NCT03587701 · Northwell Health
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
What this study is about
A Phase II randomly assigned, 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 randomly assigned by a 2:1 allocation to anakinra or placebo for 42 continuous days.
View original scientific description
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.
Interventions
DRUG
Anakinra 100Mg/0.67Ml Inj Syringe (Period 1)
pre-filled syringes of anakinra 100mg/0.67mg will be provided and will be self-administered by patients daily during first 42 days of treatment (Period 1)
DRUG
Placebo injection (Period 1)
pre-filled matching placebo injections will be provided and will be self-administered by patients daily during first 42 days of treatment (Period 1)
DRUG
Anakinra 100Mg/0.67Ml Inj Syringe (Period 2)
pre-filled syringes of anakinra 100mg/0.67mg will be provided and will be self-administered by patients daily during next 42 days of treatment (Period 2)
DRUG
Placebo injection (Period 2)
pre-filled matching placebo injections will be provided and will be self-administered by patients daily during next 42 days of treatment (Period 2)
Primary outcome measures
Sustained improvement in hearing thresholds
Time frame: Hearing 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 thresholds
Time frame: Hearing 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- New Hyde Park, New York
Collaborators
Swedish Orphan Biovitrum
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations