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

Phase 2

Completed

• Conditions: Pyoderma Gangrenosum
• Interventions: Drug: gevokizumab

• Registration Number: NCT01882504
• Lead Sponsor: XOMA (US) LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-20
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gevokizumab	gevokizumab	Solution for subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer	Day 1 through Day 84