Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis

Uveitis Clinical Trial

— EYEGUARD™-A  

Official title:

A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01684345
• Other study ID #: X052130/CL3-78989-005
• Secondary ID: 2012-001610-42
• Status: Terminated
• Phase: Phase 3
• First received: September 10, 2012
• Last updated: April 7, 2016
• Start date: August 2012

Study information

• Verified date: April 2016
• 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 purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye

• Active uveitic disease in at least one eye

• Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication

• Effective contraceptive measures

Exclusion Criteria:

• Infectious uveitis and masquerade syndromes

• Isolated anterior uveitis

• Contraindication to mydriatics

• 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

• Uveitis

Intervention

Drug:
• Placebo
Solution for subcutaneous injection
• Dose 1 gevokizumab
Solution for subcutaneous injection
• Dose 2 gevokizumab
Solution for subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
XOMA (US) LLC	Institut de Recherches Internationales Servier

Countries where clinical trial is conducted

United States,  Argentina,  Armenia,  Australia,  Austria,  Brazil,  China,  France,  Germany,  Greece,  Israel,  Korea, Republic of,  Mexico,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Taiwan,  Tunisia,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of responders at Day 56	A response is defined as an improvement of the study eye without deterioration in the contralateral eye.	Day 56	No