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

XOMA

Status and phase: Terminated; Phase 3

Conditions: Pyoderma Gangrenosum

Treatments: Drug: gevokizumab open-label; Drug: gevokizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02315417

X052172

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 3 patient groups, including a placebo group

gevokizumab

Experimental group

Description:

Solution for subcutaneous injection (Part 1, Group B)

Treatment:

Drug: gevokizumab

Placebo

Placebo Comparator group

Description:

Solution for subcutaneous injection (Part 1, Group A)

Treatment:

Drug: Placebo

gevokizumab open-label

Experimental group

Description:

Solution for subcutaneous injection (Part 2, Open-label)

Treatment:

Drug: gevokizumab open-label