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

PHASE2RecruitingINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

January 3, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Autoimmune Inner Ear DiseaseMeniere'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)

Trial Locations (1)

11042

RECRUITING

Northwell Health, Hearing& Speech Center, New Hyde Park

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Swedish Orphan Biovitrum

INDUSTRY

lead

Northwell Health

OTHER