Effects of Anakinra in Subjects With Autoimmune Inner Ear Disease

  • STATUS
    Recruiting
  • days left to enroll
    16
  • participants needed
    57
  • sponsor
    Northwell Health
Updated on 14 February 2022

Summary

A Phase II randomized, placebo controlled study design of anakinra (Kineret) in corticosteroid-resistant Meniere's disease (CR-MD)and corticosteroid-resistant 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.

Description

This study will be evaluating whether or not anakinra (kineret) is superior to placebo for improving sustained hearing thresholds in patients with CR-MD and CR-AIED. Final enrollment is contingent on an acute decline in hearing in the active ear and 2 sequential audiograms greater than or equal to 28 days apart that shows a stable or declining hearing threshold and word recognition score not improved with corticosteroid therapy. Anakinra (kineret) 100mg/0.67ml prefilled syringes or placebo injection will be randomized at 2:1 allocation and will be self-administered by the patient daily for 42 days. After day 42, a second placebo-controlled period will begin for an additional 42 days (all patients will receive anakinra for either 42 or 84 days depending on the randomization assignment). A 264 day observation period will begin after day 84, during which the option to retreat with anakinra will be offered to those patients that responded to the therapy in the first 84 day period.

Details
Condition Autoimmune Inner Ear Disease
Treatment Anakinra 100Mg/0.67Ml Inj Syringe (Period 1), Placebo injection (Period 1), Anakinra 100Mg/0.67Ml Inj Syringe (Period 2), Placebo injection (Period 2)
Clinical Study IdentifierNCT03587701
SponsorNorthwell Health
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

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 within 45 days prior to trial enrollment with no demonstrable improvement by either PT or WRS. For patients treated with oral prednisone they must have completed a minimum of 60mg of prednisone (or equivalent) for 7 days with a variable taper and have completed the therapy by greater or equal to 14 days prior to enrollment
> or equal to 14 days since any prior steroid usage
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
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