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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Pyoderma Gangrenosum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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gevokizumab

Solution for subcutaneous injection (Part 1, Group B)

Group Type EXPERIMENTAL

gevokizumab

Intervention Type DRUG

Placebo

Solution for subcutaneous injection (Part 1, Group A)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

gevokizumab open-label

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

Group Type EXPERIMENTAL

gevokizumab open-label

Intervention Type DRUG

Interventions

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gevokizumab

Intervention Type DRUG

Placebo

Intervention Type DRUG

gevokizumab open-label

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No