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

Sensorineural Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267994
• Other study ID #: 1R21DC011827-01
• Secondary ID: R33DC011827
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 28, 2010
• Last updated: December 12, 2017
• Start date: June 2011
• Est. completion date: September 2014

Study information

• Verified date: December 2017
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Inner Ear Disease
• Deafness
• Ear Diseases
• Hearing Loss
• Hearing Loss, Sensorineural
• Labyrinth Diseases
• Labyrinthitis
• Sensorineural Hearing Loss

Intervention

Drug:
• Anakinra
100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.

Locations

Country	Name	City	State
United States	North Shore-LIJ Hearing and Speech Center	New Hyde Park	New York

Sponsors (2)

Lead Sponsor	Collaborator
Andrea Vambutas	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vambutas A, Lesser M, Mullooly V, Pathak S, Zahtz G, Rosen L, Goldofsky E. Early efficacy trial of anakinra in corticosteroid-resistant autoimmune inner ear disease. J Clin Invest. 2014 Sep;124(9):4115-22. doi: 10.1172/JCI76503. Epub 2014 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease	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	Number of Serious Adverse Events Reported	To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra	84 days

External Links

•   Clinical trials at the Feinstein Institute for Medical Research