Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis

NCT01684345 | Terminated Phase 3

• 2 other identifiers: X052130/CL3-78989-0052012-001610-42
• Study Type: interventional
• Target: 200
• Locations: 19 countries
• Sites: 110

Brief Summary

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

Conditions

Uveitis

Keywords

Uveitis; Non-infectious Uveitis; Intermediate Uveitis; Posterior Uveitis; Panuveitis

Outcome Measures

Primary Outcomes (1)

• The proportion of responders at Day 56

  A response is defined as an improvement of the study eye without deterioration in the contralateral eye.

  Day 56

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Dose 1 gevokizumab

EXPERIMENTAL

Drug: Dose 1 gevokizumab

Dose 2 gevokizumab

EXPERIMENTAL

Drug: Dose 2 gevokizumab

Interventions

Placebo DRUG

Solution for subcutaneous injection

Placebo

Dose 1 gevokizumab DRUG

Solution for subcutaneous injection

Dose 1 gevokizumab

Dose 2 gevokizumab DRUG

Solution for subcutaneous injection

Dose 2 gevokizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• XOMA (US) LLC: lead
• Institut de Recherches Internationales Servier: collaborator

Study Sites (116)

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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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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Golden, Colorado, United States

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Littleton, Colorado, United States

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Bridgeport, Connecticut, United States

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Washington D.C., District of Columbia, United States

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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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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Ellsworth, Maine, United States

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Baltimore, Maryland, United States

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Cambridge, Massachusetts, United States

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Waltham, Massachusetts, United States

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Detroit, Michigan, United States

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Royal Oak, Michigan, United States

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Rochester, Minnesota, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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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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New York, New York, United States

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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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Fargo, North Dakota, United States

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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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Ashland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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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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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Olivos, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, Argentina

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Yerevan, Armenia

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Sydney, New South Wales, Australia

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East Melbourne, Victoria, Australia

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Nedlands, Western Australia, Australia

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Darlinghurst, New South Wales, Australia

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Graz, Austria

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Salzburg, Austria

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Vienna, Austria

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Belo Horizonte, Minas Gerais, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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Beijing, China

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Chongqing, China

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Hong Kong, China

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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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Münster, 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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Distrito Federal, Mexico

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León, Mexico

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Mexico City, 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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Warsaw, Poland

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Braga, Portugal

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Coimbra, Portugal

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Lisbon, Portugal

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Khabarovsk, Russia

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Novosibirsk, Russia

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Saint Petersburg, Russia

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Durban, South Africa

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Johannesburg, Gauteng, South Africa

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Gangnam-gu, SEL, South Korea

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Jongno-gu, SEL, South Korea

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Secho-gu, SEL, South Korea

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Seodaemun-gu, SEL, South Korea

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Songpa-g, SEL, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Granada, Spain

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León, Spain

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Madrid, Spain

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Málaga, Spain

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Taïpeï City, Taiwan

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Taoyuan District, Taiwan

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Monastir, Tunisia

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Sunderland, Tyne and Wear, United Kingdom

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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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MeSH Terms

Conditions

Uveitis; Uveitis, Intermediate; Uveitis, Posterior; Panuveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 12, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2016
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

TU (2); FR (2); ZA (2); GB (4); CN (3); PT (3); KR (6); ES (5); ME (4); PL (4); DE (5); IL (3); BR (3); AR (3); GR (1); US (52); AU (3); TW (2); RU (3)