NCT01950312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

September 20, 2013

Last Update Submit

February 2, 2016

Conditions

Autoimmune Inner Ear Disease

Keywords

Autoimmune Inner Ear DiseaseInner Ear DiseaseMeniere's DiseaseSudden Sensorineural Hearing Loss

Outcome Measures

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)

    Day 28 to Day 84

Study Arms (1)

gevokizumab

EXPERIMENTAL

Solution for subcutaneous injection

Drug: gevokizumab

Interventions

gevokizumabDRUG
gevokizumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Island Jewish Medical Center, Hearing & Speech Center

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Labyrinth DiseasesMeniere DiseaseHearing Loss, Sudden

Interventions

gevokizumab

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesEndolymphatic HydropsHearing LossHearing DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2013

First Posted

September 25, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

US(1)