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

Pyoderma Gangrenosum Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02326740
• Other study ID #: X052173
• Status: Terminated
• Phase: Phase 3
• First received: December 22, 2014
• Last updated: April 25, 2016
• Start date: December 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A clinical diagnosis of classic pyoderma gangrenosum

• An active pyoderma gangrenosum ulcer

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pyoderma
• Pyoderma Gangrenosum

Intervention

Drug:
• gevokizumab

• Placebo

• gevokizumab open-label

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XOMA (US) LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The proportions of subjects at Day 126 with a reduction in the target ulcer area of = 75% or = 90% from baseline.		Day 126	No