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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01684345
Other study ID # X052130/CL3-78989-005
Secondary ID 2012-001610-42
Status Terminated
Phase Phase 3
First received September 10, 2012
Last updated April 7, 2016
Start date August 2012

Study information

Verified date April 2016
Source XOMA (US) LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 200
Est. completion date
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Solution for subcutaneous injection
Dose 1 gevokizumab
Solution for subcutaneous injection
Dose 2 gevokizumab
Solution for subcutaneous injection

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
XOMA (US) LLC Institut de Recherches Internationales Servier

Countries where clinical trial is conducted

United States,  Argentina,  Armenia,  Australia,  Austria,  Brazil,  China,  France,  Germany,  Greece,  Israel,  Korea, Republic of,  Mexico,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Taiwan,  Tunisia,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of responders at Day 56 A response is defined as an improvement of the study eye without deterioration in the contralateral eye. Day 56 No
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