Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment

Uveitis Clinical Trial

— EYEGUARD™-C  

Official title:

A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01747538
• Other study ID #: X052131/CL3-78989-006
• Secondary ID: 2012-001609-25U1
• Status: Terminated
• Phase: Phase 3
• First received: December 7, 2012
• Last updated: July 11, 2016
• Start date: October 2012

Study information

• Verified date: July 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 reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 281
• Est. primary completion date: June 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

• Controlled uveitic disease in both eyes

• Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy

• Effective contraceptive measures

Exclusion Criteria:

• Infectious uveitis and masquerade syndromes

• Isolated anterior uveitis

• Contraindication to mydriatics

• Active tuberculosis disease

• History of allergic or anaphylactic reactions to monoclonal antibodies

• 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,  Brazil,  Canada,  China,  France,  Germany,  Greece,  Israel,  Italy,  Mexico,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Taiwan,  Tunisia,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with an occurrence of uveitic disease through Day 168		Day 0 through Day 168	No
Secondary	Time to first occurrence of uveitic disease		Day 0 through Day 168	No