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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02318914

Enrollment

Registered

2014-12-17

Start date

2014-11-30

Completion date

2016-02-29

Last updated

2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyoderma Gangrenosum

Keywords

Pyoderma Gangrenosum, Classic Pyoderma Gangrenosum

Brief summary

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

Interventions

DRUGgevokizumab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

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

Countries

Australia, Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026