Clinical trial NCT02258854: An Open-label, Rollover Study Providing Continued Dosing of Gevokizumab in Order to Assess Long-term Gevokizumab Safety Data
Official title: An Open-Label, Non-Randomized, Single-Arm, Rollover Study to Continue Dosing of Gevokizumab in Subjects With Non Infectious Intermediate-, Posterior-, or Pan-Uveitis Patients Who Each Successfully Completed Either the X052130/CL3-78989-005 (EYEGUARD™-A) or the X052131/CL3-78989-006 (EYEGUARD™-C) Study or Who Have Controlled Ocular Inflammation After Receiving Study Drug in Study X052133 (EYEGUARD™-US)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uveitis
Keywords: Uveitis
Non-infectious Uveitis
Intermediate Uveitis
Posterior Uveitis
Panuveitis
Behçet's disease uveitis
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2014-10-08
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide continued dosing of gevokizumab in order to obtain and assess long-term gevokizumab safety data.


Eligibility criteria: Inclusion Criteria:

* Completed either the X052130/CL3-78989-005 or the X052131/CL3-78989-006 study's masked D392 or OL-224 completion day visits or had controlled ocular inflammation after having received study drug in Part 2 of study X052133

Exclusion Criteria:

* Discontinued from the previous study

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Treatment-emergent Adverse Events
timeFrame: 108 weeks
Secondary outcomes:
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: Redlands
country: United States
state: California
city: Riverside
country: United States
state: California
city: Sacramento
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: Lakeland
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
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: Jackson
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Bloomfield
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: Dallas
country: United States
state: Texas
city: Houston
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
Study officials:
References: