A Phase 1/2 interventional study of Anakinra in Sensorineural Hearing Loss and Autoimmune Inner Ear Disease, sponsored by Andrea Vambutas. Completed at 1 site in United States. Open to participants aged 13 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by Andrea Vambutas · Phase 1/2, Interventional, and Treatment
Among 141 studies in Hearing Loss, Sensorineural with a site in United States — 34 open to participants now, 38 under way, 1 of them phase 3. Hearing Loss, Sensorineural · United States.
Among the 141 studies in Hearing Loss, Sensorineural with a site in United States, this one is the 89th largest by enrollment of the 115 interventional ones that give a count, is one of 2 that started in 2011, is one of 8 in phase 1/2, and was the 15th registered.
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 101 are open to participants now.
Browse Hearing Loss, Sensorineural studies →34 of the 141 studies in Hearing Loss, Sensorineural with a site in United States are open now. Recruiting first, the newest first:
Skylark Bio Inc. · Sites in United States
Ages 9 mo–7 yrs
University of South Florida · Sites in United States
Ages 18–80 · Healthy volunteers
Purdue University · Sites in United States
Ages 18+
Hearts for Hearing · Sites in United States
Ages 5+ · Healthy volunteers
Cochlear · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 70 Hearing Loss, Sensorineural studies recruiting now, 39 (56%) set no upper age limit and 19 (27%) stop at 75 or younger; 26 take children under 18; 17 take healthy volunteers.
This study: 13 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
141 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 12 · Phase 3 3 · Phase 4 1
First in 1998; this study’s year is marked. 2 started in 2011.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 13 is below the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.
Median enrollment 38 across the 115 interventional studies, 100 across the 25 observational. Of the 94 that completed or were terminated, 56 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
69 of 141 have an industry lead sponsor. The 10 most frequent:
Andrea Vambutas is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Andrea Vambutas has 1 study filed under Hearing Loss, Sensorineural — fewer than ten, so there is no comparison to draw.
11 of the studies in Hearing Loss, Sensorineural with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06960616Massachusetts Eye and Ear InfirmaryImproving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy | 2026-11-26 |
| NCT04506853Med-El CorporationSingle-Sided Deafness and Asymmetric Hearing Loss | 2026-12-21 |
| NCT04707885Ohio State UniversityClinical Utility of Residual Hearing in the Cochlear Implant Ear | 2026-12-31 |
| NCT07081542AdventHealthComparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants | 2027-01-31 |
| NCT05554692University of Maryland, College ParkPeripheral and Central Influences on Auditory Temporal Processing & Speech Perception in Older Cochlear Implantees | 2027-03 |
Add all 11 to your calendar (.ics) → With an account.
Among the 141 studies in Hearing Loss, Sensorineural with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED) that did not respond to oral steroid therapy for a sudden decline in hearing. The patients to be enrolled will have recently completed a course of oral steroids and demonstrated no change in their audiometric thresholds following corticosteroid therapy.
Patients with immune mediated hearing loss (also known as autoimmune hearing loss) are typically treated with corticosteroids. Of those treated, approximately 60% respond, however, that response may be lost over time. Other therapies use to date have proven largely ineffectual in improving hearing. This study proposes a phase I open label clinical trial of Anakinra for corticosteroid-resistant patients to determine if this therapy is efficacious in hearing restoration.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single Arm-Open Label use of Anakinra
Drug: Anakinra
100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.
Also known as: Kineret
To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease
The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.
Time frame: 180 days
Number of Serious Adverse Events Reported
To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra
Time frame: 84 days
| Milestone | Open Label Trial |
|---|---|
| Started | 12 |
| Completed | 10 |
| Not completed | 2 |
| Withdrew: Adverse event | 2 |
The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.
| responders | Single Arm |
|---|---|
| To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease | 7 |
To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra
| reported SAEs | Single Arm |
|---|---|
| Number of Serious Adverse Events Reported | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm | — | 0/12 (0%) | 10/12 (83.3%) |
| Event | Single Arm |
|---|---|
| Injection site reactionsSkin and subcutaneous tissue disorders | 10/12 |
| HeadacheNervous system disorders | 4/12 |
| VertigoNervous system disorders | 3/12 |
| TinnitusEar and labyrinth disorders | 2/12 |
| NauseaGastrointestinal disorders | 2/12 |
| Influenza like illnessRespiratory, thoracic and mediastinal disorders | 1/12 |
| CellulitisSkin and subcutaneous tissue disorders | 1/12 |
| SinusitisRespiratory, thoracic and mediastinal disorders | 1/12 |
| WheezingRespiratory, thoracic and mediastinal disorders | 1/12 |
| Psoriasis FlareSkin and subcutaneous tissue disorders | 1/12 |
Corticosteroid-resistant AIED patients.
| Age, Categorical(Participants) | Single Arm |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Single Arm |
|---|---|
| Female | 6 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | Single Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Single Arm |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Single Arm |
|---|---|
| United States | 13 |
The record gives a start of Jun 2011, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2015, 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Interleukin 1 Receptor Antagonist Protein
Andrea Vambutas