Early efficacy trial of anakinra in corticosteroid-resistant autoimmune inner ear disease.
Andrea Vambutas, Martin Lesser, Virginia Mullooly...
https://pubmed.ncbi.nlm.nih.gov/25133431Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID03587701
Effects of Anakinra (Kineret) in Adults With Corticosteroid-Resistant or Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Led by Northwell Health · Updated on 2026-04-15
57
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
S
Swedish Orphan Biovitrum
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of anakinra (Kineret) compared to placebo in patients with corticosteroid-resistant or intolerant Meniere's 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 2:1 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.
CONDITIONS
Brief Title
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Meet diagnostic criteria for autoimmune inner ear disease with active hearing deterioration in one ear
- Have sensorineural hearing loss greater than 30dB at one or more frequencies in the active ear
- Have two sequential audiograms at least 28 days apart showing stable or worsening hearing after corticosteroid therapy
- Treated with oral or intratympanic prednisone with no improvement or deemed intolerant to steroids
- Completed steroid therapy prior to enrollment
- Diagnosis of Meniere's disease with corticosteroid resistance and stable diuretics for at least 28 days before enrollment
- Fluent in English for word recognition testing
- Females of childbearing potential must use effective birth control 2 months before and after treatment
- Males must use effective birth control 2 months before and after treatment
You will not qualify if you...
- Evidence of retrocochlear pathology or inner ear malformation based on imaging
- Prior treatment with gentamicin for Meniere's disease
- Hearing decline occurred more than 90 days before enrollment
- Positive test for Muckle-Wells mutation
- Currently receiving methotrexate, TNF-antagonists, or other immunosuppressive therapies
- Steroid-dependent hearing loss
- Immunodeficiency syndrome
- Active or chronic infections
- Treatment for malignancy within past 3 years
- Chronic renal insufficiency with creatinine clearance below 49mL/min
- Neutropenia before anakinra treatment
- Receipt of live vaccine within 3 months prior to enrollment
- Previous treatment with interleukin-1 antagonists
- First-degree relative with CAPS disease
- History of active narcotic abuse
- Pregnant or lactating females
- Non-English speaking patients
- Positive serology for Hepatitis B, C, HIV, or tuberculosis except for vaccination or BCG history
- History of suicidal thoughts or significant depression requiring hospitalization
- Prior participation in clinical trials using interleukin-1 inhibitors
- Known allergy to E.coli derived products
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Up to 84 days
Participants self-administer anakinra or placebo injections daily as part of two consecutive treatment periods to improve hearing thresholds.
Daily self-administration for 42 days, followed by another 42 days of daily self-administration depending on randomization
Follow-up
Duration - 264 days
Participants are observed for 264 days after treatment to monitor hearing outcomes and may have the option to retreat with anakinra if they responded to therapy.
Visits scheduled during observation period to monitor progress
Trial Site Locations
Total: 1 location
1
Northwell Health, Hearing& Speech Center
New Hyde Park, New York, United States, 11042
Actively Recruiting
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Research Team
G
Ginny Mullooly, RN
A
Andrea Vambutas, MD
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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Published Research Related To This Trial
IL-1β is overexpressed and aberrantly regulated in corticosteroid nonresponders with autoimmune inner ear disease.
Shresh Pathak, Elliot Goldofsky, Esther X Vivas...
https://pubmed.ncbi.nlm.nih.gov/21199898