Pyoderma Gangrenosum
Conditions
Keywords
Pyoderma Gangrenosum, Classic Pyoderma Gangrenosum
Brief summary
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).
Interventions
Sponsors
XOMA (US) LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline. | Day 126 |
Countries
United States
Outcome results
None listed