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CompletedNCT01965613Updated Jul 8, 2025

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

A Phase 2 interventional study of Xilonix in Pyoderma Gangrenosum, sponsored by Janssen Research & Development, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Pyoderma Gangrenosum

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Keywords

  • Pyoderma Gangrenosum
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    open label-Xilonix

    Open label-Xilonix

    Biological: Xilonix

Interventions

  • BiologicalXilonix

    IV

05

What researchers measure

Primary outcomes

  1. Change in Physician's Wound Assessment & Patient's Global Assessment

    Time frame: 28 days

06

Study locations

1 site
  • XBiotech Investigative Site
    Tallahassee, Florida 32308, United States
07

Registry details

Key details

Study ID
NCT01965613
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Oct 18, 2013
Start date
Jan 31, 2014
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016
Last update
Jul 8, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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