A study of gevokizumab in subjects with Behçets disease uveitis

ISRCTN	ISRCTN15180871
DOI	https://doi.org/10.1186/ISRCTN15180871
Protocol serial number	CL2-78989-001 / X052096
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 20/02/2012
Registration date: 04/04/2012
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Prof Ahmet Gul
Scientific

Istanbul University
Istanbul Faculty of Medicine
Department of Internal Medicine
Division of Rheumatology
Istanbul
34390
Türkiye

Study information

Primary study design	Interventional
Study design	International multicentre randomized open-label parallel group descriptive study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	An open-label safety and pharmacokinetic study of gevokizumab in subjects with Behçets disease uveitis
Study objectives	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
Health condition(s) or problem(s) studied	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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Gevokizumab
Primary outcome measure(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
Key secondary outcome measure(s)	1. Pharmacokinetics from baseline until the study end (serum samples) 2. Ophthalmological assessments
Completion date	01/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	21
Key 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
Key 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
Date of first enrolment	01/02/2012
Date of final enrolment	01/05/2013

Locations

Countries of recruitment

Korea, South
Tunisia
Türkiye

Study participating centre

Istanbul University

Istanbul
34390
Türkiye

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
24/01/2018: Publication plan and IPD sharing statement added.
04/12/2017: Results summary added.

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