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.

Full Title of Study: “An Open-label Study of the Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2015


  • Drug: gevokizumab

Arms, Groups and Cohorts

  • Experimental: gevokizumab
    • Solution for subcutaneous injection

Clinical Trial Outcome Measures

Primary Measures

  • Improved hearing threshold, as defined by an improvement in either the PTA (Pure Tone Average) of >=5 dB (Decibel), or 12% in the WRS (Word Recognition Score)
    • Time Frame: Day 28 to Day 84

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • XOMA (US) LLC
  • Collaborator
    • Feinstein Institute for Medical Research
  • Provider of Information About this Clinical Study
    • Sponsor

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