A Phase II Open Label Study of Xilonix in Subjects With P... | NCT01965613

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

NCT01965613

Sponsor

Janssen Research & Development, LLC

Status

Completed

Last Update Posted

Jul 8, 2025Actual

Enrollment

10Actual

Phase

Phase 2

Conditions

Pyoderma Gangrenosum

Interventions

Xilonix

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2014Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

Oct 15, 2013

First Submission Date that Met QC Criteria

Oct 15, 2013

First Posted Date

Oct 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jan 26, 2021

Certification/Extension First Submitted that Passed QC Review

Jan 26, 2021

Certification/Extension First Posted Date

Jan 28, 2021Actual

Last Update Submitted Date

Jul 6, 2025

Last Update Posted Date

Jul 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
open label-Xilonix	Experimental	Open label-Xilonix	Biological: Xilonix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xilonix	Biological	IV	open label-Xilonix

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Physician's Wound Assessment & Patient's Global Assessment		28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
XBiotech Investigative Site		Tallahassee	Florida	32308	United States

Condition Browse Module

MeSH Terms

ID	Term
D017511	Pyoderma Gangrenosum

Ancestor Terms

ID	Term
D011711	Pyoderma
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017445	Skin Diseases, Vascular

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000604877	bermekimab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided