A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum
1 other identifier
interventional
15
3 countries
40
Brief Summary
The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers
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
40 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 8, 2014
CompletedFirst Posted
Study publicly available on registry
December 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedApril 27, 2016
April 1, 2016
1.3 years
December 8, 2014
April 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Evaluation of treatment-emergent adverse events;
Up to 2 years
Changes from baseline vital signs, physical examination results, and laboratory test results
Up to 2 years
Changes from baseline concomitant medications use
Up to 2 years
Study Arms (1)
gevokizumab
EXPERIMENTALSolution for subcutaneous injection
Interventions
Eligibility Criteria
You may qualify if:
- Individuals who participated in a previous study of gevokizumab in PG
- A clinical diagnosis of classic 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 (40)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Scottsdale, Arizona, United States
Unknown Facility
Oceanside, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Farmington, Connecticut, United States
Unknown Facility
Coral Gables, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
North Miami Beach, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Macon, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Springfield, Illinois, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Henderson, Nevada, United States
Unknown Facility
Lebanon, New Hampshire, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, 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
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Benowa, Queensland, Australia
Unknown Facility
Woolloongabba, Queensland, Australia
Unknown Facility
Parkville, Victoria, Australia
Unknown Facility
Fremantle, Australia
Unknown Facility
St Leonards, Australia
Unknown Facility
Sydney, Australia
Unknown Facility
Westmead, Australia
Unknown Facility
Markham, Ontario, Canada
Unknown Facility
Richmond Hill, Ontario, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2014
First Posted
December 17, 2014
Study Start
November 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 27, 2016
Record last verified: 2016-04