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

XOMA

Status and phase: Completed; Phase 2

Conditions: Pyoderma Gangrenosum

Treatments: Drug: gevokizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01882504

X052170

Details and patient eligibility

About

The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

gevokizumab

Experimental group

Description:

Solution for subcutaneous injection

Treatment:

Drug: gevokizumab