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New treatment option for Autoimmune Inner Ear Disease
Official title Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
ClinicalTrials.gov ID: NCT03587701
What this study is testing
What is Anakinra 100Mg/0.67Ml Inj Syringe (Period 1)?
Anakinra 100Mg/0.67Ml Inj Syringe (Period 1) is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for autoimmune inner ear disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
- Patients must have been treated with oral or IT prednisone with no demonstrable improvement or attempted to be treated and deemed intolerant. Steroid...
You likely can't join if
- Evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct) based on...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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 people reporting prior vaccination, and presence of positive skin testing for TB in...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Hyde Park, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Hyde Park, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.