Recruiting

Phase 2

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

Sponsor:

Northwell Health

Code:

NCT03587701

Conditions

Autoimmune Inner Ear Disease

Meniere's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Anakinra 100Mg/0.67Ml Inj Syringe (Period 1)

Placebo injection (Period 1)

Anakinra 100Mg/0.67Ml Inj Syringe (Period 2)

Placebo injection (Period 2)

Study Details

Brief 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.

Conditions

Autoimmune Inner Ear Disease

Meniere's Disease

Study ID

NCT03587701

Start date

Jan 3, 2019

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

57 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A

This group will be randomized to receive intervention of 42 consecutive days of anakinra (100mg/0.67ml) in period 1 followed by an additional 42 consecutive days of anakinra (100mg/0.67ml) in period 2

experimental: Group B

This group will be randomized to receive intervention of 42 consecutive days of anakinra (100 mg/0.67ml) in period 1 followed by 42 consecutive days of placebo in period 2

experimental: Group C

This group will be randomized to receive intervention of placebo for 42 consecutive days in period 1 followed by 42 consecutive days of anakinra (100mg/0.67ml) in period 2

Interventions

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)

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)

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)

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 measure

Sustained improvement in hearing thresholds [ Time Frame: Hearing improvement from pre-treatment thresholds at day 28 ]
Sustained improvement in hearing thresholds [ Time Frame: Hearing improvement from pre-treatment thresholds at day 42 ]

Central Contacts and Locations

Central contacts

Ginny Mullooly, RN

718-470-7974 gmullool@northwell.edu

Andrea Vambutas, MD

718-470-7550 avambuta@northwell.edu

Locations

Northwell Health, Hearing& Speech Center

Recruiting

New Hyde Park, New York, United States, 11042

Contacts

Andrea Vambutas, MD

718-470-7550 avambuta@northwell.edu

Ginny Mullooly, RN

718-470-7974 gmullool@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-04-15.