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

Phase 3

Terminated

• Conditions: Behcet's Disease Uveitis
• Interventions: Drug: Placebo; Drug: Gevokizumab

• Registration Number: NCT02258867
• Lead Sponsor: XOMA (US) LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-08
• Study Start: 2014-11
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Gevokizumab	Gevokizumab	-

Primary Outcome Measures

Name	Time	Method
Time to first ocular exacerbation	Randomization through Day 280	Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.