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