A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease

December 12, 2017 updated by: Andrea Vambutas

A Phase I/II Open-label Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED) that did not respond to oral steroid therapy for a sudden decline in hearing. The patients to be enrolled will have recently completed a course of oral steroids and demonstrated no change in their audiometric thresholds following corticosteroid therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with immune mediated hearing loss (also known as autoimmune hearing loss) are typically treated with corticosteroids. Of those treated, approximately 60% respond, however, that response may be lost over time. Other therapies use to date have proven largely ineffectual in improving hearing. This study proposes a phase I open label clinical trial of Anakinra for corticosteroid-resistant patients to determine if this therapy is efficacious in hearing restoration.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11040
        • North Shore-LIJ Hearing and Speech Center

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.

Eligibility Criteria

Ages Eligible for Study

9 years to 71 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bilateral sensorineural hearing loss with an active decline in hearing in one ear
  • No audiometric improvement with 28-30 days of oral prednisone or other corticosteroid, including an initial dose of 60mg per day for 14 days
  • Enrollment within 14 days of completion of corticosteroid therapy
  • Age 13 years and older
  • No evidence of neutropenia (low white blood cell count)
  • No evidence of retrocochlear pathology (ie. acoustic neuroma/vestibular schwannoma)
  • May have concurrent, systemic autoimmune disease

Exclusion Criteria:

  • Age over 75, or less than 13
  • Neutropenia
  • Renal insufficiency
  • Pregnant females
  • Unilateral hearing loss
  • Patients with any immunodeficiency syndrome
  • Patients receiving methotrexate or any TNF (tumor necrosis factor) antagonist therapy
  • Patients with chronic infections
  • Patients treated for a malignancy within the past 3 years
  • Patients with a latex allergy
  • Patients with an inner ear anomaly
  • Patients with retrocochlear pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm-Open Label
Single Arm-Open Label use of Anakinra
Drug: Anakinra
100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.
Other Names:
  • Kineret

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease
Time Frame: 180 days
The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Serious Adverse Events Reported
Time Frame: 84 days
To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrea Vambutas

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Andrea Vambutas, MD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

December 28, 2010

First Submitted That Met QC Criteria

December 28, 2010

First Posted (Estimate)

December 29, 2010

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21DC011827-01 (U.S. NIH Grant/Contract)
  • R33DC011827 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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