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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01950312
First Posted: September 25, 2013
Last Update Posted: February 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Feinstein Institute for Medical Research
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
XOMA (US) LLC
  Purpose
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.

Condition Intervention Phase
Autoimmune Inner Ear Disease Drug: gevokizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of the Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

Resource links provided by NLM:


Further study details as provided by XOMA (US) LLC:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: August 2013
Study Completion Date: December 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gevokizumab
Solution for subcutaneous injection
Drug: gevokizumab

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950312


Locations
United States, New York
Long Island Jewish Medical Center, Hearing & Speech Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
XOMA (US) LLC
Feinstein Institute for Medical Research
National Institute on Deafness and Other Communication Disorders (NIDCD)
  More Information

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT01950312     History of Changes
Other Study ID Numbers: X052180
R33DC011827 ( U.S. NIH Grant/Contract )
First Submitted: September 20, 2013
First Posted: September 25, 2013
Last Update Posted: February 3, 2016
Last Verified: February 2016

Keywords provided by XOMA (US) LLC:
Autoimmune Inner Ear Disease
Inner Ear Disease
Meniere's Disease
Sudden Sensorineural Hearing Loss

Additional relevant MeSH terms:
Ear Diseases
Labyrinth Diseases
Labyrinthitis
Otorhinolaryngologic Diseases
Otitis