A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis
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| ClinicalTrials.gov Identifier: NCT01363388 |
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Recruitment Status :
Completed
First Posted : June 1, 2011
Last Update Posted : July 26, 2016
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Sponsor:
ChemoCentryx
Information provided by (Responsible Party):
ChemoCentryx
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Brief Summary:
The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement C5a receptor plus cyclophosphamide or rituximab.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vasculitis | Drug: Placebo Drug: CCX168 | Phase 2 |
The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with AAV on background cyclophosphamide or rituximab treatment.
The primary efficacy objective is to evaluate the efficacy of CCX168 based on the Birmingham Vasculitis Activity Score (BVAS) version 3.
The secondary objectives of this study include assessment of the feasibility of reducing or eliminating the use of corticosteroids in the treatment of subjects with ANCA-associated vasculitis without the need for rescue corticosteroid measures and the effect of CCX168 on several disease parameters.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 67 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background of Cyclophosphamide or Rituximab Treatment |
| Study Start Date : | August 2011 |
| Actual Primary Completion Date : | October 2015 |
| Actual Study Completion Date : | January 2016 |
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
BID for 84 days |
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Experimental: CCX168
Active study medication
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Drug: CCX168
BID for 84 days |
Primary Outcome Measures :
- Safety of CCX168 in subjects with AAV [ Time Frame: 169 days ]Safety assessments include adverse events, physical examination abnormalities, vital signs and clinical laboratory tests (including blood chemistry, hematology and urinalysis).
- Efficacy of CCX168 in subjects with AAV [ Time Frame: 169 days ]Efficacy will be assessed by BVAS (a global disease activity index).
Secondary Outcome Measures :
- Systemic corticosteroid use [ Time Frame: 169 days ]Systemic corticosteroid use based on total oral corticosteroid dose and duration of oral corticosteroid use
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Clinical diagnosis of granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis or renal limited vasculitis
- Male and postmenopausal or surgically sterile female subjects aged at least 18 years with new or relapsed AAV where treatment with cyclophosphamide or rituximab would be 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
- Estimated glomerular filtration rate (eGFR) ≥ 20mL/min
- Have at least one "major" item, or at least 3 non-major items, or at least 2 renal items on the BVAS version 3
Key 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 of 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 high-dose intravenous corticosteroids within 4 weeks of screening
- On an oral dose of a corticosteroid of more than 10mg prednisone-equivalent at the time of screening
- Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred; received anti-TNF treatment, abatacept, alemtuzumab, IVIg or plasma exchange within 12 weeks of screening
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363388
Locations
| Austria | |
| Feldkirch, Austria | |
| Innsbruck, Austria | |
| Linz, Austria | |
| Belgium | |
| Brussels, Belgium | |
| Edegem, Belgium | |
| Gent, Belgium | |
| Leuven, Belgium | |
| Liege, Belgium | |
| Roeselare, Belgium | |
| Czech Republic | |
| Prague, Czech Republic | |
| France | |
| Bordeaux, France | |
| Boulogne sur Mer, France | |
| Brest, France | |
| Colmar, France | |
| Grenoble, France | |
| Nantes, France | |
| Paris, France | |
| Saint Jacques, France | |
| Valenciennes, France | |
| Germany | |
| Berlin, Germany | |
| Cologne, Germany | |
| Dresden, Germany | |
| Freiburg, Germany | |
| Fulda, Germany | |
| Heidelberg, Germany | |
| Hungary | |
| Budapest, Hungary | |
| Netherlands | |
| Groningen, Netherlands | |
| Leiden, Netherlands | |
| Rotterdam, Netherlands | |
| Utrecht, Netherlands | |
| Poland | |
| Bialystok, Poland | |
| Katowice, Poland | |
| Szczecin, Poland | |
| Wroclaw, Poland | |
| Sweden | |
| Linkoping, Sweden | |
| Lund, Sweden | |
| Malmo, Sweden | |
| Stockholm, Sweden | |
| United Kingdom | |
| Berkshire, United Kingdom | |
| Birmingham, United Kingdom | |
| Cambridge, United Kingdom | |
| London, United Kingdom | |
| Manchester, United Kingdom | |
| Oxford, United Kingdom | |
Sponsors and Collaborators
ChemoCentryx
Investigators
| Study Director: | Pirow Bekker, MD, PhD | ChemoCentryx Inc |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ChemoCentryx |
| ClinicalTrials.gov Identifier: | NCT01363388 |
| Other Study ID Numbers: |
CL002_168 |
| First Posted: | June 1, 2011 Key Record Dates |
| Last Update Posted: | July 26, 2016 |
| Last Verified: | July 2016 |
Additional relevant MeSH terms:
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Vasculitis Vascular Diseases Cardiovascular Diseases |