NCT01950312

CompletedPhase 2

The Effects of Gevokizumab in Corticosteroid-resistant Subje...

XOMA (US) LLC Source

XOMA (US) LLC

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

X052180

Secondary identifiers

R33DC011827

NIH

Study Type

interventional

Estimated enrollment

10

Locations

1 country

Sites

1

Timeline

Study Start

August 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2015

Actual (reported)

Study Completion

December 2015

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 10 participants
Study completion date: December 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 20, 2013
Actual (reported)
First Posted
September 25, 2013
Actual (reported)
Primary Completion
October 2015
Actual (reported)
Study Completion
December 2015
Actual (reported)

Last Updated: February 3, 2016
Status Verified: February 2016
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

XOMA (US) LLC
Industrylead
Feinstein Institute for Medical Research
Othercollaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)

Study Sites (1)

Long Island Jewish Medical Center, Hearing & Speech Center

New Hyde Park, New York, 11040, United States

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 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2015

Actual (reported)

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Not ApplicableCompleted

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Phase 3Terminated

NCT02315417

An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum

Phase 3Terminated

NCT02318914

A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum

Phase 3Terminated

NCT02326740

An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum

Phase 3Terminated

NCT03587701

Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease

Phase 2Recruiting

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.

NIHcollaborator

Study Completion

December 2015

Actual (reported)

Last Updated

February 3, 2016

Record last verified: 2016-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01950312
Data provider: ClinicalTrials.gov
Source updated: 2016-02-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:17:59 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

gevokizumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations