Phase II Study of Anakinra Kineret for Treating Corticosteroid-Resistant or Intolerant Menieres Disease and Autoimmune Inner Ear Disease

What this Trial Is About

Researchers are evaluating the effects of anakinra Kineret compared to placebo in patients with corticosteroid-resistant or intolerant Menieres disease and autoimmune inner ear disease. This Phase II randomized, placebo-controlled study aims to see if anakinra improves sustained hearing thresholds in these patients who have not responded to corticosteroid therapy. The study focuses on those with active hearing deterioration confirmed by sequential audiograms and word recognition tests. Participants will be randomly assigned in a 21 ratio to receive either anakinra or placebo injections daily for 42 days. After this, a second 42-day placebo-controlled period follows, where patients may continue anakinra or switch to placebo depending on their initial group assignment. Following these treatment periods, there is a 264-day observation phase where patients showing response may be retreated with anakinra after 30 days. During the study, participants will self-administer injections daily. Hearing will be monitored through audiograms and word recognition tests at multiple time points, including days 28 and 42. Researchers will assess sustained improvements in hearing thresholds and word recognition scores. Safety and longer-term effects will be observed during the follow-up period, with total participation lasting over 300 days.

Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease