An Open-label, Rollover Study Providing Continued Dosing of Gevokizumab in Order to Assess Long-term Gevokizumab Safety Data
EYEGUARD™-E
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)
1 other identifier
interventional
69
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2014
Typical duration for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 16, 2015
October 1, 2015
3.6 years
October 2, 2014
October 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment-emergent Adverse Events
108 weeks
Study Arms (1)
Dose 2 gevokizumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Discontinued from the previous study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XOMA (US) LLClead
Study Sites (33)
Unknown Facility
Chandler, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Redlands, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Santa Ana, California, United States
Unknown Facility
Victorville, California, United States
Unknown Facility
Golden, Colorado, United States
Unknown Facility
Littleton, Colorado, United States
Unknown Facility
Bridgeport, Connecticut, United States
Unknown Facility
Lakeland, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Ellsworth, Maine, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Cambridge, Massachusetts, United States
Unknown Facility
Waltham, Massachusetts, United States
Unknown Facility
Jackson, Michigan, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Bloomfield, New Jersey, United States
Unknown Facility
Teaneck, New Jersey, United States
Unknown Facility
Belmont, North Carolina, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Fargo, North Dakota, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 8, 2014
Study Start
March 1, 2014
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
October 16, 2015
Record last verified: 2015-10