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

NCT ID: NCT01882504

Last Updated: 2016-02-03

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-10-31

Brief Summary

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

Detailed Description

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Conditions

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Pyoderma Gangrenosum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gevokizumab

Solution for subcutaneous injection

Group Type EXPERIMENTAL

gevokizumab

Intervention Type DRUG

Interventions

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gevokizumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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XOMA (US) LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Birmingham, Alabama, United States

Site Status

Miami, Florida, United States

Site Status

Miami Shores, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Baltimore, Maryland, United States

Site Status

Ann Arbor, Michigan, United States

Site Status

Minneapolis, Minnesota, United States

Site Status

Verona, New Jersey, United States

Site Status

New York, New York, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Cleveland, Ohio, United States

Site Status

Columbus, Ohio, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Knoxville, Tennessee, United States

Site Status

Arlington, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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X052170

Identifier Type: -

Identifier Source: org_study_id

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