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TerminatedNCT02258867EYEGUARD™-USUpdated Dec 29, 2015

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

A Phase 3 interventional study of Placebo and Gevokizumab in Behcet's Disease Uveitis, sponsored by XOMA (US) LLC. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-29.

Sponsored by XOMA (US) LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Behcet's Disease Uveitis

Keywords

  • Uveitis
  • Behcet's Disease Uveitis
  • Behcet's Disease
03

In context

Behcet Syndrome

136 studies on the registry are indexed under Behcet Syndrome; 43 are open to participants now.

This study's enrollment of 4 is below the median of 50 across 70 interventional studies indexed under Behcet Syndrome.

Browse Behcet Syndrome studies →

Lead sponsor

XOMA (US) LLC is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
4 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    Gevokizumab

    Drug: Gevokizumab

Interventions

  • DrugPlacebo

    Solution for subcutaneous injection

  • DrugGevokizumab

    Solution for subcutaneous injection

06

What researchers measure

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.

    Time frame: Randomization through Day 280

07

Study locations

8 sites
  • Santa Ana, California, United States
  • Chicago, Illinois, United States
  • Ellsworth, Maine, United States
  • Cambridge, Massachusetts, United States
  • Royal Oak, Michigan, United States
  • Winston-Salem, North Carolina, United States
  • Fargo, North Dakota, United States
  • Houston, Texas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02258867
Lead sponsor
XOMA (US) LLC
Responsible party
Sponsor
First posted
Oct 8, 2014
Start date
Nov 2014
Primary completion
Oct 2015
Completion
Nov 2015
Last update
Dec 29, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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