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

NCT ID: NCT02258854

Last Updated: 2015-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Uveitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose 2 gevokizumab

Group Type EXPERIMENTAL

Dose 2 gevokizumab

Intervention Type DRUG

Solution for subcutaneous injection

Interventions

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Dose 2 gevokizumab

Solution for subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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XOMA (US) LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chandler, Arizona, United States

Site Status

Phoenix, Arizona, United States

Site Status

Beverly Hills, California, United States

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Redlands, California, United States

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Riverside, California, United States

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Sacramento, California, United States

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Santa Ana, California, United States

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Victorville, California, United States

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Golden, Colorado, United States

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Littleton, Colorado, United States

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Bridgeport, Connecticut, United States

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Lakeland, Florida, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Ellsworth, Maine, United States

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Baltimore, Maryland, United States

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Cambridge, Massachusetts, United States

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Waltham, Massachusetts, United States

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Jackson, Michigan, United States

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Royal Oak, Michigan, United States

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Omaha, Nebraska, United States

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Bloomfield, New Jersey, United States

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Teaneck, New Jersey, United States

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Belmont, North Carolina, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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X052132

Identifier Type: -

Identifier Source: org_study_id

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