Pyoderma Gangrenosum Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Verified date | April 2016 |
Source | XOMA (US) LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).
Status | Terminated |
Enrollment | 16 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
XOMA (US) LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Day 126 | No | |
Secondary | The proportions of subjects at Day 126 with a reduction in the target ulcer area of = 75% or = 90% from baseline. | Day 126 | No |
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