Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)

Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05776459

Enrollment

210

Registered

2023-03-20

Start date

2022-10-13

Completion date

2026-07-31

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Sensorineural

Keywords

Hearing Loss, Hearing impairment, Hearing Loss, Sensorineural, Ear Diseases, Otorhinolaryngologic Diseases, Hearing Loss, Unilateral, Intratympanic Administration, Restoration of Hearing Loss

Brief summary

The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).

Interventions

DRUGAC102 gel

Drug: AC102 Single intratympanic injection

DRUGPrednisolone

Active comparator: Prednisolone Tablets taken daily by mouth

OTHERPlacebo Tablets

Placebo Tablets taken daily by mouth

OTHERPlacebo gel

Placebo Single intratympanic injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Male or female patients aged between 18 and 85 years * Unilateral ISSNHL * Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization * An absolute air conduction hearing threshold of at least 65 dB, * Patients with a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear

Exclusion criteria

* Insufficient handling of the language used in the speech audiometry tests * Bilateral hearing loss * Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time * Congenital hearing loss * Conductive hearing loss or combined hearing loss determined by a 4PTA \> 10 dB * History of ISSNHL in the past 1 years in the affected ear

Design outcomes

Primary

Measure	Time frame	Description
Change in pure tone audiometry (PTA; dB)	28 days	Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28

Secondary

Measure	Time frame	Description
Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists	14, 28, 56, 84 days	Scores between 0% to 100% correctly understood words at predefined sound pressure levels are determined

Countries

Austria, Czechia, Germany, Poland, Serbia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026