Autoimmune Inner Ear DiseasePhase 2NCT01950312
The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
A Phase 2 study testing gevokizumab in people with Autoimmune Inner Ear Disease, run by XOMA (US) LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Inner Ear Disease
- What is being tested?
- gevokizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Island Jewish Medical Center, Hearing & Speech Center
New Hyde Park, New York, 11040
About this study
Official title: An Open-label Study of the Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
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.
- Conditions
- Autoimmune Inner Ear Disease
- Being tested
- gevokizumab
- Keywords
- Autoimmune Inner Ear Disease, Inner Ear Disease, Meniere's Disease, Sudden Sensorineural Hearing Loss
- Medical subject headings
- Labyrinth Diseases, Meniere Disease, Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gevokizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| gevokizumab | Experimental | Solution for subcutaneous injection Receives: Drug: gevokizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 28 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Inner Ear DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Feinstein Institute for Medical Research, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950312
- Sponsor's protocol ID
- X052180
- Other IDs
- R33DC011827
- Status last verified
- Feb 2016
- First submitted
- 20 Sep 2013
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of the Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
- ClinicalTrials.gov ID
- NCT01950312
- Acronym / sponsor ID
- X052180
- Conditions
- Autoimmune Inner Ear Disease
- Keywords
- Autoimmune Inner Ear Disease, Inner Ear Disease, Meniere's Disease, Sudden Sensorineural Hearing Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Collaborators
- Feinstein Institute for Medical Research, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Aug 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gevokizumab | Experimental | Drug: gevokizumabSolution for subcutaneous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gevokizumab | Drug | gevokizumab |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gevokizumab in people with Autoimmune Inner Ear Disease, run by XOMA (US) LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.