Back to resultsProof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum
Primary Purpose
Pyoderma Gangrenosum
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gevokizumab
Sponsored by
About this trial
This is an interventional treatment trial for Pyoderma Gangrenosum focused on measuring Pyoderma Gangrenosum, Classic Pyoderma Gangrenosum, Atypical Pyoderma Gangrenosum, Peristomal Pyoderma Gangrenosum
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gevokizumab
Arm Description
Solution for subcutaneous injection
Outcomes
Primary Outcome Measures
Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01882504
Brief Title
Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum
Official Title
An Open-label, Proof of Concept Study of Gevokizumab in the Treatment of the Acute, Inflammatory Phase of Pyoderma Gangrenosum
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XOMA (US) LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyoderma Gangrenosum
Keywords
Pyoderma Gangrenosum, Classic Pyoderma Gangrenosum, Atypical Pyoderma Gangrenosum, Peristomal Pyoderma Gangrenosum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gevokizumab
Arm Type
Experimental
Arm Description
Solution for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
gevokizumab
Primary Outcome Measure Information:
Title
Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer
Time Frame
Day 1 through Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Miami Shores
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Verona
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum
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