A study of gevokizumab in subjects with Behçet?s disease uveitis

• Register: ISRCTN
• Last refreshed on: 21 May 2018
• Main ID: ISRCTN15180871
• Date of registration: 04/04/2012
• Prospective Registration: No
• Primary sponsor: Institut de Recherches Internationales Servier (France)
• Public title: A study of gevokizumab in subjects with Behçet?s disease uveitis
• Scientific title: An open-label safety and pharmacokinetic study of gevokizumab in subjects with Behçet?s disease uveitis
• Date of first enrolment: 01/02/2012
• Target sample size: 21
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15180871
• Study type: Interventional
• Study design: International multicentre randomized open-label parallel group descriptive study (Treatment)
• Phase: Not Specified

Countries of recruitment

Korea, South, Tunisia, Turkey

Contacts

• Name: Ahmet Gul

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients with uveitis associated with Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria
2. Male or female, age [18 or legal age of majority- 80] years old
3. Stable regimen of oral corticosteroids and at least one immunosuppressive treatment
Exclusion criteria: 1. Infectious uveitis, uveitis due to causes other than Behçet's disease, or uveitis of unknown origin
2. Cataract so severe that an assessment of the posterior segment of the uvea and the fundus is inadequate or impossible
3. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Behçet?s disease uveitis
Skin and Connective Tissue Diseases
Behçet's disease

Intervention(s)

Three open treatment arms on top of stable background treatment for a one year period, with either :
Gevokizumab
1. Dose 1 intravenous (IV) followed by monthly dose 1 subcutaneous (SC), or
2. Dose 1 IV followed by dose 2 SC, or
3. Dose 2 IV followed by monthly dose 2 IV
In addition for patients with an acute ocular exacerbation at presentation, an IV injection is repeated 2 to 3 weeks later, before continuing monthly administrations

Primary Outcome(s)

Safety evaluation throughout the study
1. Adverse events
2. Vital signs
3. Laboratory values
4. Standard 12-lead electrocardiograms (ECGs) and chest X-ray at baseline and at study end

Secondary Outcome(s)

1. Pharmacokinetics from baseline until the study end (serum samples)
2. Ophthalmological assessments

Secondary ID(s)

CL2-78989-001 / X052096

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Ethics review

Status:
Approval date:
Contact:

Ethics approval was obtained before recruitment of the first participants

Results

• Results available: Yes
• Date Completed: 01/05/2013