Back to resultsAn Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Primary Purpose
Pyoderma Gangrenosum
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
gevokizumab
Placebo
gevokizumab open-label
Sponsored by
About this trial
This is an interventional treatment trial for Pyoderma Gangrenosum focused on measuring Pyoderma Gangrenosum, Classic Pyoderma Gangrenosum
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
gevokizumab
Placebo
gevokizumab open-label
Arm Description
Solution for subcutaneous injection (Part 1, Group B)
Solution for subcutaneous injection (Part 1, Group A)
Solution for subcutaneous injection (Part 2, Open-label)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02315417
Brief Title
An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XOMA (US) LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gevokizumab
Arm Type
Experimental
Arm Description
Solution for subcutaneous injection (Part 1, Group B)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Solution for subcutaneous injection (Part 1, Group A)
Arm Title
gevokizumab open-label
Arm Type
Experimental
Arm Description
Solution for subcutaneous injection (Part 2, Open-label)
Intervention Type
Drug
Intervention Name(s)
gevokizumab
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
gevokizumab open-label
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Coral Gables
State/Province
Florida
Country
United States
City
North Miami Beach
State/Province
Florida
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
New York
State/Province
New York
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Lubbock
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
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