary monocyte chemoattractant protein (MCP-1:creatinine) ratio from Baseline | Baseline to Day 85 | |
Secondary | Change From Baseline to Day 85 in the VDI | The Vasculitis Damage Index (VDI) is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health) | Baseline to Day 85 | |
Secondary | Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 | Change from Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the Short Form-36 (SF-36v2) SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health). | Baseline to Day 85 | |
Secondary | Mean Change From Baseline to Day 85 in Health-related Quality-of-life as Measured by the EQ-5D-5L | Mean Change from baseline to Day 85 in health-related quality-of-life as measured by the Euro Quality-of-Life-5 Domains-5 Levels (EQ-5D-5L).
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health). |
Baseline to Day 85 | |
Secondary | Proportion of Subjects Requiring Rescue Glucocorticoid Treatment From Baseline to Day 85 | Proportion of subjects requiring rescue glucocorticoid treatment from Baseline to Day 85 | Baseline to Day 85 |
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