- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01882504
Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum
February 2, 2016 updated by: XOMA (US) LLC
An Open-label, Proof of Concept Study of Gevokizumab in the Treatment of the Acute, Inflammatory Phase of Pyoderma Gangrenosum
The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.
Study Overview
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
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Florida
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Miami, Florida, United States
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Miami Shores, Florida, United States
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Illinois
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Chicago, Illinois, United States
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Maryland
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Baltimore, Maryland, United States
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Michigan
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Ann Arbor, Michigan, United States
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Minnesota
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Minneapolis, Minnesota, United States
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New Jersey
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Verona, New Jersey, United States
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New York
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New York, New York, United States
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North Carolina
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Winston-Salem, North Carolina, United States
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Ohio
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Tennessee
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Knoxville, Tennessee, United States
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Texas
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Arlington, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Virginia
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Norfolk, Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- An established diagnosis of pyoderma gangrenosum
- Currently experiencing an inflammatory episode of pyoderma gangrenosum
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: gevokizumab
Solution for subcutaneous injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer
Time Frame: Day 1 through Day 84
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Day 1 through Day 84
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
June 17, 2013
First Submitted That Met QC Criteria
June 17, 2013
First Posted (Estimate)
June 20, 2013
Study Record Updates
Last Update Posted (Estimate)
February 3, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- X052170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pyoderma Gangrenosum
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SWISS BIOPHARMA MED GmbHCompletedPyoderma | Pyoderma Gangrenosum | Pyoderma Vegetans | Pyoderma Gangrenosum Surrounding Surgical StomaBelarus, Latvia
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Dartmouth-Hitchcock Medical CenterBristol-Myers SquibbNot yet recruiting
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Erasmus Medical CenterNot yet recruitingPyoderma Gangrenosum
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Technical University of MunichNovartisCompletedPyoderma GangrenosumGermany
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Wright State UniversityWake Forest University Health Sciences; Stanford UniversityWithdrawnPyoderma GangrenosumUnited States
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Assistance Publique Hopitaux De MarseilleUnknownPyoderma GangrenosumFrance
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University of ZurichCompleted
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Icahn School of Medicine at Mount SinaiBoehringer IngelheimRecruiting
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InflaRx GmbHRecruitingPhase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma GangrenosumPyoderma GangrenosumUnited States, Spain, Australia, France, Germany, Switzerland, Hungary, Italy, Poland
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AbbVieRecruiting
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