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

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ClinicalTrials.gov Identifier: NCT01747538
Recruitment Status : Terminated
First Posted : December 11, 2012
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
XOMA (US) LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Uveitis Drug: Placebo Drug: Dose 1 gevokizumab Drug: Dose 2 gevokizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
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
Study Start Date : October 2012
Actual Primary Completion Date : June 2016


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


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


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Sponsors and Collaborators
XOMA (US) LLC
Institut de Recherches Internationales Servier

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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 Posted: December 11, 2012    Key Record Dates
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:
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Uveitis
Uveal Diseases
Eye Diseases