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

An Open-label Study of the Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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