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

Meniere's Disease Autoimmune Inner Ear Disease

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 clinical trial is studying a drug called Anakinra 100Mg/0.67Ml Inj Syringe (Period 1), a drug called Anakinra 100Mg/0.67Ml Inj Syringe (Period 2), and others for people with autoimmune inner ear disease and meniere's disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

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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