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

NCT ID: NCT01965613

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Pyoderma Gangrenosum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open label-Xilonix

Open label-Xilonix

Group Type EXPERIMENTAL

Xilonix

Intervention Type BIOLOGICAL

IV

Interventions

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Xilonix

IV

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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XBiotech Investigative Site

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2013-PT025

Identifier Type: -

Identifier Source: org_study_id

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