Who is sponsoring NCT03587701?

NCT03587701 is sponsored by Northwell Health.

What drugs are being tested in NCT03587701?

Interventions in NCT03587701: Anakinra 100Mg/0.67Ml Inj Syringe (Period 1), Placebo injection (Period 1), Anakinra 100Mg/0.67Ml Inj Syringe (Period 2), Placebo injection (Period 2).

What condition does NCT03587701 study?

NCT03587701 studies Autoimmune Inner Ear Disease, Meniere's Disease.

Is NCT03587701 still recruiting?

NCT03587701 is currently recruiting now. Last updated 15 April 2026.

Last reviewed 2026-04-15 · How we verify

NCT03587701

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 2 Last updated 15 April 2026

What this trial tests

Phase 2 trial testing Anakinra 100Mg/0.67Ml Inj Syringe (Period 1) in Autoimmune Inner Ear Disease in 57 participants. Currently enrolling.

Timeline

3 January 2019

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Northwell Health
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	57
Start date	3 January 2019
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

Anakinra 100Mg/0.67Ml Inj Syringe (Period 1) — full drug profile →
Placebo injection (Period 1)
Anakinra 100Mg/0.67Ml Inj Syringe (Period 2) — full drug profile →
Placebo injection (Period 2)

Conditions studied

Autoimmune Inner Ear Disease — all drugs for Autoimmune Inner Ear Disease →
Meniere's Disease — all drugs for Meniere's Disease →

Sponsor

Northwell Health — full company profile →

Who can join

Adults 18 to 75, any sex, with Autoimmune Inner Ear Disease or Meniere's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Recent Therapeutic Progress and Future Perspectives for the Treatment of Hearing Loss.
Lye J, Delaney DS, Leith FK, Sardesai VS, et al · · 2023 · cited 16× · PMID 38137568 · DOI 10.3390/biomedicines11123347
Corticosteroid-Resistant and Corticosteroid-Dependent AIED Patients Treated With Anakinra: A Decade of Experience.
Vambutas A, Mullooly V, Weber S, Pathak S. · · 2025 · PMID 40767813 · DOI 10.1097/mao.0000000000004553

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03587701 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northwell Health
Last refreshed: 15 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03587701.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing