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

XOMA

Status and phase: Terminated; Phase 3

Conditions: Pyoderma Gangrenosum

Treatments: Drug: gevokizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02318914

X052171

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

gevokizumab

Experimental group

Description:

Solution for subcutaneous injection

Treatment:

Drug: gevokizumab