Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment (EYEGUARD™-C)

July 11, 2016 updated by: XOMA (US) LLC

A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment

The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
281

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Rosaria, 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
  • Brazil
      • Rio de Janeiro, Brazil
      • San Paulo, Brazil
    • MG
      • Belo Horizonte, MG, Brazil
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
    • Quebec
      • Montréal, Quebec, Canada
  • China
      • Beijing, China
      • Chongqing, China
      • Hong Kong, China
  • France
      • Lyon, 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
  • Italy
      • Ancona, Marche, Italy
      • Genova, Italy
      • Milano, Italy
      • Padova, Italy
      • Padua, Italy
      • Romagna, Italy
  • Mexico
      • Distrito Federal, Mexico
      • Mexico City, Mexico
      • Nuevo Leon, 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
      • Madrid, Spain
      • Malaga, Spain
  • Taiwan
      • Taoyuan, Taiwan
      • Taïpeï City, Taiwan
  • Tunisia
      • Monastir, Tunisia
  • Turkey
      • Ankara, Turkey
      • Cerrahpasa, Istanbul, Turkey
      • Faith, 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
      • Jackson, Michigan, United States
      • Royal Oak, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, 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
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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
  • Controlled uveitic disease in both eyes
  • Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy
  • Effective contraceptive measures

Exclusion Criteria:

  • Infectious uveitis and masquerade syndromes
  • Isolated anterior uveitis
  • Contraindication to mydriatics
  • Active tuberculosis disease
  • History of allergic or anaphylactic reactions to monoclonal antibodies
  • 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects with an occurrence of uveitic disease through Day 168
Time Frame: Day 0 through Day 168
Day 0 through Day 168

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to first occurrence of uveitic disease
Time Frame: Day 0 through Day 168
Day 0 through Day 168

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
XOMA (US) LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • X052131/CL3-78989-006
  • 2012-001609-25 (EudraCT Number)
  • U1111-1135-1462 (Other Identifier: WHO)

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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