Clinical trial NCT01747538: Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uveitis
Keywords: Uveitis
Non-infectious Uveitis
Intermediate Uveitis
Posterior Uveitis
Panuveitis
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
Collaborators: name: Institut de Recherches Internationales Servier
First posted: 2012-12-11
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects with an occurrence of uveitic disease through Day 168
timeFrame: Day 0 through Day 168
Secondary outcomes:
measure: Time to first occurrence of uveitic disease
timeFrame: Day 0 through Day 168
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Redlands
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Victorville
country: United States
state: California
city: Golden
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Lakeland
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Ellsworth
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Cambridge
country: United States
state: Massachusetts
city: Waltham
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Jackson
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Bloomfield
country: United States
state: New Jersey
city: Palisades Park
country: United States
state: New Jersey
city: Teaneck
country: United States
state: New Jersey
city: Belmont
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Beachwood
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Ashland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Mission
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Olivos
country: Argentina
state: Buenos Aires
city: Rosaria
country: Argentina
state: Santa Fe
city: Buenos Aires
country: Argentina
city: Yerevan
country: Armenia
city: Sydney
country: Australia
state: New South Wales
city: East Melbourne
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Darlinghurst, New South Wales
country: Australia
city: Belo Horizonte
country: Brazil
state: MG
city: Rio de Janeiro
country: Brazil
city: San Paulo
country: Brazil
city: Ottawa
country: Canada
state: Ontario
city: Montréal
country: Canada
state: Quebec
city: Beijing
country: China
city: Chongqing
country: China
city: Hong Kong
country: China
city: Lyon
country: France
city: Nantes
country: France
city: Paris
country: France
city: Berlin
country: Germany
city: Chemnitz
country: Germany
city: Heidelberg
country: Germany
city: Muenster
country: Germany
city: Tüebingen
country: Germany
city: Mezourlo, Larissa
country: Greece
city: Jerusalem
country: Israel
city: Petoch Tikvah
country: Israel
city: Tel Aviv
country: Israel
city: Ancona, Marche
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Padua
country: Italy
city: Romagna
country: Italy
city: Distrito Federal
country: Mexico
city: Mexico City
country: Mexico
city: Nuevo Leon
country: Mexico
city: Tijuana
country: Mexico
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Lublin
country: Poland
city: Warszawa
country: Poland
city: Braga
country: Portugal
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Khabarovsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Durban
country: South Africa
city: Johannesburg, Gauteng
country: South Africa
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Taoyuan
country: Taiwan
city: Taïpeï City
country: Taiwan
city: Monastir
country: Tunisia
city: Ankara
country: Turkey
city: Cerrahpasa, Istanbul
country: Turkey
city: Faith, Istanbul
country: Turkey
city: Sunderland
country: United Kingdom
state: Tyne and Wear
city: Bristol
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
Study officials:
References: