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

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ClinicalTrials.gov Identifier: NCT01965145
Recruitment Status : Terminated
First Posted : October 18, 2013
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Servier

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 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
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015


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




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



Information from the National Library of Medicine

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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:

  • 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


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

Additional Information:
Publications of Results:
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: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: http://clinicaltrials.servier.com

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