An Open-label, Rollover Study Providing Continued Dosing of Gevokizumab in Order to Assess Long-term Gevokizumab Safety Data

Phase 3

Terminated

• Conditions: Uveitis
• Interventions: Drug: Dose 2 gevokizumab

• Registration Number: NCT02258854
• Lead Sponsor: XOMA (US) LLC

Brief Summary

The purpose of this study is to provide continued dosing of gevokizumab in order to obtain and assess long-term gevokizumab safety data.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-16
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Completed either the X052130/CL3-78989-005 or the X052131/CL3-78989-006 study's masked D392 or OL-224 completion day visits or had controlled ocular inflammation after having received study drug in Part 2 of study X052133

Exclusion Criteria

• Discontinued from the previous study

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose 2 gevokizumab	Dose 2 gevokizumab	-

Primary Outcome Measures

Name	Time	Method
Treatment-emergent Adverse Events	108 weeks