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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XOMA (US) LLC
• Collaborators: Feinstein Institute for Medical Research; National Institute on Deafness and Other Communication Disorders (NIDCD)

Criteria

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