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Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis (EYEGUARD™-US)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02258867
Recruitment Status : Terminated
First Posted : October 8, 2014
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC

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

Condition or disease Intervention/treatment Phase
Behcet's Disease Uveitis Drug: Placebo Drug: Gevokizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis
Study Start Date : November 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Solution for subcutaneous injection

Experimental: Gevokizumab Drug: Gevokizumab
Solution for subcutaneous injection




Primary Outcome Measures :
  1. Time to first ocular exacerbation [ Time Frame: Randomization through Day 280 ]
    Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258867


Locations
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United States, California
Santa Ana, California, United States
United States, Illinois
Chicago, Illinois, United States
United States, Maine
Ellsworth, Maine, United States
United States, Massachusetts
Cambridge, Massachusetts, United States
United States, Michigan
Royal Oak, Michigan, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, North Dakota
Fargo, North Dakota, United States
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
XOMA (US) LLC
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Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT02258867    
Other Study ID Numbers: X052133
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015
Keywords provided by XOMA (US) LLC:
Uveitis
Behcet's Disease Uveitis
Behcet's Disease
Additional relevant MeSH terms:
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Behcet Syndrome
Uveitis
Uveal Diseases
Eye Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular