Actively Recruiting
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Led by Northwell Health · Updated on 2026-04-15
57
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
S
Swedish Orphan Biovitrum
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet diagnostic criteria for Autoimmune Inner Ear Disease with active worsening in one ear
- Hearing loss of greater than 30dB at one or more frequencies in the affected ear
- Two sequential audiograms at least 28 days apart showing no improvement after corticosteroid therapy
- Treated with or intolerant to oral or intratympanic prednisone without improvement
- Completed all steroid therapy including any intratympanic steroids
- Meniere's disease diagnosed by AAO criteria, corticosteroid resistant, and no new or increased diuretic use 28 days before enrollment
- Fluent in English
- Females of childbearing potential and males must use effective birth control 2 months before and after study drug
- May have other autoimmune diseases
- Capable of understanding and providing informed consent
You will not qualify if you...
- Retrocochlear pathology or inner ear malformations based on imaging
- Prior gentamicin treatment for Meniere's disease
- Hearing decline more than 90 days before enrollment
- Positive for Muckle-Wells mutation
- Receiving methotrexate, TNF-antagonists, or other immunosuppressives
- Steroid-dependent hearing loss
- Immunodeficiency syndromes
- Active or chronic infections
- Current or recent malignancy treatment within 3 years
- Chronic kidney failure or creatinine clearance below 49 mL/min
- Neutropenia before anakinra treatment
- Live vaccine received less than 3 months before enrollment
- Prior treatment with IL-1 antagonists
- First-degree relative with CAPS disease
- History of active narcotic abuse
- Pregnant or breastfeeding females
- Non-English speakers
- Positive for Hepatitis B, C, HIV, or tuberculosis except certain vaccination or BCG cases
- History of suicidal thoughts or severe depression
- Previous participation in IL-1 inhibitor clinical trials
- Known allergy to E. coli derived products
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Northwell Health, Hearing& Speech Center
New Hyde Park, New York, United States, 11042
Actively Recruiting
Research Team
G
Ginny Mullooly, RN
CONTACT
A
Andrea Vambutas, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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