Clinical trial NCT02318914: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pyoderma Gangrenosum
Keywords: Pyoderma Gangrenosum
Classic Pyoderma Gangrenosum
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2014-12-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers


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

Primary outcomes:
measure: Evaluation of treatment-emergent adverse events;
timeFrame: Up to 2 years
measure: Changes from baseline vital signs, physical examination results, and laboratory test results
timeFrame: Up to 2 years
measure: Changes from baseline concomitant medications use
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Oceanside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Coral Gables
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: Ann Arbor
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Benowa
country: Australia
state: Queensland
city: Woolloongabba
country: Australia
state: Queensland
city: Parkville
country: Australia
state: Victoria
city: Fremantle
country: Australia
city: St. Leonards
country: Australia
city: Sydney
country: Australia
city: Westmead
country: Australia
city: Markham
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
Study officials:
References: