NCT01965613

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

January 31, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2.9 years

First QC Date

October 15, 2013

Last Update Submit

July 6, 2025

Conditions

Pyoderma Gangrenosum

Keywords

Pyoderma Gangrenosum

Outcome Measures

Primary Outcomes (1)

  • Change in Physician's Wound Assessment & Patient's Global Assessment

    28 days

Study Arms (1)

open label-Xilonix

EXPERIMENTAL

Open label-Xilonix

Biological: Xilonix

Interventions

XilonixBIOLOGICAL

IV

open label-Xilonix

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
  • Treatment with corticosteroids or cyclosporine within the last 2 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

XBiotech Investigative Site

Tallahassee, Florida, 32308, United States

Location

MeSH Terms

Conditions

Pyoderma Gangrenosum

Interventions

bermekimab

Condition Hierarchy (Ancestors)

PyodermaSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularSkin Ulcer

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 18, 2013

Study Start

January 31, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations

US(1)