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

October 14, 2015 updated by: XOMA (US) LLC

An Open-Label, Non-Randomized, Single-Arm, Rollover Study to Continue Dosing of Gevokizumab in Subjects With Non Infectious Intermediate-, Posterior-, or Pan-Uveitis Patients Who Each Successfully Completed Either the X052130/CL3-78989-005 (EYEGUARD™-A) or the X052131/CL3-78989-006 (EYEGUARD™-C) Study or Who Have Controlled Ocular Inflammation After Receiving Study Drug in Study X052133 (EYEGUARD™-US)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States
      • Phoenix, Arizona, United States
    • California
      • Beverly Hills, California, United States
      • Redlands, California, United States
      • Riverside, California, United States
      • Sacramento, California, United States
      • Santa Ana, California, United States
      • Victorville, California, United States
    • Colorado
      • Golden, Colorado, United States
      • Littleton, Colorado, United States
    • Connecticut
      • Bridgeport, Connecticut, United States
    • Florida
      • Lakeland, Florida, United States
      • Tampa, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Maine
      • Ellsworth, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Cambridge, Massachusetts, United States
      • Waltham, Massachusetts, United States
    • Michigan
      • Jackson, Michigan, United States
      • Royal Oak, Michigan, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Jersey
      • Bloomfield, New Jersey, United States
      • Teaneck, New Jersey, United States
    • North Carolina
      • Belmont, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dose 2 gevokizumab
Drug: Dose 2 gevokizumab
Solution for subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment-emergent Adverse Events
Time Frame: 108 weeks
108 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XOMA (US) LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 2, 2014

First Posted (ESTIMATE)

October 8, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X052132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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