Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B) (EYEGUARD™-B)

January 2, 2020 updated by: Institut de Recherches Internationales Servier

A Randomized, Double-masked, Placebo-controlled Study of the Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gevokizumab
Solution for subcutaneous injection, Dose 1
Drug: Gevokizumab
Sterile solution administered subcutaneously
PLACEBO_COMPARATOR: Placebo
Solution for subcutaneous injection, placebo
Drug: Placebo
Sterile solution administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first acute ocular exacerbation
Time Frame: up to 3 years
number of days
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherches Internationales Servier

Investigators

  • Principal Investigator: Sung Chul LEE, Pr, Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (ESTIMATE)

October 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 2, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL3-78989-002
  • 2012-001125-27 (EUDRACT_NUMBER)
  • U1111-1135-1411 (OTHER: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After Marketing Authorisation in EEA or US if the study is used for the approval.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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