Autoimmune Inner Ear Disease
Conditions
Keywords
Autoimmune Inner Ear Disease, Inner Ear Disease, Meniere's Disease, Sudden Sensorineural Hearing Loss
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.
Interventions
DRUGgevokizumab
Sponsors
Feinstein Institute for Medical Research
National Institute on Deafness and Other Communication Disorders (NIDCD)
XOMA (US) LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed