Back to results

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

Primary Purpose

Autoimmune Inner Ear Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

gevokizumab

About this trial

This is an interventional treatment trial for Autoimmune Inner Ear Disease focused on measuring Autoimmune Inner Ear Disease, Inner Ear Disease, Meniere's Disease, Sudden Sensorineural Hearing Loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Long Island Jewish Medical Center, Hearing & Speech Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gevokizumab

Arm Description

Solution for subcutaneous injection

Outcomes

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT01950312

First Posted

September 20, 2013

Last Updated

February 2, 2016

Sponsor

XOMA (US) LLC

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01950312

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

XOMA (US) LLC

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Inner Ear Disease

Keywords

Autoimmune Inner Ear Disease, Inner Ear Disease, Meniere's Disease, Sudden Sensorineural Hearing Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

gevokizumab

Arm Type

Experimental

Arm Description

Solution for subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

gevokizumab

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Long Island Jewish Medical Center, Hearing & Speech Center

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs