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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 (part of Johnson & Johnson) · 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

In context

Pyoderma Gangrenosum

36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.

This study's enrollment of 10 is close to the median of 10 across 26 interventional studies indexed under Pyoderma Gangrenosum.

Browse Pyoderma Gangrenosum studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.

Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 agents within the last 4 weeks (or 5 half-lives, whichever is longer).
  2. Treatment with or cyclosporine within the last 2 weeks.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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

06

What researchers measure

Primary outcomes

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

    Time frame: 28 days

07

Study locations

1 site
  • XBiotech Investigative Site
    Tallahassee, Florida 32308, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01965613
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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Discussion

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Studies of the drug tested here: Bermekimab

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