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

Autoimmune Inner Ear Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950312
• Other study ID #: X052180
• Secondary ID: R33DC011827
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2013
• Last updated: February 2, 2016
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Inner Ear Disease
• Ear Diseases
• Labyrinth Diseases
• Labyrinthitis

Intervention

Drug:
• gevokizumab

Locations

Country	Name	City	State
United States	Long Island Jewish Medical Center, Hearing & Speech Center	New Hyde Park	New York

Sponsors (3)

Lead Sponsor	Collaborator
XOMA (US) LLC	Feinstein Institute for Medical Research, National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Day 28 to Day 84	No