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Anakinra for Corticosteroid-Resistant Meniere's Disease and Autoimmune Inner Ear Disease

This study is testing if the drug anakinra (Kineret) can improve hearing in people with Meniere's disease or autoimmune inner ear disease (AIED) that hasn't responded well to standard steroid treatments. You might be able to join if you are between 18 and 75 years old and have active hearing loss in one ear due to AIED, or Meniere's disease that hasn't improved with steroids. The researchers will compare anakinra to a placebo (an inactive substance) to see if anakinra leads to a sustained improvement in hearing. The study aims to enroll 57 participants, but its current status is unclear.

Study design
This is a randomized, placebo-controlled study where participants will be assigned to receive either anakinra or a placebo. There will be 57 participants in total.
What's involved
You would self-administer daily injections of anakinra or placebo for 42 days, followed by another 42-day period with anakinra or placebo. This is followed by a 264-day observation period.
Compensation
Not stated in the trial record.
Follow-up
After the initial treatment periods, there is a 264-day observation period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03587701

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Northwell Health
~57 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Anakinra 100Mg/0.67Ml Inj Syringe (Period 1)Placebo injection (Period 1)Anakinra 100Mg/0.67Ml Inj Syringe (Period 2)Placebo injection (Period 2)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sustained improvement in hearing thresholds
Measured over Hearing improvement from pre-treatment thresholds at day 28
+1 more outcome measured

Conditions

Autoimmune Inner Ear Disease
Meniere's Disease

Explore related trials

Autoimmune disorder of inner earMeniere Disease

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Andrea Vambutas, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

Ginny Mullooly, RN
[email protected]
718-470-7974
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

meet diagnostic criteria for Autoimmune Inner Ear Disease (AIED) with active deterioration in one ear as defined below
SNHL of greater than 30dB at one or more frequencies in the active ear. The contralateral ear may have any hearing threshold that is either stable or worsening, but may not exhibit improvement in response to corticosteroids even if the more active ear declines. Active deterioration is defined as a 15dB decline at one frequency (excluding 250 or 8kHz as a sole indicator) on their audiogram, or 10dB at 2+ frequencies developing in \> or equal 3 days but \< or equal 90 days, or if the hearing loss evolved in less than 3 days, the patient displayed features suggestive of an autoimmune disorder
Capable of understanding and giving informed consent
Have 2 sequential audiograms following the decline in hearing \>or equal 28 days apart with no demonstrable improvement in hearing following corticosteroid therapy (\<or equal 5dB of improvement at any individual frequency (250, 500, 1000, 2000 and 4000Hz) and \<12% improvement in WRS)
Patients must have been treated with oral or IT prednisone with no demonstrable improvement or attempted to be treated and deemed intolerant. Steroid intolerance is defined as unable or unwilling to take corticosteroids because of a prior untoward effect or a current medical condition that would negatively be impacted by steroid use
Must have completed steroid therapy, including any intratympanic steroid therapy
Meniere's disease defined according to the AAO criteria, with the additional requirement of corticosteroid resistance AND no new diuretics may be instituted or dose increased from 28 days prior to trial enrollment
Patients must be fluent in English as all word recognition scores are based on testing in English
Patients may have other autoimmune disease(s) Females of childbearing potential, must be practicing a method of birth control considered effective and medically acceptable by the investigator for a minimum of 2 months prior to the study and at least 2 months after last administration of study drug
Males similarly must be practicing a method of birth control considered effective and medically acceptable by the investigator for a minimum of 2 months prior to the study and at least 2 months after last administration of study drug

Exclusion

Evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct) based on imaging
Prior treatment with gentamicin for Meniere's Disease
Most recent decline in hearing occurring \>90 days prior to trial enrollment
Positive test for Muckle-Wells mutation
Concurrently receiving methotrexate, TNF-antagonist therapy or any other immunosuppressive therapy
Steroid-dependent hearing loss
Any immunodeficiency syndrome
Active or chronic infections
Currently receiving, or having received treatment for a malignancy in the past 3 years
Chronic renal insufficiency (a creatinine clearance of \<49mL/min) or chronic renal failure
Neutropenia prior to treatment with anakinra
Receipt of live vaccine \<3 months prior to enrollment
Previous treatment with an IL-1 antagonist for any clinical indication
First-degree relative with a diagnosis of a CAPS disease
History of active narcotic abuts, including prescription narcotics
Pregnant or lactating females
Non-English speaking patients
Seropositive for Hepatitis B, C, HIV or tuberculosis on screening, with the exception of presence of antibodies to Hepatitis B in subjects reporting prior vaccination, and presence of positive skin testing for TB in subjects who received BCG in the past
History of suicidal ideation, significant depression that resulted in hospitalization, or answers "yes" during C-SSR screening
Prior participation in any type of clinical trial using a medication that inhibits interleukin-1 activity
Known hypersensitivity to E.coli derived products

What this trial measures

  • Sustained improvement in hearing thresholdsHearing improvement from pre-treatment thresholds at day 28

    Determine whether those treated with anakinra demonstrate a sustained improvement in hearing thresholds compared with their pre-anakinra treatment threshold. Improvement will be defined by an improvement of 15dB at 1 frequency or 10dB at 2 contiguous frequencies with no greater than a 5dB worsening all remaining frequencies

  • Sustained improvement in hearing thresholdsHearing improvement from pre-treatment thresholds at day 42

    threshold. Improvement will be defined by an improvement of 15dB at 1 frequency or 10dB at 2 contiguous frequencies with no greater than a 5dB worsening all remaining frequencies