Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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15 February 2016 |
Main ID: |
NCT01882504 |
Date of registration:
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17/06/2013 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum
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Scientific title:
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An Open-label, Proof of Concept Study of Gevokizumab in the Treatment of the Acute, Inflammatory Phase of Pyoderma Gangrenosum |
Date of first enrolment:
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May 2013 |
Target sample size:
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8 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01882504 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- An established diagnosis of pyoderma gangrenosum
- Currently experiencing an inflammatory episode of pyoderma gangrenosum
- Contraceptive measures adequate to prevent pregnancy during the study
Exclusion Criteria:
- Clinical evidence of acutely infected pyoderma gangrenosum
- History of allergic or anaphylactic reactions to monoclonal antibodies
- History of recurrent or chronic systemic infections
- Female subjects who are pregnant, planning to become pregnant, have recently
delivered, or are breast-feeding
Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pyoderma Gangrenosum
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Intervention(s)
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Drug: gevokizumab
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Primary Outcome(s)
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Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer
[Time Frame: Day 1 through Day 84]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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