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NCT01965613 Clinical Trial

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

Pyoderma Gangrenosum Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01965613
Other study ID # 2013-PT025
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 31, 2014
Est. completion date December 31, 2016

Study information
Verified date January 2021
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

XBiotech owned bermekimab and sponsored and completed study prior to Dec 30, 2019.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Xilonix
IV

Locations
Country Name City State
United States XBiotech Investigative Site Tallahassee Florida

Sponsors (1)
Lead Sponsor Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Physician's Wound Assessment & Patient's Global Assessment 28 days
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