Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis

NCT ID: NCT02258867

Last Updated: 2015-12-29

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

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-11-30

Brief Summary

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The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).

Detailed Description

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Conditions

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Behcet's Disease Uveitis

Keywords

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Uveitis Behcet's Disease Uveitis Behcet's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution for subcutaneous injection

Gevokizumab

Group Type EXPERIMENTAL

Gevokizumab

Intervention Type DRUG

Solution for subcutaneous injection

Interventions

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Placebo

Solution for subcutaneous injection

Intervention Type DRUG

Gevokizumab

Solution for subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease
* Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months
* Best corrected visual acuity (BCVA) \>= 20 ETDRS letters in both eyes at baseline
* Effective contraceptive measures

Exclusion Criteria

* Infectious uveitis and masquerade syndromes
* End stage ocular disease
* 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
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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Santa Ana, California, United States

Site Status

Chicago, Illinois, United States

Site Status

Ellsworth, Maine, United States

Site Status

Cambridge, Massachusetts, United States

Site Status

Royal Oak, Michigan, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Fargo, North Dakota, United States

Site Status

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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X052133

Identifier Type: -

Identifier Source: org_study_id