- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02315417
An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
April 25, 2016 updated by: XOMA (US) LLC
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 3
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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Florida
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Coral Gables, Florida, United States
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North Miami Beach, Florida, United States
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Michigan
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Ann Arbor, Michigan, United States
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Missouri
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St. Louis, Missouri, United States
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New Hampshire
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Lebanon, New Hampshire, 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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Columbus, Ohio, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Texas
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Houston, Texas, United States
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Lubbock, Texas, 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:
- 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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: gevokizumab
Solution for subcutaneous injection (Part 1, Group B)
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Placebo Comparator: Placebo
Solution for subcutaneous injection (Part 1, Group A)
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Experimental: gevokizumab open-label
Solution for subcutaneous injection (Part 2, Open-label)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Day 126
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.
Time Frame: Day 126
|
Day 126
|
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
November 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
December 5, 2014
First Submitted That Met QC Criteria
December 8, 2014
First Posted (Estimate)
December 11, 2014
Study Record Updates
Last Update Posted (Estimate)
April 27, 2016
Last Update Submitted That Met QC Criteria
April 25, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- X052172
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
-
Wright State UniversityWake Forest University Health Sciences; Stanford UniversityWithdrawnPyoderma GangrenosumUnited States
-
Assistance Publique Hopitaux De MarseilleUnknownPyoderma GangrenosumFrance
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University of ZurichCompleted
-
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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-
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-
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