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

Phase 2

Completed

• Conditions: Pyoderma Gangrenosum
• Interventions: Biological: Xilonix

• Registration Number: NCT01965613
• Lead Sponsor: Janssen Research & Development, LLC

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.

Study Timeline

• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-18
• Study Start: 2014-01-31
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Disposition First Submitted: 2021-01-26
• Disposition First Submitted QC: 2021-01-26
• Disposition First Posted: 2021-01-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open label-Xilonix	Xilonix	Open label-Xilonix

Primary Outcome Measures

Name	Time	Method
Change in Physician's Wound Assessment & Patient's Global Assessment	28 days

Trial Locations

Locations (1)

XBiotech Investigative Site; 🇺🇸 Tallahassee, Florida, United States