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

Primary Purpose

Uveitis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Dose 1 gevokizumab
Dose 2 gevokizumab
Sponsored by
XOMA (US) LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis focused on measuring Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Dose 1 gevokizumab

Dose 2 gevokizumab

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects with an occurrence of uveitic disease through Day 168

Secondary Outcome Measures

Time to first occurrence of uveitic disease

Full Information

First Posted
December 7, 2012
Last Updated
July 11, 2016
Sponsor
XOMA (US) LLC
Collaborators
Institut de Recherches Internationales Servier
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1. Study Identification

Unique Protocol Identification Number
NCT01747538
Brief Title
Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment
Acronym
EYEGUARD™-C
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XOMA (US) LLC
Collaborators
Institut de Recherches Internationales Servier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
Keywords
Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Dose 1 gevokizumab
Arm Type
Experimental
Arm Title
Dose 2 gevokizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Dose 1 gevokizumab
Intervention Description
Solution for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Dose 2 gevokizumab
Intervention Description
Solution for subcutaneous injection
Primary Outcome Measure Information:
Title
Proportion of subjects with an occurrence of uveitic disease through Day 168
Time Frame
Day 0 through Day 168
Secondary Outcome Measure Information:
Title
Time to first occurrence of uveitic disease
Time Frame
Day 0 through Day 168

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Chandler
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Beverly Hills
State/Province
California
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United States
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Los Angeles
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California
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United States
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Redlands
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California
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United States
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Sacramento
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California
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United States
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San Luis Obispo
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California
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United States
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Santa Ana
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California
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United States
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Victorville
State/Province
California
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United States
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Golden
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Colorado
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United States
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Littleton
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Colorado
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United States
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Bridgeport
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Connecticut
Country
United States
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Washington
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District of Columbia
Country
United States
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Lakeland
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Florida
Country
United States
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St. Petersburg
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Florida
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United States
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Tampa
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Florida
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United States
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Atlanta
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Georgia
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United States
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Chicago
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Illinois
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United States
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Indianapolis
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Indiana
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United States
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Iowa City
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Iowa
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United States
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Ellsworth
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Maine
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Baltimore
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Maryland
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United States
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Cambridge
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Massachusetts
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United States
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Waltham
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Massachusetts
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United States
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Detroit
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Michigan
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United States
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Jackson
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Michigan
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United States
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Royal Oak
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Michigan
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United States
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Rochester
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Minnesota
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United States
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St. Louis
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Missouri
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United States
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Omaha
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Nebraska
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United States
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Bloomfield
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New Jersey
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United States
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Palisades Park
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New Jersey
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United States
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Teaneck
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New Jersey
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United States
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Belmont
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North Carolina
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United States
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Charlotte
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North Carolina
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United States
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Winston-Salem
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North Carolina
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United States
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Fargo
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North Dakota
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United States
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Beachwood
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Ohio
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United States
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Cleveland
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Ohio
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United States
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Middleburg Heights
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Ashland
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United States
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Philadelphia
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Knoxville
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Memphis
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Austin
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Dallas
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Houston
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Mission
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San Antonio
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Texas
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Salt Lake City
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Utah
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Norfolk
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Virginia
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United States
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Olivos
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Buenos Aires
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Argentina
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Rosaria
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Santa Fe
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Argentina
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Buenos Aires
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Argentina
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Yerevan
Country
Armenia
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Sydney
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New South Wales
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Australia
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East Melbourne
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Victoria
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Australia
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Nedlands
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Western Australia
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Australia
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Darlinghurst, New South Wales
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Australia
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Belo Horizonte
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MG
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Brazil
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Rio de Janeiro
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Beijing
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China
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Chongqing
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China
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Lyon
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France
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Nantes
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France
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Paris
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France
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Berlin
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Germany
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Chemnitz
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Germany
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Heidelberg
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Germany
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Muenster
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Germany
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Tüebingen
Country
Germany
City
Mezourlo, Larissa
Country
Greece
City
Jerusalem
Country
Israel
City
Petoch Tikvah
Country
Israel
City
Tel Aviv
Country
Israel
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Ancona, Marche
Country
Italy
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Genova
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Italy
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Milano
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Italy
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Padova
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Italy
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Padua
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Italy
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Romagna
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Italy
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Distrito Federal
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Mexico
City
Mexico City
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Mexico
City
Nuevo Leon
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Mexico
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Tijuana
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Gdansk
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Poland
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Katowice
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Lublin
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Warszawa
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Braga
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Coimbra
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Lisboa
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Khabarovsk
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint-Petersburg
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Durban
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Johannesburg, Gauteng
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South Africa
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Barcelona
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Granada
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Madrid
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Malaga
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Taoyuan
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Taiwan
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Taïpeï City
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Taiwan
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Monastir
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Tunisia
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Ankara
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Cerrahpasa, Istanbul
Country
Turkey
City
Faith, Istanbul
Country
Turkey
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Sunderland
State/Province
Tyne and Wear
Country
United Kingdom
City
Bristol
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment

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