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

NCT05776459 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: AC102-201
• Study Type: interventional
• Target: 210
• Locations: 6 countries
• Sites: 39

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).

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

Outcome Measures

Primary Outcomes (1)

• Change in pure tone audiometry (PTA; dB)

  Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28

  28 days

Secondary Outcomes (1)

• Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists

  14, 28, 56, 84 days

Study Arms (2)

AC102

EXPERIMENTAL

AC102 gel and placebo tablets

Drug: AC102 gel; Other: Placebo Tablets

Prednisolone

ACTIVE COMPARATOR

Placebo gel and prednisolone tablets

Drug: Prednisolone; Other: Placebo gel

Interventions

AC102 gel DRUG

Drug: AC102 Single intratympanic injection

AC102

Prednisolone DRUG

Active comparator: Prednisolone Tablets taken daily by mouth

Prednisolone

Placebo Tablets OTHER

Placebo Tablets taken daily by mouth

AC102

Placebo gel OTHER

Placebo Single intratympanic injection

Prednisolone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AudioCure Pharma GmbH: lead

Study Sites (39)

Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde

Graz, 8036, Austria

Location

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, 4010, Austria

Location

Universitätsklinik für Hals-Nasen-Ohren-Krankheiten

Salzburg, 5020, Austria

Location

Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten

Vienna, 1090, Austria

Location

Zdravotnická zařízení Olomouc, ORL

Olomouc, 779 00, Czechia

Location

Pardubická nemocnice, Klinika ORL a chirurgie hlavy a krku

Pardubice, 532 03, Czechia

Location

Fakultní nemocnice v Motole

Prague, 150 06, Czechia

Location

Heilig Geist Hospital

Bensheim, 64625, Germany

Location

Klinik für Hals-, Nasen-, Ohrenheilkunde - Charité Campus Benjamin Franklin - HNO Hochschulambulanz

Berlin, 10117, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

University Hospital Dresden 'Carl Gustav Carus' - HNO

Dresden, 01307, Germany

Location

Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie

Greifswald, 17475, Germany

Location

Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie

Halle, 06120, Germany

Location

HNO-Praxis Eidelstedter Platz

Hamburg, 22523, Germany

Location

Klinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum

Jena, 07747, Germany

Location

Universitätsmedizin der Johannes Gutenberg Universität Mainz Hals-, Nasen-, Ohrenklinik und Poliklinik

Mainz, 51131, Germany

Location

Johannes Weseling Clinic Minden

Minden, 32429, Germany

Location

Klinikum rechts der Isar

München, 81675, Germany

Location

Evangelisches Krankenhaus - Universitätsklinik für HNO

Oldenburg, 26122, Germany

Location

Universitätsklinikum Regensburg - Klinik für HNO-Heilkunde

Regensburg, 93053, Germany

Location

SRH Zentralklinikum Suhl GmbH

Suhl, 98527, Germany

Location

Universitätsklinikum HNO

Würzburg, 97080, Germany

Location

Centrum Medyczne Kwiatowa

Bydgoszcz, 85-047, Poland

Location

Centrum Medyczne MAVIT - Szpital Specjalistyczny Katowice

Katowice, 40-431, Poland

Location

ALL-MED Cetrum Medyczne

Lodz, 94-046, Poland

Location

Oddział Laryngologii

Opole, 45-418, Poland

Location

Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie

Rzeszów, 35-055, Poland

Location

Uniwersytecki Szpital Kliniczny Nr 1

Szczecin, 71-252, Poland

Location

Trialmed

Warsaw, 02-482, Poland

Location

University Clinical Centre of Serbia

Belgrade, 11000, Serbia

Location

Clinical Hospital Centar "dr Dragisa Misovic-Dedinje"

Belgrade, 11040, Serbia

Location

Military Medical Academy - ENT department

Belgrade, 11040, Serbia

Location

Clinical Hospital Centre Zvezdara

Belgrade, 11050, Serbia

Location

Clinical-Hospital Center Zemun

Belgrade, 11080, Serbia

Location

Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council

Ivano-Frankivsk, 76000, Ukraine

Location

Communal non-profit enterprise "Central city clinical hospital of Ivano-Frankivsk city council"

Ivano-Frankivsk, 76018, Ukraine

Location

Municipal non-profit enterprise Oleksandrivska clinical hospital of Kyiv of the executive body of Kyiv city council

Kyiv, 01601, Ukraine

Location

MC Universal Clinic Oberig of Kapytal LLC

Kyiv, 03057, Ukraine

Location

LLC Clinic of Healthy Family Astramed

Uzhhorod, 88000, Ukraine

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Loss, Unilateral

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Reimar Schlingensiepen, MD

  AudioCure Pharma GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 20, 2023
• Study Start: October 13, 2022
• Primary Completion: February 28, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

UA (5); DE (15); SE (5); CZ (3); AU (4); PL (7)