Back to resultsA Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum
Primary Purpose
Pyoderma Gangrenosum
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Xilonix
Sponsored by
About this trial
This is an interventional treatment trial for Pyoderma Gangrenosum focused on measuring Pyoderma Gangrenosum
Eligibility Criteria
Inclusion Criteria:
- Age: ≥18
- History of pyoderma gangrenosum with or without other systemic disease.
Exclusion Criteria:
- Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- Treatment with corticosteroids or cyclosporine within the last 2 weeks.
Sites / Locations
- XBiotech Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
open label-Xilonix
Arm Description
Open label-Xilonix
Outcomes
Primary Outcome Measures
Change in Physician's Wound Assessment & Patient's Global Assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT01965613
First Posted
October 15, 2013
Last Updated
January 26, 2021
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01965613
Brief Title
A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum
Official Title
A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2014 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if treatment with Xionix will improve wound healing for patients with pyoderma gangrenosum.
Detailed Description
XBiotech owned bermekimab and sponsored and completed study prior to Dec 30, 2019.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyoderma Gangrenosum
Keywords
Pyoderma Gangrenosum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open label-Xilonix
Arm Type
Experimental
Arm Description
Open label-Xilonix
Intervention Type
Biological
Intervention Name(s)
Xilonix
Intervention Description
IV
Primary Outcome Measure Information:
Title
Change in Physician's Wound Assessment & Patient's Global Assessment
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: ≥18
History of pyoderma gangrenosum with or without other systemic disease.
Exclusion Criteria:
Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
Treatment with corticosteroids or cyclosporine within the last 2 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
XBiotech Investigative Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum
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