NCT01965145

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Typical duration for phase_3

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 3, 2020

Status Verified

January 1, 2020

Enrollment Period

2.7 years

First QC Date

September 17, 2013

Last Update Submit

January 2, 2020

Conditions

Behcet's Uveitis

Outcome Measures

Primary Outcomes (1)

  • Time to first acute ocular exacerbation

    number of days

    up to 3 years

Study Arms (2)

Gevokizumab

EXPERIMENTAL

Solution for subcutaneous injection, Dose 1

Drug: Gevokizumab

Placebo

PLACEBO COMPARATOR

Solution for subcutaneous injection, placebo

Drug: Placebo

Interventions

GevokizumabDRUG

Sterile solution administered subcutaneously

Gevokizumab
PlaceboDRUG

Sterile solution administered subcutaneously

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 background 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yonsei University Severance Hospital

Seoul, 120-752, South Korea

Location

St Thomas' Hospital

London, SE1 5EZ, United Kingdom

Location

Related Publications (1)

  • Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-Poenaru O, Gul A. Use of Gevokizumab in Patients with Behcet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study. Ocul Immunol Inflamm. 2018;26(7):1023-1033. doi: 10.1080/09273948.2017.1421233. Epub 2018 Jan 25.

    PMID: 29370572RESULT

MeSH Terms

Interventions

gevokizumab

Study Officials

  • Sung Chul LEE, Pr

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2013

First Posted

October 18, 2013

Study Start

November 1, 2012

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

January 3, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
More information

Locations

GB(1)KR(1)