A study of gevokizumab in subjects with Behçets disease uveitis

ISRCTN	ISRCTN15180871
DOI	https://doi.org/10.1186/ISRCTN15180871
Secondary identifying numbers	CL2-78989-001 / X052096

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

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

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
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	An open-label safety and pharmacokinetic study of gevokizumab in subjects with Behçets disease uveitis
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
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

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	21
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 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
Türkiye

Study participating centre

Istanbul University

Istanbul
34390
Türkiye

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Publication plan: Summary results are published in https://clinicaltrials.servier.com.
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

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