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NCT01882504 Clinical Trial

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

Pyoderma Gangrenosum Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01882504
Other study ID # X052170
Secondary ID
Status Completed
Phase Phase 2
First received June 17, 2013
Last updated February 2, 2016
Start date May 2013
Est. completion date October 2015

Study information
Verified date February 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 safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• gevokizumab

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
XOMA (US) LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer Day 1 through Day 84 No
See also
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