Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL2-78989-001 / X052096
Study information
Scientific title
An open-label safety and pharmacokinetic study of gevokizumab in subjects with Behçets disease uveitis
Acronym
Study hypothesis
To evaluate the safety of gevokizumab as well the drug concentration in the blood of patients with Behçets Disease Uveitis
Ethics approval(s)
Ethics approval was obtained before recruitment of the first participants
Study design
International multicentre randomized open-label parallel group descriptive study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Behçets disease uveitis
Intervention
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
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Gevokizumab
Primary outcome measure
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 measures
1. Pharmacokinetics from baseline until the study end (serum samples)
2. Ophthalmological assessments
Overall study start date
01/02/2012
Overall study end date
01/05/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
21
Participant 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
Recruitment start date
01/02/2012
Recruitment end date
01/05/2013
Locations
Countries of recruitment
Korea, South, Tunisia, Turkey
Study participating centre
Istanbul University
Istanbul
34390
Turkey
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plan:
Summary results are published in https://clinicaltrials.servier.com.
Intention to publish date
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No |