Back to resultsAn Open-label, Rollover Study Providing Continued Dosing of Gevokizumab in Order to Assess Long-term Gevokizumab Safety Data (EYEGUARD™-E)
Primary Purpose
Uveitis
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dose 2 gevokizumab
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis focused on measuring Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis, Behçet's disease uveitis
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose 2 gevokizumab
Arm Description
Outcomes
Primary Outcome Measures
Treatment-emergent Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02258854
Brief Title
An Open-label, Rollover Study Providing Continued Dosing of Gevokizumab in Order to Assess Long-term Gevokizumab Safety Data
Acronym
EYEGUARD™-E
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
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XOMA (US) LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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, Behçet's disease uveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 2 gevokizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dose 2 gevokizumab
Intervention Description
Solution for subcutaneous injection
Primary Outcome Measure Information:
Title
Treatment-emergent Adverse Events
Time Frame
108 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Chandler
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Redlands
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
Santa Ana
State/Province
California
Country
United States
City
Victorville
State/Province
California
Country
United States
City
Golden
State/Province
Colorado
Country
United States
City
Littleton
State/Province
Colorado
Country
United States
City
Bridgeport
State/Province
Connecticut
Country
United States
City
Lakeland
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Ellsworth
State/Province
Maine
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Cambridge
State/Province
Massachusetts
Country
United States
City
Waltham
State/Province
Massachusetts
Country
United States
City
Jackson
State/Province
Michigan
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Bloomfield
State/Province
New Jersey
Country
United States
City
Teaneck
State/Province
New Jersey
Country
United States
City
Belmont
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Fargo
State/Province
North Dakota
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open-label, Rollover Study Providing Continued Dosing of Gevokizumab in Order to Assess Long-term Gevokizumab Safety Data
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