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

This study has been terminated.
Information provided by (Responsible Party):
Servier Identifier:
First received: September 17, 2013
Last updated: October 5, 2015
Last verified: October 2015
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 Intervention Phase
Behcet's Uveitis Drug: Gevokizumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Servier:

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

Enrollment: 84
Study Start Date: November 2012
Study Completion Date: September 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

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
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Please refer to this study by its identifier: NCT01965145

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
Principal Investigator: Sung Chul LEE, Pr Severance Hospital
  More Information

Responsible Party: Servier Identifier: NCT01965145     History of Changes
Other Study ID Numbers: CL3-78989-002
2012-001125-27 ( EudraCT Number )
U1111-1135-1411 ( Other Identifier: WHO )
Study First Received: September 17, 2013
Last Updated: October 5, 2015

Additional relevant MeSH terms:
Behcet Syndrome
Uveal Diseases
Eye Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Pharmaceutical Solutions processed this record on August 21, 2017