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

NCT03587701 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Autoimmune Inner Ear Disease
  • Meniere's Disease

Interventions

DRUG

Anakinra 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)

DRUG

Placebo 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)

DRUG

Anakinra 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)

DRUG

Placebo 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)

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    collaborator INDUSTRY

  • Northwell Health

    lead OTHER

Principal Investigators

  • Andrea Vambutas, MD · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-03
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03587701 on ClinicalTrials.gov