Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum
An Open-label, Proof of Concept Study of Gevokizumab in the Treatment of the Acute, Inflammatory Phase of Pyoderma Gangrenosum
1 other identifier
interventional
8
1 country
19
Brief Summary
The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2013
19 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
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFebruary 3, 2016
February 1, 2016
2.4 years
June 17, 2013
February 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer
Day 1 through Day 84
Study Arms (1)
gevokizumab
EXPERIMENTALSolution for subcutaneous injection
Interventions
Eligibility Criteria
You may qualify if:
- An established diagnosis of pyoderma gangrenosum
- Currently experiencing an inflammatory episode of pyoderma gangrenosum
- 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 (19)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Miami Shores, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
Verona, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Arlington, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2013
First Posted
June 20, 2013
Study Start
May 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
February 3, 2016
Record last verified: 2016-02