Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01747538




Registration number
NCT01747538
Ethics application status
Date submitted
7/12/2012
Date registered
11/12/2012
Date last updated
12/07/2016

Titles & IDs
Public title
Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment
Scientific 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
Secondary ID [1] 0 0
2012-001609-25
Secondary ID [2] 0 0
X052131/CL3-78989-006
Universal Trial Number (UTN)
Trial acronym
EYEGUARD™-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uveitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Dose 1 gevokizumab
Treatment: Drugs - Dose 2 gevokizumab

Placebo comparator: Placebo -

Experimental: Dose 1 gevokizumab -

Experimental: Dose 2 gevokizumab -


Treatment: Drugs: Placebo
Solution for subcutaneous injection

Treatment: Drugs: Dose 1 gevokizumab
Solution for subcutaneous injection

Treatment: Drugs: Dose 2 gevokizumab
Solution for subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with an occurrence of uveitic disease through Day 168
Timepoint [1] 0 0
Day 0 through Day 168
Secondary outcome [1] 0 0
Time to first occurrence of uveitic disease
Timepoint [1] 0 0
Day 0 through Day 168

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
281
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- East Melbourne
Recruitment hospital [3] 0 0
- Nedlands
Recruitment hospital [4] 0 0
- Darlinghurst, New South Wales
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment postcode(s) [3] 0 0
- Nedlands
Recruitment postcode(s) [4] 0 0
- Darlinghurst, New South Wales
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Maine
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United States of America
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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United States of America
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Nebraska
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United States of America
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New Jersey
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United States of America
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North Carolina
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North Dakota
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Armenia
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Yerevan
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Brazil
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MG
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Brazil
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Rio de Janeiro
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Brazil
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San Paulo
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Chongqing
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China
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Hong Kong
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France
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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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Germany
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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
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Greece
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Mezourlo, Larissa
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Israel
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Jerusalem
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Israel
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Petoch Tikvah
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Israel
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Tel Aviv
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Italy
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Ancona, Marche
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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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Mexico
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Distrito Federal
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Mexico
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Mexico City
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Mexico
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Nuevo Leon
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Mexico
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Tijuana
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Poland
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Gdansk
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Poland
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Katowice
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Poland
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Lublin
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Poland
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Warszawa
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Lisboa
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Russian Federation
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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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South Africa
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Durban
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South Africa
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Johannesburg, Gauteng
Country [73] 0 0
Spain
State/province [73] 0 0
Barcelona
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Spain
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Granada
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Spain
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Madrid
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Spain
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Malaga
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Taiwan
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Taoyuan
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Taiwan
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Taïpeï City
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Tunisia
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Monastir
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Turkey
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Ankara
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Turkey
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Cerrahpasa, Istanbul
Country [82] 0 0
Turkey
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Faith, Istanbul
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Tyne and Wear
Country [84] 0 0
United Kingdom
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Bristol
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Liverpool
Country [86] 0 0
United Kingdom
State/province [86] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
XOMA (US) LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Institut de Recherches Internationales Servier
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01747538