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Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease

ConditionsAutoimmune Inner Ear DiseaseMeniere's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNorthwell Health

About this trial

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. After day 42, a second placebo-controlled period will begin for an additional 42 days. This will be followed by a 264 day observation period, during which, hearing declines may be re-treated with anakinra after 30 days following the initial drug.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 corticosteroids even if the more active ear declines. Active deterioration is defined as a 15dB decline at one frequency (excluding 250 or 8kHz as a sole indicator) on their audiogram, or 10dB at 2+ frequencies developing in > or equal 3 days but < or equal 90 days, or if the hearing loss evolved in less than 3 days, the patient displayed features suggestive of an autoimmune disorder

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 frequency (250, 500, 1000, 2000 and 4000Hz) and <12% improvement in WRS)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anakinra 100Mg/0.67Ml Inj Syringe (Period 1)

    Drug

    pre-filled syringes of anakinra 100mg/0.67mg will be provided and will be self-administered by patients daily during first 42 days of treatment (Period 1)

  • Placebo injection (Period 1)

    Drug

    pre-filled matching placebo injections will be provided and will be self-administered by patients daily during first 42 days of treatment (Period 1)

  • Anakinra 100Mg/0.67Ml Inj Syringe (Period 2)

    Drug

    pre-filled syringes of anakinra 100mg/0.67mg will be provided and will be self-administered by patients daily during next 42 days of treatment (Period 2)

  • Placebo injection (Period 2)

    Drug

    pre-filled matching placebo injections will be provided and will be self-administered by patients daily during next 42 days of treatment (Period 2)

Treatment groups

57 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 2 interventions
Group B: Group BExperimental treatment 2 interventions
Group C: Group CExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Sustained improvement in hearing thresholds

Determine whether those treated with anakinra demonstrate a sustained improvement in hearing thresholds compared with their pre-anakinra treatment threshold. Improvement will be defined by an improvement of 15dB at 1 frequency or 10dB at 2 contiguous frequencies with no greater than a 5dB worsening all remaining frequencies

Time frame
Hearing improvement from pre-treatment thresholds at day 28
2

Sustained improvement in hearing thresholds

threshold. Improvement will be defined by an improvement of 15dB at 1 frequency or 10dB at 2 contiguous frequencies with no greater than a 5dB worsening all remaining frequencies

Time frame
Hearing improvement from pre-treatment thresholds at day 42

Secondary outcomes

1

Improved Word Recognition

Determine whether those treated with anakinra demonstrate a sustained improvement in word recognition score compared with their pre-anakinra treatment threshold. Improvement will be defined by an improvement of greater than 12% change in value

Time frame
at day 28
2

Improved Word Recognition

Determine whether those treated with anakinra demonstrate a sustained improvement in word recognition score compared with their pre-anakinra treatment threshold. Improvement will be defined by an improvement of greater than 12% change in value

Time frame
at day 42

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Swedish Orphan Biovitrum

Collaborator

Source ClinicalTrials.gov
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