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Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment (EYEGUARD™-C)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747538
First Posted: December 11, 2012
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
XOMA (US) LLC
  Purpose
The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.

Condition Intervention Phase
Uveitis Drug: Placebo Drug: Dose 1 gevokizumab Drug: Dose 2 gevokizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of subjects with an occurrence of uveitic disease through Day 168 [ Time Frame: Day 0 through Day 168 ]

Secondary Outcome Measures:
  • Time to first occurrence of uveitic disease [ Time Frame: Day 0 through Day 168 ]

Enrollment: 281
Study Start Date: October 2012
Primary Completion Date: June 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
  • Controlled uveitic disease in both eyes
  • Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy
  • Effective contraceptive measures

Exclusion Criteria:

  • Infectious uveitis and masquerade syndromes
  • Isolated anterior uveitis
  • Contraindication to mydriatics
  • Active tuberculosis disease
  • History of allergic or anaphylactic reactions to monoclonal antibodies
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747538


  Show 115 Study Locations
Sponsors and Collaborators
XOMA (US) LLC
Institut de Recherches Internationales Servier
  More Information

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT01747538     History of Changes
Other Study ID Numbers: X052131/CL3-78989-006
2012-001609-25 ( EudraCT Number )
U1111-1135-1462 ( Other Identifier: WHO )
First Submitted: December 7, 2012
First Posted: December 11, 2012
Last Update Posted: July 12, 2016
Last Verified: July 2016

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

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases