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

• Register: EUCTR
• Last refreshed on: 19 December 2016
• Main ID: EUCTR2012-001125-27-PT
• Date of registration: 13/09/2012
• Prospective Registration: Yes
• Primary sponsor: Institut de Recherches Internationales Servier
• Public title: Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis
• Scientific title: 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
• Date of first enrolment: 04/01/2013
• Target sample size: 44
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001125-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Event driven design (core study) + open label (part2) If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical Studies Department
• Affiliation: Institut de Recherches Internationales Servier

• Name: Clinical Studies Department
• Affiliation: Institut de Recherches Internationales Servier

Key inclusion & exclusion 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:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Behçet’s disease uveitis
MedDRA version: 18.0 Level: LLT Classification code 10071139 Term: Behcet's uveitis System Organ Class: 100000004866

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

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: XOMA 052
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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

Secondary Outcome(s)

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.

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,...)

Secondary ID(s)

2012-001125-27-GB

CL3-78989-002

Source(s) of Monetary Support

ADIR

Servier Research and Development Ltd

Laboratorios Servier, S.L