Intratympanic Injection for Autoimmune Inner Ear Disease

Autoimmune Inner Ear Disease Clinical Trial

— AIED  

Official title:

Safety and Efficacy of Intratympanically Delivered Golimumab for Stabilization of Hearing in Patients With Autoimmune Inner Ear Disease: An Open-label Proof-of-concept Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01526174
• Other study ID #: HRI-002
• Secondary ID: TNFalpha
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 1, 2012
• Last updated: October 10, 2013
• Start date: March 2012
• Est. completion date: April 2014

Study information

• Verified date: October 2013
• Source: House Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The investigators plan to conduct an open-label intratympanic injection proof-of-concept trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm approach. First, the investigators propose to dose 3 individual subjects with a single intratympanic injection of golimumab and follow each for 30 days, closely examining them for adverse events. If there are no serious adverse events, with FDA approval, the investigators propose to dose 14 subjects, each with 4 intratympanic injections of golimumab.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of autoimmune inner ear disease (AIED) by the principal investigator

• Idiopathic, bilateral sensorineural hearing loss

• History of, or audiograms showing, rapid progression of hearing loss

• Bilateral loss of at least 30 dB in one or more frequencies (0.25 - 6 kHz)

• Hearing responsive on high-dose oral steroids and steroid-dependent, as determined by history and the principal investigator. The subject can be taking oral steroid, at the maintenance level, if enrolled in the First Arm and, if enrolled in the Second Arm, will begin taper after the first injection.

• Provided written informed consent for participation in the clinical study

Exclusion Criteria:

• Positive MRI for vestibular schwannoma

• Positive FTA (syphilis)

• Significant middle ear disease (e.g., otitis media)

• Positive blood test for Lyme disease

• Positive tuberculosis test

• Concurrent or past treatment or use of medications and/or substances known to cause ototoxicity(for example, aminoglycosides [e.g., gentamicin], cisplatin, loop diuretics, Yorgason et al., 2006)

• Known adverse reaction to golimumab, adalimumab, etanercept, infliximab, rituximab, ustekinumab, or other biologic immunomodulators

• Concurrent (within the past 3 months prior to enrollment) live viral intranasal vaccine (flu)

• Positive test for HIV

• Positive test for Hepatitis B and C

• Presence of a demyelinating disease, such as multiple sclerosis

• Women of childbearing potential only: Positive serum pregnancy test prior to the only/first injection

• Active infections

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Inner Ear Disease
• Ear Diseases
• Labyrinth Diseases
• Labyrinthitis

Intervention

Drug:
• Golimumab
Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
House Research Institute	Janssen Services, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events	Serious Adverse Events	30 days	Yes
Primary	Pure-tone threshold change	Change in pure-tone threshold from baseline to 6 week after initiation of treatment	6 weeks	No