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

April 25, 2016 updated by: XOMA (US) LLC

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Fremantle, Australia
      • St. Leonards, Australia
      • Sydney, Australia
      • Westmead, Australia
    • Queensland
      • Benowa, Queensland, Australia
      • Woolloongabba, Queensland, Australia
    • Victoria
      • Parkville, Victoria, Australia
  • Canada
    • Ontario
      • Markham, Ontario, Canada
      • Richmond Hill, Ontario, Canada
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Scottsdale, Arizona, United States
    • California
      • Oceanside, California, United States
      • San Diego, California, United States
    • Connecticut
      • Farmington, Connecticut, United States
    • Florida
      • Coral Gables, Florida, United States
      • Miami, Florida, United States
      • North Miami Beach, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Macon, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Springfield, Illinois, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Nevada
      • Henderson, Nevada, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New York
      • Bronx, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Texas
      • Houston, Texas, United States
      • Lubbock, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gevokizumab
Solution for subcutaneous injection
Drug: gevokizumab

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XOMA (US) LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X052171

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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