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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by XOMA (US) LLC
Sponsor:
Collaborator:
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT01747538
First received: December 7, 2012
Last updated: November 21, 2014
Last verified: November 2014
  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
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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first occurrence of uveitic disease [ Time Frame: Day 0 through Day 168 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: February 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
  • 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
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: NCT01747538

Contacts
Contact: Ann Neale 510-204-7515

  Show 123 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: NCT01747538     History of Changes
Other Study ID Numbers: X052131/CL3-78989-006, 2012-001609-25, U1111-1135-1462
Study First Received: December 7, 2012
Last Updated: November 21, 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:
Chorioretinitis
Uveitis
Choroid Diseases
Choroiditis
Eye Diseases
Panuveitis
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior

ClinicalTrials.gov processed this record on November 27, 2014