Effects of Anakinra in Subjects With Autoimmune Inner Ear Disease
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
A Phase II randomized, placebo controlled study design of anakinra (Kineret) in
corticosteroid-resistant Meniere's disease (CR-MD)and corticosteroid-resistant 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.