NCT02315417TerminatedPhase 3
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- XOMA (US) LLC
- Enrollment
- 16
- Primary Endpoint
- 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
Study Overview
Brief Summary
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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/exclusion criteria may apply
Arms & Interventions
gevokizumab
Experimental
Solution for subcutaneous injection (Part 1, Group B)
Intervention: gevokizumab (Drug)
Placebo
Placebo Comparator
Solution for subcutaneous injection (Part 1, Group A)
Intervention: Placebo (Drug)
gevokizumab open-label
Experimental
Solution for subcutaneous injection (Part 2, Open-label)
Intervention: gevokizumab open-label (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.(Day 126)
Investigators
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