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A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum

Primary Purpose

Pyoderma Gangrenosum

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
gevokizumab
Sponsored by
XOMA (US) LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pyoderma Gangrenosum focused on measuring Pyoderma Gangrenosum, Classic Pyoderma Gangrenosum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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

Evaluation of treatment-emergent adverse events;
Changes from baseline vital signs, physical examination results, and laboratory test results
Changes from baseline concomitant medications use

Secondary Outcome Measures

Full Information

First Posted
December 8, 2014
Last Updated
April 25, 2016
Sponsor
XOMA (US) LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02318914
Brief Title
A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum
Official Title
A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Patients With 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
February 2016 (Actual)
Study Completion Date
February 2016 (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 long-term safety of gevokizumab in treating active PG ulcers

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (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
Evaluation of treatment-emergent adverse events;
Time Frame
Up to 2 years
Title
Changes from baseline vital signs, physical examination results, and laboratory test results
Time Frame
Up to 2 years
Title
Changes from baseline concomitant medications use
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Scottsdale
State/Province
Arizona
Country
United States
City
Oceanside
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Farmington
State/Province
Connecticut
Country
United States
City
Coral Gables
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
North Miami Beach
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Macon
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Henderson
State/Province
Nevada
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
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
City
Salt Lake City
State/Province
Utah
Country
United States
City
Benowa
State/Province
Queensland
Country
Australia
City
Woolloongabba
State/Province
Queensland
Country
Australia
City
Parkville
State/Province
Victoria
Country
Australia
City
Fremantle
Country
Australia
City
St. Leonards
Country
Australia
City
Sydney
Country
Australia
City
Westmead
Country
Australia
City
Markham
State/Province
Ontario
Country
Canada
City
Richmond Hill
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum

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