An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
1 other identifier
interventional
16
1 country
12
Brief Summary
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2014
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 5, 2014
CompletedFirst Posted
Study publicly available on registry
December 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 27, 2016
April 1, 2016
1.3 years
December 5, 2014
April 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.
Day 126
Study Arms (3)
gevokizumab
EXPERIMENTALSolution for subcutaneous injection (Part 1, Group B)
Placebo
PLACEBO COMPARATORSolution for subcutaneous injection (Part 1, Group A)
gevokizumab open-label
EXPERIMENTALSolution for subcutaneous injection (Part 2, Open-label)
Interventions
Eligibility Criteria
You may qualify if:
- A clinical diagnosis of classic pyoderma gangrenosum
- An active pyoderma gangrenosum ulcer
- Contraceptive measures adequate to prevent pregnancy during the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XOMA (US) LLClead
Study Sites (12)
Unknown Facility
Coral Gables, Florida, United States
Unknown Facility
North Miami Beach, Florida, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Lebanon, New Hampshire, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Lubbock, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2014
First Posted
December 11, 2014
Study Start
November 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 27, 2016
Record last verified: 2016-04