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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 May 2016 |
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Main ID: |
NCT02326740 |
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Date of registration:
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22/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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9 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02326740 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Canada
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A clinical diagnosis of classic pyoderma gangrenosum
- An active pyoderma gangrenosum ulcer
- 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: Placebo
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Drug: gevokizumab open-label
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Drug: gevokizumab
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Primary Outcome(s)
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The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment
[Time Frame: Day 126]
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Secondary Outcome(s)
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The proportions of subjects at Day 126 with a reduction in the target ulcer area of = 75% or = 90% from baseline.
[Time Frame: Day 126]
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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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