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    Summary
    EudraCT Number:2021-004323-33
    Sponsor's Protocol Code Number:AC102-201
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-01-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2021-004323-33
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy, Safety and Tolerability of a Single Injection of AC102 into the Middle Ear Compared to Oral Steroid Treatment in Patients with Sudden Hearing Loss.
    A.4.1Sponsor's protocol code numberAC102-201
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAudioCure Pharma GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAudiocure Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAudiocure Pharma GmbH
    B.5.2Functional name of contact pointClinical Research
    B.5.3 Address:
    B.5.3.1Street AddressSchlegelstraße 9
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post codeD-10115
    B.5.3.4CountryGermany
    B.5.4Telephone number+493022 18 397 19
    B.5.5Fax number+493022 18 397 99
    B.5.6E-mailclinical.ra@audiocure.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2106
    D.3 Description of the IMP
    D.3.1Product name -
    D.3.2Product code AC102
    D.3.4Pharmaceutical form Gel for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratympanic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN not yet assigned
    D.3.9.1CAS number 1688675-80-0
    D.3.9.2Current sponsor codeAC102
    D.3.9.3Other descriptive name6-fluoro-9-methyl-9H-pyrido[3,4-b]-indole
    D.3.9.4EV Substance CodeSUB193728
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Prednisolone 10 mg GALEN Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGALENpharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePrednisolone 10 mg GALEN Tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolone
    D.3.9.1CAS number 50-24-8
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel for injection
    D.8.4Route of administration of the placeboIntratympanic use (Noncurrent)
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)
    ISSNHL is most commonly defined as sensorineural hearing loss of 30dB or greater over at least three contiguous audiometric frequencies occurring within a 72-hr period.
    Inclusion within this trial applies for moderately severe to profound cases ( 65 to <100 dB) within 24 to 120 hours after onset.
    E.1.1.1Medical condition in easily understood language
    Condition when a person suddenly can not hear anymore on one ear without a clear reason.
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy of a single dose administration of AC102 compared to oral steroids in patients with moderately-severe to profound ISSNHL. The evaluation will be based on the improvement of the hearing threshold (average of the three most affected consecutive frequencies) tested by pure tone audiometry from baseline to Day 28.
    E.2.2Secondary objectives of the trial
    • Improvement of the hearing threshold over the time course of the whole study duration (up to Day 84) tested by pure tone audiometry
    • Improvement of speech recognition in quiet over the time course of the study focusing on the final test at Day 84
    • Incidence of complete, partial and no recovery
    • Percentage of patients eligible for salvage therapy
    • Improvement of Hearing Handicap Inventory Score/ Quality of Life
    • Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved informed consent form (ICF)
    2. Female or male patients aged between 18 and 80 years (inclusive) at the day of Screening
    3. Unilateral ISSNHL
    4. Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
    5. Patients with an absolute air conduction hearing threshold of at least 65 dB, but less than 100 dB (average of the three most affected consecutive frequencies between 0.25 and 8 kHz).
    6. Patients with a relative hearing loss of at least 40 dB compared to the current audiogram of the non-affected ear.
    7. Willing and able to use adequate hearing protection and to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured for the duration of their participation in this study
    8. Willing and able to protect the ear canal and middle ear from water exposure for as long as the tympanic membrane is not fully closed
    9. Willing and able to attend the trial visits
    10. Able to read and understand trial documents and follow Investigator and trial personnel instructions during visits. Willing and able to comply with procedures of audiological assessments (in particular pure tone audiometry and speech audiometry).
    11. Female patients must meet one of the following criteria:
    • If of childbearing potential – have a negative urine pregnancy test and agree to use a highly effective medically accepted contraceptive method for at least 30 days after the last study medication intake.
    • If of non-childbearing potential – should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or in a postmenopausal state (at least one year without menses at Screening)
    Male patients with sexual partners who could become pregnant must meet the following criteria:
    • Patient is unable to procreate, defined as surgically sterile (i.e. has undergone a vasectomy at last 6 months before Screening)
    • Patient agrees to use one of the accepted contraceptive regimens for at least 30 days after the last study medication intake.
    E.4Principal exclusion criteria
    1. Insufficient handling of the language used in the speech audiometry tests
    2.
    a) Bilateral acute hearing loss
    b) Sudden hearing loss in the only hearing ear (i.e. pre-existing hearing loss in the contralateral ear of 40 dB or more measured by PTA in the range of 0.5-4 kHz)
    3. Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time
    4. Congenital hearing loss
    5. Conductive hearing loss or combined hearing loss determined by a 4PTA > 10 dB
    6. Suspected perilymph fistula or round window membrane rupture in either ear
    7. Otitis media or otitis externa that is ongoing or ended within 30 days prior to randomization or is occurring several times per year
    8. Patients with abnormality of the tympanic membrane or the outer ear canal that would preclude intratympanic administration
    9. Evidence or history of vestibular schwannoma (acoustic neuroma) or other retrocochlear damage in the affected ear
    10. History of ISSNHL in the past 2 years
    11. History of radiation-induced hearing loss, fluctuating hearing, endolymphatic hydrops or Menière’s disease in either ear
    12. History of chronic inflammatory or chronic suppurative ear disease or cholesteatoma in the affected ear
    13. History of otosclerosis in the affected ear
    14. Family history of hearing impairment other than age related
    15. History within the past 2 years or presence of drug abuse or alcoholism based on patient reports and judgment of the investigator
    16. Positive urine screen of drugs of abuse at Screening
    17. Acute SARS-CoV-2 infection (antigen-test)
    18. If any of the following diseases is known:
    • Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
    • Systemic mycosis and parasitosis (amoebic or worm infections)
    • Acute and chronic bacterial infections
    • Tuberculosis
    • Severe osteoporosis
    • Narrow and wide-angle glaucoma, corneal ulceration and corneal injury
    • Severe ulcerative colitis with impending perforation, with abscesses or purulent inflammations
    • Exercise-induced angina, known class III or IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system
    • Gastric or duodenal ulcer, existing or treated within <1 year prior to randomization
    • Myasthenia gravis
    • Patients with diagnosed anxiety disorders, psychosis, depression, schizophrenia, suicidal ideation or other significant psychiatric conditions. Inclusion only after critical evaluation by the investigator
    19. Uncontrolled systolic (>180 mmHg) or diastolic (>100 mmHg) blood pressure at Screening
    20. Difficult to control diabetes.
    21. Treatment with medication listed in 4.4. of the protocol.
    22. Patients who have answered “yes” to questions 4 or 5 of the C-SSRS.
    23. Hypersensitivity to prednisolone
    24. Vaccination with live vaccines or mRNA or vector vaccines planned in the next 8 weeks or that was less than 2 weeks ago
    25. Concurrent participation in another clinical study or participation in another clinical study within 30 days or 5 half-lives of the respective experimental drug (whichever is longer) prior to Screening Visit
    26. Women who are breast feeding, pregnant or plan to become pregnant during the study or women of childbearing potential who are unwilling or unable to practice an effective method of contraception
    27. Patients who are involved in the organization of the clinical investigation or are in any way dependent on the Investigator or Sponsor
    28. Major surgery within eight weeks before Screening or scheduled/planned surgery within the time frame of the study
    29. Medical reasons which, in the opinion of the investigator, preclude inclusion in the study
    30. Legal incapacity or limited legal capacity
    31. Patients who have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in absolute hearing thresholds (average of the three most affected consecutive frequencies from 0.25 to 8 kHz) measured by PTA from baseline to Day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    from baseline to Day 28
    E.5.2Secondary end point(s)
    • Absolute improvement of speech recognition from baseline to Day 84
    • Mean change in absolute hearing thresholds of PTA from baseline to Day 14, 56 and 84 at the three mostly affected consecutive frequencies and mean change of 4PTA (PTA at the frequencies 0.5, 1, 2, and 4 kHz)
    • Percentage of patients with complete, partial or no remission on Day 28, 56 and 84 based on Wilson's criteria (no recovery: ≤ 10 dB, complete: within 10 dB to the contralateral ear)
    • Absolute improvement of speech recognition in quiet from baseline to Day 14, 28 and 56
    • Percentage of patients eligible for salvage therapy
    • Improvement of scoring in HHIA from baseline to Day 28 and 84
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Absolute improvement of speech recognition from baseline to Day 84
    • Mean change in absolute hearing thresholds of PTA from baseline to Day 14, 56 and 84 at the three mostly affected consecutive frequencies and mean change of 4PTA (PTA at the frequencies 0.5, 1, 2, and 4 kHz)
    • Percentage of patients with complete, partial or no remission on Day 28, 56 and 84
    • Absolute improvement of speech recognition in quiet from baseline to Day 14, 28 and 56
    • Percentage of patients eligible for salvage therapy
    • Improvement of scoring in HHIA from baseline to Day 28 and 84
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Poland
    Bulgaria
    Netherlands
    Czechia
    Germany
    Russian Federation
    Serbia
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 210
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the readout of the primary endpoint at Day 28 the investigator is allowed to provide a standard of care salvage therapy if no improvement of hearing was achieved following study treatment.

    After finalization of the follow-up period after Day 84 (= EoT) patients will be referred back to their ENT specialist and treated in accordance with standard therapies in the country.



    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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