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.
Brief Title
Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment
Categories
Conditions
Uveitis
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
* 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
Inclusion 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
inclusion/
* 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
inclusion/
Gender
All
Gender Based
false
Keywords
Uveitis
Non-infectious Uveitis
Intermediate Uveitis
Posterior Uveitis
Panuveitis
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01747538
Org Class
Industry
Org Full Name
XOMA (US) LLC
Org Study Id
X052131/CL3-78989-006
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Measure
Proportion of subjects with an occurrence of uveitic disease through Day 168
Outcome Time Frame
Day 0 through Day 168
Secondary Ids
Secondary Id
2012-001609-25
Secondary Id
U1111-1135-1462
Secondary Outcomes
Outcome Time Frame
Day 0 through Day 168
Outcome Measure
Time to first occurrence of uveitic disease
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Clark Gritz
Investigator Email
dgritz@montefiore.org
Investigator Phone