Efficacy of gevokizumab in the treatment of patients with Behcet`s disease uveitis

• Conditions: Behçet's disease uveitis; MedDRA version: 14.1Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 14.1Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-001125-27-IT
• Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-21
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

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 backgroud 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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. - Infectious disease. - Known immunodeficiency.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: The secondary objectives are to assess the effect of gevokizumab on the other efficacy endpoints and to evaluate its safety.;Primary end point(s): Time to first acute ocular exacerbation (number of days);Timepoint(s) of evaluation of this end point: Time to first acute ocular exacerbation (number of days).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Ocular exacerbations - Visual acuity - Vitreous haze - Retinal infiltrates or acute retinal vasculitis - Anterior chamber - Safety measurements (adverse events, non ocular manifestations of Behçet's Disease, vital signs, chest X rays, standard 12-lead ECG, laboratory parameters,...);Timepoint(s) of evaluation of this end point: Ocular exacerbations : from inclusion to the end of the trial, -Vitreous haze, retinal infiltrates, acute retinal vasculitis, anterior chamber, visual acuity : at each visit of Part 1. Part 2 : at month 4 and end of trial, -Safety measurements : from selection to the end of the trial.