Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis

A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitis EYEGUARD TM -B

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001125-27-DE

Enrollment

Registered

2012-09-12

Start date

2012-09-24

Completion date

Unknown

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behçet’s disease uveitis MedDRA version: 17.1 Level: LLT Classification code 10071139 Term: Behcet's uveitis System Organ Class: 100000004866

Interventions

Product Name: Gevokizumab Product Code: S78989 Pharmaceutical Form: Solution for injection INN or Proposed INN: gevokizumab CAS Number: 1129435-60-4 Current Sponsor code: S78989 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion 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 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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: From inclusion until the end of the core study	—

Measure

Time frame

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: From inclusion until the end of the core study

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Brazil, China, France, Germany, Greece, Hong Kong, India, Italy, Korea, Republic of, Portugal, Russian Federation, Saudi Arabia, Spain, Tunisia, Turkey, United Kingdom

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33155 72 43 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026