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Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B) (EYEGUARD™-B)

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: NCT01965145
Recruitment Status : Terminated
First Posted : October 18, 2013
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis exacerbations

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

Detailed Description:
A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-masked, Placebo-controlled Study of the Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis
Study Start Date : November 2012
Primary Completion Date : July 2015
Study Completion Date : September 2015


Arms and Interventions

Arm Intervention/treatment
Experimental: Gevokizumab
Solution for subcutaneous injection, Dose 1
Drug: Gevokizumab
Sterile solution administered subcutaneously
Placebo Comparator: Placebo
Solution for subcutaneous injection, placebo
Drug: Placebo
Sterile solution administered subcutaneously


Outcome Measures

Primary Outcome Measures :
  1. Time to first acute ocular exacerbation [ Time Frame: up to 3 years ]
    number of days


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria.
  • History of Behçet's disease uveitis with ocular involvement of the posterior segment.
  • Patients with a stable background treatment of oral corticosteroid and at least one immunosuppressive drug.
  • Male or female, age ≥18 (or legal age of majority in the country) at selection
  • For subjects with reproductive potential, a willingness to use highly effective contraceptive measures

Exclusion Criteria:

  • Infectious uveitis, uveitis due to causes other than Behçet's disease.
  • Monocular vision
  • Presence of severe cataract or severe posterior capsular opacification.
  • Contraindication to mydriasis or presence of posterior synechiae.
  • Active TB disease.
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies
  • History of malignancy within 5 years prior to Selection.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

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): NCT01965145


Locations
Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
United Kingdom
St Thomas' Hospital
London, United Kingdom, SE1 5EZ
Sponsors and Collaborators
Servier
Investigators
Principal Investigator: Sung Chul LEE, Pr Severance Hospital
More Information

Additional Information:
Responsible Party: Servier
ClinicalTrials.gov Identifier: NCT01965145     History of Changes
Other Study ID Numbers: CL3-78989-002
2012-001125-27 ( EudraCT Number )
U1111-1135-1411 ( Other Identifier: WHO )
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2015

Additional relevant MeSH terms:
Uveitis
Behcet Syndrome
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
Pharmaceutical Solutions