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Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis (EYEGUARD™-US)

Primary Purpose

Behcet's Disease Uveitis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Gevokizumab
Sponsored by
XOMA (US) LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behcet's Disease Uveitis focused on measuring Uveitis, Behcet's Disease Uveitis, Behcet's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Gevokizumab

Arm Description

Outcomes

Primary Outcome Measures

Time to first ocular exacerbation
Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2014
Last Updated
December 28, 2015
Sponsor
XOMA (US) LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02258867
Brief Title
Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis
Acronym
EYEGUARD™-US
Official Title
A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)

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 objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behcet's Disease Uveitis
Keywords
Uveitis, Behcet's Disease Uveitis, Behcet's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Gevokizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Gevokizumab
Intervention Description
Solution for subcutaneous injection
Primary Outcome Measure Information:
Title
Time to first ocular exacerbation
Description
Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.
Time Frame
Randomization through Day 280

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Other protocol-defined inclusion/exclusion criteria may apply
Facility Information:
City
Santa Ana
State/Province
California
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Ellsworth
State/Province
Maine
Country
United States
City
Cambridge
State/Province
Massachusetts
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Fargo
State/Province
North Dakota
Country
United States
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis

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