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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Pyoderma Gangrenosum

Treatments: Biological: Xilonix

Study type: Interventional

Funder types: Industry

Identifiers

NCT01965613

2013-PT025

Details and patient eligibility

About

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

Full description

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

open label-Xilonix

Experimental group

Description:

Open label-Xilonix

Treatment:

Biological: Xilonix