A Phase II Placebo Controlled Study of the Effects of Anakinra (Kineret) in Subjects With Corticosteroid-Resistant/Intolerant Meniere's Disease (CR-MD) and Corticosteroid-Resistant/Intolerant Autoimmune Inner Ear Disease Disease (CR-AIED)
Northwell Health
Summary
A Phase II randomized, placebo controlled study design of anakinra (Kineret) in corticosteroid-resistant or intolerant Meniere's disease (CR-MD)and corticosteroid-resistant or intolerant autoimmune inner ear disease (CR-AIED) patients. Patients will be randomized by a 2:1 allocation to anakinra or placebo for 42 continuous days. After day 42, a second placebo-controlled period will begin for an additional 42 days. This will be followed by a 264 day observation period, during which, hearing declines may be re-treated with anakinra after 30 days following the initial drug.
Description
This study will be evaluating whether or not anakinra (kineret) is superior to placebo for improving sustained hearing thresholds in patients with CR or intolerant MD and CR or intolerant AIED. Final enrollment is contingent on an acute decline in hearing in the active ear and 2 sequential audiograms greater than or equal to 28 days apart that shows a stable or declining hearing threshold and word recognition score not improved with corticosteroid therapy. Any patient that attempted to be treated with steroid therapy and was deemed intolerant will also be considered for the trial. Anakinra (ki…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * meet diagnostic criteria for Autoimmune Inner Ear Disease (AIED) with active deterioration in one ear as defined below * SNHL of greater than 30dB at one or more frequencies in the active ear. The contralateral ear may have any hearing threshold that is either stable or worsening, but may not exhibit improvement in response to corticosteroids even if the more active ear declines. Active deterioration is defined as a 15dB decline at one frequency (excluding 250 or 8kHz as a sole indicator) on their audiogram, or 10dB at 2+ frequencies developing in \> or equal 3 days but…
Interventions
- DrugAnakinra 100Mg/0.67Ml Inj Syringe (Period 1)
pre-filled syringes of anakinra 100mg/0.67mg will be provided and will be self-administered by patients daily during first 42 days of treatment (Period 1)
- DrugPlacebo injection (Period 1)
pre-filled matching placebo injections will be provided and will be self-administered by patients daily during first 42 days of treatment (Period 1)
- DrugAnakinra 100Mg/0.67Ml Inj Syringe (Period 2)
pre-filled syringes of anakinra 100mg/0.67mg will be provided and will be self-administered by patients daily during next 42 days of treatment (Period 2)
- DrugPlacebo injection (Period 2)
pre-filled matching placebo injections will be provided and will be self-administered by patients daily during next 42 days of treatment (Period 2)
Location
- Northwell Health, Hearing& Speech CenterNew Hyde Park, New York