The Effects of Gevokizumab in Corticosteroid-resistant Su... | NCT01950312

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

NCT01950312

Sponsor

XOMA (US) LLC

Status

Completed

Last Update Posted

Feb 3, 2016Estimated

Enrollment

10Estimated

Phase

Phase 2

Conditions

Autoimmune Inner Ear Disease

Interventions

gevokizumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R33DC011827	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Oct 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 20, 2013

First Submission Date that Met QC Criteria

Sep 20, 2013

First Posted Date

Sep 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2016

Last Update Posted Date

Feb 3, 2016Estimated

Name	Class
Feinstein Institute for Medical Research	OTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
gevokizumab	Experimental	Solution for subcutaneous injection	Drug: gevokizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gevokizumab	Drug		gevokizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Long Island Jewish Medical Center, Hearing & Speech Center		New Hyde Park	New York	11040	United States

Condition Browse Module

MeSH Terms

ID	Term
D007759	Labyrinth Diseases
D008575	Meniere Disease
D003639	Hearing Loss, Sudden

Ancestor Terms

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D018159	Endolymphatic Hydrops
D034381	Hearing Loss

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C547697	gevokizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided