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An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers 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: NCT02315417
Recruitment Status : Terminated
First Posted : December 11, 2014
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC

Brief Summary:
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).

Condition or disease Intervention/treatment Phase
Pyoderma Gangrenosum Drug: gevokizumab Drug: Placebo Drug: gevokizumab open-label Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Study Start Date : November 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: gevokizumab
Solution for subcutaneous injection (Part 1, Group B)
Drug: gevokizumab
Placebo Comparator: Placebo
Solution for subcutaneous injection (Part 1, Group A)
Drug: Placebo
Experimental: gevokizumab open-label
Solution for subcutaneous injection (Part 2, Open-label)
Drug: gevokizumab open-label



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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:

  • 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


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): NCT02315417


Locations
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United States, Florida
Coral Gables, Florida, United States
North Miami Beach, Florida, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New Hampshire
Lebanon, New Hampshire, 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
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
Sponsors and Collaborators
XOMA (US) LLC

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Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT02315417     History of Changes
Obsolete Identifiers: NCT02366260
Other Study ID Numbers: X052172
First Posted: December 11, 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