RECRUITING

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

Conditions

Autoimmune Inner Ear Disease Meniere's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Phase II Placebo Controlled Study of the Effects of Anakinra (Kineret) in Subjects With Corticosteroid-Resistant/Intolerant Meniere's Disease (CR-MD) and Corticosteroid-Resistant/Intolerant Autoimmune Inner Ear Disease Disease (CR-AIED)

Quick Facts

Study Start:2019-01-03

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03587701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Ginny Mullooly, RN

CONTACT

718-470-7974

gmullool@northwell.edu

Andrea Vambutas, MD

CONTACT

718-470-7550

avambuta@northwell.edu

Principal Investigator

Andrea Vambutas, MD

PRINCIPAL_INVESTIGATOR

Northwell Health

Study Locations (Sites)

Northwell Health, Hearing& Speech Center

New Hyde Park, New York, 11042

United States

Collaborators and Investigators

Sponsor: Northwell Health

Andrea Vambutas, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-03

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-01-03

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Autoimmune Inner Ear Disease
Meniere's Disease