- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01747538
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
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
281
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
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Buenos Aires, Argentina
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Buenos Aires
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Olivos, Buenos Aires, Argentina
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Santa Fe
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Rosaria, Santa Fe, Argentina
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Yerevan, Armenia
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Darlinghurst, New South Wales, Australia
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New South Wales
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Sydney, New South Wales, Australia
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Victoria
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East Melbourne, Victoria, Australia
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Western Australia
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Nedlands, Western Australia, Australia
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Rio de Janeiro, Brazil
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San Paulo, Brazil
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MG
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Belo Horizonte, MG, Brazil
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Ontario
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Ottawa, Ontario, Canada
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Quebec
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Montréal, Quebec, Canada
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Beijing, China
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Chongqing, China
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Hong Kong, China
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Lyon, France
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Nantes, France
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Paris, France
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Berlin, Germany
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Chemnitz, Germany
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Heidelberg, Germany
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Muenster, Germany
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Tüebingen, Germany
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Mezourlo, Larissa, Greece
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Jerusalem, Israel
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Petoch Tikvah, Israel
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Tel Aviv, Israel
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Ancona, Marche, Italy
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Genova, Italy
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Milano, Italy
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Padova, Italy
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Padua, Italy
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Romagna, Italy
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Distrito Federal, Mexico
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Mexico City, Mexico
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Nuevo Leon, Mexico
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Tijuana, Mexico
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Gdansk, Poland
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Katowice, Poland
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Lublin, Poland
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Warszawa, Poland
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Braga, Portugal
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Coimbra, Portugal
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Lisboa, Portugal
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Khabarovsk, Russian Federation
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Novosibirsk, Russian Federation
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Saint-Petersburg, Russian Federation
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Durban, South Africa
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Johannesburg, Gauteng, South Africa
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Barcelona, Spain
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Granada, Spain
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Madrid, Spain
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Malaga, Spain
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Taoyuan, Taiwan
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Taïpeï City, Taiwan
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Monastir, Tunisia
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Ankara, Turkey
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Cerrahpasa, Istanbul, Turkey
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Faith, Istanbul, Turkey
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Bristol, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Tyne and Wear
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Sunderland, Tyne and Wear, United Kingdom
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Arizona
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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California
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Beverly Hills, California, United States
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Los Angeles, California, United States
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Redlands, California, United States
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Sacramento, California, United States
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San Luis Obispo, California, United States
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Santa Ana, California, United States
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Victorville, California, United States
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Colorado
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Golden, Colorado, United States
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Littleton, Colorado, United States
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Connecticut
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Bridgeport, Connecticut, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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Lakeland, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Illinois
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Chicago, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Iowa
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Iowa City, Iowa, United States
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Maine
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Ellsworth, Maine, United States
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Maryland
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Baltimore, Maryland, United States
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Massachusetts
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Cambridge, Massachusetts, United States
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Waltham, Massachusetts, United States
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Michigan
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Detroit, Michigan, United States
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Jackson, Michigan, United States
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Royal Oak, Michigan, United States
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Minnesota
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Rochester, Minnesota, United States
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Missouri
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St. Louis, Missouri, United States
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Nebraska
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Omaha, Nebraska, United States
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New Jersey
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Bloomfield, New Jersey, United States
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Palisades Park, New Jersey, United States
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Teaneck, New Jersey, United States
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North Carolina
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Belmont, North Carolina, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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North Dakota
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Fargo, North Dakota, United States
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Ohio
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Beachwood, Ohio, United States
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Cleveland, Ohio, United States
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Middleburg Heights, Ohio, United States
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Oregon
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Ashland, Oregon, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Tennessee
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Texas
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Mission, Texas, United States
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San Antonio, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Virginia
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Norfolk, Virginia, United States
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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
16 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 |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Solution for subcutaneous injection
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Experimental: Dose 1 gevokizumab
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Solution for subcutaneous injection
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Experimental: Dose 2 gevokizumab
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Solution for subcutaneous injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Proportion of subjects with an occurrence of uveitic disease through Day 168
Time Frame: Day 0 through Day 168
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Day 0 through Day 168
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Time to first occurrence of uveitic disease
Time Frame: Day 0 through Day 168
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Day 0 through Day 168
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
October 1, 2012
Primary Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
December 7, 2012
First Submitted That Met QC Criteria
December 7, 2012
First Posted (Estimate)
December 11, 2012
Study Record Updates
Last Update Posted (Estimate)
July 12, 2016
Last Update Submitted That Met QC Criteria
July 11, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Uveitis
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Priovant Therapeutics, Inc.Active, not recruitingNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious Pan UveitisUnited States
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University of NebraskaUnknownPosterior Uveitis | Intermediate Uveitis | Pan-uveitisUnited States
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Stanford UniversitySanten Inc.WithdrawnPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
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CHU de Quebec-Universite LavalCompletedIntermediate Uveitis | Anterior UveitisCanada
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EyePoint Pharmaceuticals, Inc.CompletedPanuveitis | Posterior Uveitis | Intermediate UveitisIndia
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Johns Hopkins UniversityMacuSight, Inc.CompletedPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
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Novartis PharmaceuticalsCompletedNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious PanuveitisUnited States, United Kingdom
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Duke UniversityCompletedPosterior Uveitis | Intermediate UveitisUnited States
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AllerganCompletedPosterior Uveitis | Intermediate UveitisFrance, United Kingdom, United States, Spain, Poland, India, South Africa, Korea, Republic of, Canada, Czech Republic, Australia, Germany, Israel, Switzerland, Portugal, Austria, Brazil, Greece
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The New York Eye & Ear InfirmaryUnknownPanuveitis | Uveitis | Posterior Uveitis | Anterior UveitisUnited States
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States