The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
- Registration Number
- NCT01950312
- Lead Sponsor
- XOMA (US) LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gevokizumab gevokizumab Solution for subcutaneous injection
- Primary Outcome Measures
Name Time Method 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) Day 28 to Day 84
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Long Island Jewish Medical Center, Hearing & Speech Center
🇺🇸New Hyde Park, New York, United States
Long Island Jewish Medical Center, Hearing & Speech Center🇺🇸New Hyde Park, New York, United States