Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis (EYEGUARD™-A)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by XOMA (US) LLC
Sponsor:
Collaborator:
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT01684345
First received: September 10, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.


Condition Intervention Phase
Uveitis
Drug: Placebo
Drug: Dose 1 gevokizumab
Drug: Dose 2 gevokizumab
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 Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis

Resource links provided by NLM:


Further study details as provided by XOMA (US) LLC:

Primary Outcome Measures:
  • The proportion of responders at Day 56 [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
    A response is defined as an improvement of the study eye without deterioration in the contralateral eye.


Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Solution for subcutaneous injection
Experimental: Dose 1 gevokizumab Drug: Dose 1 gevokizumab
Solution for subcutaneous injection
Experimental: Dose 2 gevokizumab Drug: Dose 2 gevokizumab
Solution for subcutaneous injection

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
  • Active uveitic disease in at least one eye
  • Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication
  • Effective contraceptive measures

Exclusion Criteria:

  • Infectious uveitis and masquerade syndromes
  • Isolated anterior uveitis
  • Contraindication to mydriatics
  • History of allergic or anaphylactic reactions to monoclonal antibodies
  • Active tuberculosis disease
  • History of recurrent infection or predisposition to infection; active ocular infection
  • Pregnant or nursing women

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: NCT01684345

Contacts
Contact: Ann Neale 510-204-7515

  Show 86 Study Locations
Sponsors and Collaborators
XOMA (US) LLC
Institut de Recherches Internationales Servier
  More Information

No publications provided

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT01684345     History of Changes
Other Study ID Numbers: X052130/CL3-78989-005, 2012-001610-42
Study First Received: September 10, 2012
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by XOMA (US) LLC:
Uveitis
Non-infectious Uveitis
Intermediate Uveitis
Posterior Uveitis
Panuveitis

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on September 18, 2014