Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis
EYEGUARD™-US
A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis
1 other identifier
interventional
4
1 country
8
Brief Summary
The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).
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 Nov 2014
Shorter than P25 for phase_3
8 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
First Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 8, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 29, 2015
December 1, 2015
11 months
October 2, 2014
December 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first ocular exacerbation
Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.
Randomization through Day 280
Study Arms (2)
Placebo
PLACEBO COMPARATORGevokizumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease
- Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months
- Best corrected visual acuity (BCVA) \>= 20 ETDRS letters in both eyes at baseline
- Effective contraceptive measures
You may not qualify if:
- Infectious uveitis and masquerade syndromes
- End stage ocular disease
- History of allergic or anaphylactic reactions to monoclonal antibodies
- Active tuberculosis disease
- History of recurrent infection or predisposition to infection; active ocular infection
- Pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XOMA (US) LLClead
Study Sites (8)
Unknown Facility
Santa Ana, California, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Ellsworth, Maine, United States
Unknown Facility
Cambridge, Massachusetts, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Fargo, North Dakota, United States
Unknown Facility
Houston, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 8, 2014
Study Start
November 1, 2014
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
December 29, 2015
Record last verified: 2015-12