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Completed

NCT Number: NCT01950312

The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy in patients with steroid resistant Autoimmune Inner Ear Disease.

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Key information

Conditions

Autoimmune Inner Ear Disease Ear Diseases Endolymphatic Hydrops Hearing Disorders Hearing Loss Hearing Loss, Sudden Labyrinth Diseases Meniere Disease Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Long Island Jewish Medical Center, Hearing & Speech Center

New Hyde Park, New York, 11040, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Autoimmune Inner Ear Disease with active deterioration in at least one ear
  • Failure to respond to a trial of high-dose corticosteroid therapy
  • Contraceptive measures adequate to prevent pregnancy during the study

Exclusion criteria

  • Evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct)
  • History of active or chronic infections
  • Currently receiving, or having received treatment for a malignancy in the past three years
  • Hearing loss that coincides with significant, disabling episodes of vertigo
  • History of allergic or anaphylactic reactions to monoclonal antibodies
  • Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

gevokizumab

Drug

Primary outcomes

  1. Improved hearing threshold, as defined by an improvement in either the PTA (Pure Tone Average) of >=5 dB (Decibel), or 12% in the WRS (Word Recognition Score)

    Time frame: Day 28 to Day 84

Sponsors and collaborators

Lead sponsor

XOMA (US) LLC

Industry

Collaborators

  • Feinstein Institute for Medical Research
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

An Open-label Study of the Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2013
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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