Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum

The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.

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Key information

Conditions

Pyoderma Gangrenosum Pyoderma Skin Diseases Skin Diseases, Vascular Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

An established diagnosis of pyoderma gangrenosum
Currently experiencing an inflammatory episode of pyoderma gangrenosum
Contraceptive measures adequate to prevent pregnancy during the study

Exclusion criteria

Clinical evidence of acutely infected pyoderma gangrenosum
History of allergic or anaphylactic reactions to monoclonal antibodies
History of recurrent or chronic systemic infections
Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

gevokizumab

Drug

Primary outcomes

Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer

Time frame: Day 1 through Day 84

Sponsors and collaborators

Lead sponsor

XOMA (US) LLC

Industry

Registry information

Official study title

An Open-label, Proof of Concept Study of Gevokizumab in the Treatment of the Acute, Inflammatory Phase of Pyoderma Gangrenosum

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jun 20, 2013
Registry last updated: Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed