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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01965145 |
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Date of registration:
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17/09/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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A Randomized, Double-masked, Placebo-controlled Study of the Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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84 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01965145 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Korea, Republic of
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United Kingdom
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Contacts
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Name:
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Sung Chul LEE, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Severance Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Behcet's Uveitis
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Intervention(s)
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Drug: Placebo
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Drug: Gevokizumab
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Primary Outcome(s)
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Time to first acute ocular exacerbation
[Time Frame: up to 3 years]
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Secondary ID(s)
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U1111-1135-1411
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2012-001125-27
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CL3-78989-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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