Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis (EYEGUARD™-A)

April 7, 2016 updated by: XOMA (US) LLC

A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis

The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

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

  • Argentina
      • Buenos Aires, Argentina
    • Buenos Aires
      • Olivos, Buenos Aires, Argentina
    • Santa Fe
      • Rosario, Santa Fe, Argentina
  • Armenia
      • Yerevan, Armenia
  • Australia
      • Darlinghurst, New South Wales, Australia
    • New South Wales
      • Sydney, New South Wales, Australia
    • Victoria
      • East Melbourne, Victoria, Australia
    • Western Australia
      • Nedlands, Western Australia, Australia
  • Austria
      • Graz, Austria
      • Salzburg, Austria
      • Wien, Austria
  • Brazil
      • Belo Horizonte, Minas Gerais, Brazil
      • Rio de Janeiro, Brazil
      • Sao Paulo, Brazil
  • China
      • Beijing, China
      • Chongqing, China
      • Hong Kong, China
  • France
      • Nantes, France
      • Paris, France
  • Germany
      • Berlin, Germany
      • Chemnitz, Germany
      • Heidelberg, Germany
      • Muenster, Germany
      • Tüebingen, Germany
  • Greece
      • Mezourlo, Larissa, Greece
  • Israel
      • Jerusalem, Israel
      • Petoch Tikvah, Israel
      • Tel Aviv, Israel
  • Korea, Republic of
      • Seoul, Korea, Republic of
    • SEL
      • Gangnam-gu, SEL, Korea, Republic of
      • Jongno-gu, SEL, Korea, Republic of
      • Secho-gu, SEL, Korea, Republic of
      • Seodaemun-gu, SEL, Korea, Republic of
      • Songpa-g, SEL, Korea, Republic of
  • Mexico
      • Distrito Federal, Mexico
      • Leon, Mexico
      • Mexico City, Mexico
      • Tijuana, Mexico
  • Poland
      • Gdansk, Poland
      • Katowice, Poland
      • Lublin, Poland
      • Warszawa, Poland
  • Portugal
      • Braga, Portugal
      • Coimbra, Portugal
      • Lisboa, Portugal
  • Russian Federation
      • Khabarovsk, Russian Federation
      • Novosibirsk, Russian Federation
      • Saint-Petersburg, Russian Federation
  • South Africa
      • Durban, South Africa
      • Johannesburg, Gauteng, South Africa
  • Spain
      • Barcelona, Spain
      • Granada, Spain
      • Leon, Spain
      • Madrid, Spain
      • Malaga, Spain
  • Taiwan
      • Taoyuan, Taiwan
      • Taïpeï City, Taiwan
  • Tunisia
      • Monastir, Tunisia
  • Turkey
      • Ankara, Turkey
      • Istanbul, Turkey
  • United Kingdom
      • Bristol, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
    • Tyne and Wear
      • Sunderland, Tyne and Wear, United Kingdom
  • United States
    • Arizona
      • Chandler, Arizona, United States
      • Phoenix, Arizona, United States
    • California
      • Beverly Hills, California, United States
      • Los Angeles, California, United States
      • Redlands, California, United States
      • Sacramento, California, United States
      • San Luis Obispo, California, United States
      • Santa Ana, California, United States
      • Victorville, California, United States
    • Colorado
      • Golden, Colorado, United States
      • Littleton, Colorado, United States
    • Connecticut
      • Bridgeport, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Lakeland, Florida, United States
      • St. Petersburg, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Maine
      • Ellsworth, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Cambridge, Massachusetts, United States
      • Waltham, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Royal Oak, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Jersey
      • Bloomfield, New Jersey, United States
      • Palisades Park, New Jersey, United States
      • Teaneck, New Jersey, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Belmont, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
    • Ohio
      • Beachwood, Ohio, United States
      • Cleveland, Ohio, United States
      • Middleburg Heights, Ohio, United States
    • Oregon
      • Ashland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Knoxville, Tennessee, United States
      • Memphis, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Mission, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
  • Active uveitic disease in at least one eye
  • Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication
  • Effective contraceptive measures

Exclusion Criteria:

  • Infectious uveitis and masquerade syndromes
  • Isolated anterior uveitis
  • Contraindication to mydriatics
  • History of allergic or anaphylactic reactions to monoclonal antibodies
  • Active tuberculosis disease
  • History of recurrent infection or predisposition to infection; active ocular infection
  • Pregnant or nursing women

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Solution for subcutaneous injection
Experimental: Dose 1 gevokizumab
Drug: Dose 1 gevokizumab
Solution for subcutaneous injection
Experimental: Dose 2 gevokizumab
Drug: Dose 2 gevokizumab
Solution for subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of responders at Day 56
Time Frame: Day 56
A response is defined as an improvement of the study eye without deterioration in the contralateral eye.
Day 56

Collaborators and Investigators

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

Sponsor

XOMA (US) LLC

Collaborators

Institut de Recherches Internationales Servier

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

August 1, 2012

Primary Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 10, 2012

First Submitted That Met QC Criteria

September 10, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X052130/CL3-78989-005
  • 2012-001610-42 (EudraCT Number)

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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