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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02318914
Recruitment Status : Terminated
First Posted : December 17, 2014
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC

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

Condition or disease Intervention/treatment Phase
Pyoderma Gangrenosum Drug: gevokizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Patients With Pyoderma Gangrenosum
Study Start Date : November 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: gevokizumab
Solution for subcutaneous injection
Drug: gevokizumab



Primary Outcome Measures :
  1. Evaluation of treatment-emergent adverse events; [ Time Frame: Up to 2 years ]
  2. Changes from baseline vital signs, physical examination results, and laboratory test results [ Time Frame: Up to 2 years ]
  3. Changes from baseline concomitant medications use [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318914


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Scottsdale, Arizona, United States
United States, California
Oceanside, California, United States
San Diego, California, United States
United States, Connecticut
Farmington, Connecticut, United States
United States, Florida
Coral Gables, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Tampa, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Macon, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Springfield, Illinois, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Nevada
Henderson, Nevada, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New York
Bronx, New York, United States
New York, New York, United States
Rochester, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Houston, Texas, United States
Lubbock, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Australia, Queensland
Benowa, Queensland, Australia
Woolloongabba, Queensland, Australia
Australia, Victoria
Parkville, Victoria, Australia
Australia
Fremantle, Australia
St. Leonards, Australia
Sydney, Australia
Westmead, Australia
Canada, Ontario
Markham, Ontario, Canada
Richmond Hill, Ontario, Canada
Sponsors and Collaborators
XOMA (US) LLC
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Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT02318914    
Other Study ID Numbers: X052171
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Keywords provided by XOMA (US) LLC:
Pyoderma Gangrenosum
Classic Pyoderma Gangrenosum
Additional relevant MeSH terms:
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Pyoderma
Pyoderma Gangrenosum
Skin Diseases
Skin Diseases, Vascular
Skin Ulcer