Trial record 11 of 13 for:    Open Studies | "Behcet Syndrome"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Servier
Sponsor:
Information provided by (Responsible Party):
Servier
ClinicalTrials.gov Identifier:
NCT01965145
First received: September 17, 2013
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Behcet's Uveitis
Drug: Gevokizumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-masked, Placebo-controlled Study of the Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis

Resource links provided by NLM:


Further study details as provided by Servier:

Primary Outcome Measures:
  • Time to first acute ocular exacerbation [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    number of days


Estimated Enrollment: 110
Study Start Date: November 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965145

Contacts
Contact: IRIS clinicaltrials@servier.com

Locations
Korea, Republic of
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Servier
Investigators
Principal Investigator: Sung Chul LEE, Pr Yonsei University Severance Hospital
  More Information

No publications provided

Responsible Party: Servier
ClinicalTrials.gov Identifier: NCT01965145     History of Changes
Other Study ID Numbers: CL3-78989-002, 2012-001125-27, U1111-1135-1411
Study First Received: September 17, 2013
Last Updated: October 17, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Behcet Syndrome
Chorioretinitis
Uveitis
Cardiovascular Diseases
Choroid Diseases
Choroiditis
Eye Diseases
Mouth Diseases
Panuveitis
Retinal Diseases
Retinitis
Skin Diseases
Skin Diseases, Vascular
Stomatognathic Diseases
Uveal Diseases
Uveitis, Anterior
Uveitis, Posterior
Vascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on October 20, 2014