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A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum

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ClinicalTrials.gov Identifier: NCT01965613
Recruitment Status : Completed
First Posted : October 18, 2013
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.

Brief Summary:
The purpose of this study is to determine if treatment with Xionix will improve wound healing for patients with pyoderma gangrenosum.

Condition or disease Intervention/treatment Phase
Pyoderma Gangrenosum Biological: Xilonix Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum
Study Start Date : January 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: open label-Xilonix
Open label-Xilonix
Biological: Xilonix
IV




Primary Outcome Measures :
  1. Change in Physician's Wound Assessment & Patient's Global Assessment [ Time Frame: 28 days ]


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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:

  1. Age: ≥18
  2. History of pyoderma gangrenosum with or without other systemic disease.

Exclusion Criteria:

  1. Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
  2. Treatment with corticosteroids or cyclosporine within the last 2 weeks.

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): NCT01965613


Locations
United States, Florida
XBiotech Investigative Site
Tallahassee, Florida, United States, 32308
Sponsors and Collaborators
XBiotech, Inc.

Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT01965613     History of Changes
Other Study ID Numbers: 2013-PT025
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by XBiotech, Inc.:
Pyoderma Gangrenosum

Additional relevant MeSH terms:
Pyoderma
Pyoderma Gangrenosum
Skin Diseases
Skin Diseases, Vascular
Skin Ulcer
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs