A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum

Pyoderma Gangrenosum Clinical Trial

Official title:

A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Patients With Pyoderma Gangrenosum

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02318914
• Other study ID #: X052171
• Status: Terminated
• Phase: Phase 3
• First received: December 8, 2014
• Last updated: April 25, 2016
• Start date: November 2014
• Est. completion date: February 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 Administration
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals who participated in a previous study of gevokizumab in PG

• A clinical diagnosis of classic 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pyoderma
• Pyoderma Gangrenosum

Intervention

Drug:
• gevokizumab

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	Evaluation of treatment-emergent adverse events;		Up to 2 years	Yes
Primary	Changes from baseline vital signs, physical examination results, and laboratory test results		Up to 2 years	Yes
Primary	Changes from baseline concomitant medications use		Up to 2 years	Yes