The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

Completed · Phase 2

Conditions studied: Autoimmune Inner Ear Disease

In brief

The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy in patients with steroid resistant Autoimmune Inner Ear Disease.

Key facts

Study ID

NCT01950312

Run by

XOMA (US) LLC

People needed

10

Starts

2013-08-01

Expected to finish

2015-12-01

Last updated by the study team

2016-02-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Autoimmune Inner Ear Disease with active deterioration in at least one ear
• Failure to respond to a trial of high-dose corticosteroid therapy
• Contraceptive measures adequate to prevent pregnancy during the study

You may not qualify if…

• Evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct)
• History of active or chronic infections
• Currently receiving, or having received treatment for a malignancy in the past three years
• Hearing loss that coincides with significant, disabling episodes of vertigo
• History of allergic or anaphylactic reactions to monoclonal antibodies
• Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Long Island Jewish Medical Center, Hearing & Speech Center — New Hyde Park, New York, United States

Full record on ClinicalTrials.gov

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