Autoimmune Inner Ear DiseasePhase 1/2AIEDNCT01526174
Intratympanic Injection for Autoimmune Inner Ear Disease
A Phase 1/2 study testing Golimumab in people with Autoimmune Inner Ear Disease, run by House Research Institute.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Autoimmune Inner Ear Disease
- What is being tested?
- Golimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Apr 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
About this study
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
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.
- Conditions
- Autoimmune Inner Ear Disease
- Being tested
- Golimumab
- Keywords
- autoimmune, hearing loss, bilateral hearing loss, steroid-dependent
- Medical subject headings
- Hearing Loss, Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolimumabDrug
Also called Simponi
Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections
| Study group | Role | What they receive |
|---|---|---|
| First Arm | Experimental | Determine safety of intratympanic injection Receives: Drug: Golimumab |
| Second Arm | Experimental | Efficacy evaluation of 4 intratympanic injections Receives: Drug: Golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Serious Adverse Events
Measured: 30 days
Pure-tone threshold change
Change in pure-tone threshold from baseline to 6 week after initiation of treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013 (estimated)
- Study completionApr 2014 (estimated)
Why it stopped: House Research no longer conducting research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Inner Ear DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- House Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Services, LLC
- Responsible party
- Sponsor
- Investigators
- Jennifer Derebery, MD, Principal investigator, House Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526174
- Sponsor's protocol ID
- HRI-002
- Other IDs
- TNFalpha
- Acronym
- AIED
- Status last verified
- Oct 2013
- First submitted
- 1 Feb 2012
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01526174
- Acronym / sponsor ID
- AIED / HRI-002
- Conditions
- Autoimmune Inner Ear Disease
- Keywords
- autoimmune, hearing loss, bilateral hearing loss, steroid-dependent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: House Research no longer conducting research.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- House Research InstituteUniversity, hospital or other
- Collaborators
- Janssen Services, LLC
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Arm | Experimental | Drug: GolimumabDetermine safety of intratympanic injection |
| Second Arm | Experimental | Drug: GolimumabEfficacy evaluation of 4 intratympanic injections |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GolimumabAlso: SimponiIntratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections | Drug | First Arm, Second Arm |
Primary outcome
Serious Adverse Events
Time frame: 30 days
Serious Adverse Events
Pure-tone threshold change
Time frame: 6 weeks
Change in pure-tone threshold from baseline to 6 week after initiation of treatment
Results and safety
The study was stopped early (reason given: House Research no longer conducting research.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Derebery, MD principal investigator
House Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Golimumab in people with Autoimmune Inner Ear Disease, run by House Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: House Research no longer conducting research.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.