An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum

Phase 3

Terminated

• Conditions: Pyoderma Gangrenosum
• Interventions: Drug: Placebo; Drug: gevokizumab open-label; Drug: gevokizumab

• Registration Number: NCT02326740
• Lead Sponsor: XOMA (US) LLC

Brief Summary

The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-29
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• A clinical diagnosis of classic pyoderma gangrenosum
• An active pyoderma gangrenosum ulcer
• Contraceptive measures adequate to prevent pregnancy during the study

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Solution for subcutaneous injection (Part 1, Group A)
gevokizumab open-label	gevokizumab open-label	Solution for subcutaneous injection (Part 2, Open-label)
gevokizumab	gevokizumab	Solution for subcutaneous injection (Part 1, Group B)

Primary Outcome Measures

Name	Time	Method
The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment	Day 126

Secondary Outcome Measures

Name	Time	Method
The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.	Day 126