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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02258854
Other study ID # X052132
Secondary ID
Status Terminated
Phase Phase 3
First received October 2, 2014
Last updated October 14, 2015
Start date March 2014
Est. completion date December 2017

Study information

Verified date October 2015
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 provide continued dosing of gevokizumab in order to obtain and assess long-term gevokizumab safety data.


Recruitment information / eligibility

Status Terminated
Enrollment 69
Est. completion date December 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Completed either the X052130/CL3-78989-005 or the X052131/CL3-78989-006 study's masked D392 or OL-224 completion day visits or had controlled ocular inflammation after having received study drug in Part 2 of study X052133

Exclusion Criteria:

- Discontinued from the previous study

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dose 2 gevokizumab
Solution for subcutaneous injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
XOMA (US) LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment-emergent Adverse Events 108 weeks No
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