RecruitingPhase 2NCT03587701

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

A Phase II Placebo Controlled Study of the Effects of Anakinra (Kineret) in Subjects With Corticosteroid-Resistant/Intolerant Meniere's Disease (CR-MD) and Corticosteroid-Resistant/Intolerant Autoimmune Inner Ear Disease Disease (CR-AIED)


Sponsor

Northwell Health

Enrollment

57 participants

Start Date

Jan 3, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests anakinra, an anti-inflammatory drug that blocks interleukin-1 (IL-1), in patients with Autoimmune Inner Ear Disease (AIED) or Meniere's Disease who have not responded to — or cannot tolerate — corticosteroids. Both conditions can cause progressive, debilitating hearing loss, and when steroid treatment fails, there are very few alternatives. AIED and Meniere's Disease are believed to involve immune-mediated inflammation attacking the inner ear. By blocking IL-1, anakinra may reduce this inflammation and stabilize or even improve hearing. The study targets patients whose hearing has continued to worsen despite appropriate steroid therapy. Adults aged 18–75 with documented hearing decline and confirmed failure of steroid treatment, who are fluent in English, are eligible. You may be eligible if you: - Are between 18 and 75 years of age - Have been diagnosed with AIED or Meniere's Disease with documented audiological decline - Have not responded to or cannot tolerate corticosteroid treatment - Have completed all steroid therapy (including intratympanic) - Are fluent in English You may NOT be eligible if you: - Have previously received gentamicin treatment for Meniere's Disease - Are currently on methotrexate, anti-TNF therapy, or other immunosuppressive medications - Have been treated for any malignancy (cancer) in the past 3 years - Have significant kidney disease (creatinine clearance < 49 mL/min) - Are currently pregnant or breastfeeding - Are positive for HIV, active Hepatitis B or C, or active tuberculosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnakinra 100Mg/0.67Ml Inj Syringe (Period 1)

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)

DRUGPlacebo injection (Period 1)

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

DRUGAnakinra 100Mg/0.67Ml Inj Syringe (Period 2)

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)

DRUGPlacebo injection (Period 2)

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


Locations(1)

Northwell Health, Hearing& Speech Center

New Hyde Park, New York, United States

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NCT03587701


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