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Proof of Concept Study of Gevokizumab in the Treatment of 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: NCT01882504
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC

Brief Summary:
The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.

Condition or disease Intervention/treatment Phase
Pyoderma Gangrenosum Drug: gevokizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Proof of Concept Study of Gevokizumab in the Treatment of the Acute, Inflammatory Phase of Pyoderma Gangrenosum
Study Start Date : May 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer [ Time Frame: Day 1 through Day 84 ]


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:

  • 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


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): NCT01882504


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Florida
Miami Shores, Florida, United States
Miami, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, New Jersey
Verona, New Jersey, United States
United States, New York
New York, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
XOMA (US) LLC

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Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT01882504     History of Changes
Other Study ID Numbers: X052170
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016

Keywords provided by XOMA (US) LLC:
Pyoderma Gangrenosum
Classic Pyoderma Gangrenosum
Atypical Pyoderma Gangrenosum
Peristomal Pyoderma Gangrenosum

Additional relevant MeSH terms:
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Pyoderma
Pyoderma Gangrenosum
Skin Diseases
Skin Diseases, Vascular
Skin Ulcer