Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2018-07-13; most recent amendment 2026-04-14.
Status change: Not Yet Recruiting → Recruiting 2018-09-07
Trial Details
NCT Number NCT03587701
Lead Sponsor Northwell Health
Collaborators: Swedish Orphan Biovitrum
Conditions Autoimmune Inner Ear Disease, Meniere's Disease
Enrollment 57 participants
Start Date 2019-01-03
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-15