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

Behcet's Disease Uveitis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02258867
• Other study ID #: X052133
• Status: Terminated
• Phase: Phase 3
• First received: October 2, 2014
• Last updated: December 28, 2015
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behcet Syndrome
• Behcet's Disease Uveitis
• Uveitis

Intervention

Drug:
• Placebo
Solution for subcutaneous injection
• Gevokizumab
Solution for subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XOMA (US) LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No