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):
ClinicalTrials.gov 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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 ClinicalTrials.gov 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 Yonsei University Severance Hospital
  More Information

Responsible Party: Servier
ClinicalTrials.gov Identifier: NCT01965145     History of Changes
Other Study ID Numbers: CL3-78989-002  2012-001125-27  U1111-1135-1411 
Study First Received: September 17, 2013
Last Updated: October 5, 2015
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Behcet Syndrome
Cardiovascular Diseases
Eye Diseases
Genetic Diseases, Inborn
Hereditary Autoinflammatory Diseases
Mouth Diseases
Skin Diseases
Skin Diseases, Genetic
Skin Diseases, Vascular
Stomatognathic Diseases
Uveal Diseases
Uveitis, Anterior
Vascular Diseases

ClinicalTrials.gov processed this record on May 24, 2016