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    Summary
    EudraCT Number:2016-005166-58
    Sponsor's Protocol Code Number:AM-111-CL-15-01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-08
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-005166-58
    A.3Full title of the trial
    Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment (ASSENT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of AM-111 as Sudden Hearing Loss Treatment.
    A.3.2Name or abbreviated title of the trial where available
    ASSENT
    A.4.1Sponsor's protocol code numberAM-111-CL-15-01
    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 SponsorAuris Medical Inc.
    B.1.3.4CountryUnited States
    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 supportAuris Medical Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAuris Medical Ltd.
    B.5.2Functional name of contact pointThomas Meyer
    B.5.3 Address:
    B.5.3.1Street AddressThe Black Church, St. Mary's Place
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code7
    B.5.3.4CountryIreland
    B.5.6E-mailear@aurismedical.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 numberEMEA/OD/013/05
    D.3 Description of the IMP
    D.3.1Product nameAM-111 0.4 mg/mL
    D.3.4Pharmaceutical form Gel for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPAuricular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrimapitide
    D.3.9.2Current sponsor codeXG-102
    D.3.9.3Other descriptive nameD-JNKI-1
    D.3.9.4EV Substance CodeSUB114549
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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 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 numberEMEA/OD/013/05
    D.3 Description of the IMP
    D.3.1Product nameAM-111 0.8 mg/mL
    D.3.4Pharmaceutical form Gel for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPAuricular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrimapitide
    D.3.9.2Current sponsor codeXG-102
    D.3.9.3Other descriptive nameD-JNKI-1
    D.3.9.4EV Substance CodeSUB114549
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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)
    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.
    E.1.1.1Medical condition in easily understood language
    Sudden deafness.
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061373
    E.1.2Term Sudden hearing loss
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss.
    E.2.2Secondary objectives of the trial
    • Evaluation of the dose-response relationship for AM-111 in the recovery of ISSNHL;
    • Assessment of the efficacy of AM-111 in the recovery of speech discrimination (word recognition in quiet);
    • Assessment of the efficacy of AM-111 in achieving complete remission of ISSNHL-related tinnitus;
    • Assessment of the safety and local tolerance of AM-111.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Unilateral ISSNHL with onset within 72 hours prior to study treatment;
    2. Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across those 3 contiguous air conduction audiometric pure tone frequencies that show the highest mean hearing loss compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a pre-existing audiogram for the affected ear not older than 2 years prior to the ISSNHL incident (defined as “pure tone average”, PTA);*
    3. Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conduction thresholds at the pure tone average fre-quencies compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a pre-existing audiogram for the affected ear not older than 2 years prior to the ISSNHL incident;*
    4. Age ≥ 18 years on the day of screening;
    5. Negative urine pregnancy test for women of childbearing potential. Women are not considered to be of childbearing potential if they meet one of the following criteria:
    a. They have had a hysterectomy or tubal ligation at least one cycle prior to signing the Informed Consent Form (ICF) or
    b. They are post-menopausal, with at least one year since their last menstrual period;
    6. Willing and able to attend the trial visits;
    7. Able to read and understand trial documents and follow Investigator and trial personnel instructions during visits, including audiology measurements;
    8. 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;
    9. 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;
    10. Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved ICF.
    * In subjects assessed within the first 24 hours from ISSNHL onset, inclusion criteria 2 and 3 have to be confirmed by a second measure that is conducted, at the earliest, 24 hours after the onset of ISSNHL. This confirmatory assessment will serve as baseline value.
    E.4Principal exclusion criteria
    1. Bilateral ISSNHL;
    2. Acute hearing loss from noise trauma, barotrauma or head trauma;
    3. Air-bone gap greater than 20 dB at the average of 3 contiguous test frequencies below 4 kHz, when the air-bone gap is measurable;
    4. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière’s disease in either ear;
    5. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
    6. Current evidence or history of acoustic neuroma or other retrocochlear damage in the affected ear;
    7. History of otosclerosis in the affected ear;
    8. Suspected perilymph fistula or membrane rupture in the affected ear;
    9. Congenital hearing loss;
    10. History of ISSNHL in the past 2 years;
    11. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;
    12. Radiation therapy in the head and neck area within the past 5 years;
    13. Abnormality of the tympanic membrane in the affected ear that would preclude intratympanic administration;
    14. Any pre-treatment or ongoing treatment for ISSNHL-related hearing loss or tinnitus (except for oral corticosteroid background therapy that was started within 36 hours prior to randomization);
    15. Any other planned pharmacological or non-pharmacological treatment for hearing loss or tinnitus for the duration of the trial;
    16. Any therapy known as ototoxic (e.g. aminoglycosides [systemic or ototopical with middle ear exposure], cisplatin, loop diuretics, quinine etc.) in the 3 months prior to treatment visit;
    17. History within the past 2 years or presence of drug abuse or alcoholism;
    18. Subjects with diagnosed anxiety disorders, psychosis, depression, schizophrenia, attempted suicide or other significant psychiatric conditions that can impact their ability to cooperate and comply with the study protocol;
    19. Subjects who have answered “yes” to Suicidal Ideation question 4 or 5 of the C-SSRS;
    20. Any clinically relevant autoimmune, respiratory, cardiovascular, neurological disorder (except vertigo or tinnitus) or other abnormality that in the opinion of the Investigator may pose a safety risk to a subject in this study, which may confound efficacy or safety assessment, or may interfere with study participation;
    21. Known HIV, hepatitis B or hepatitis C infection, or symptomatic herpes zoster infection;
    22. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
    23. Women of childbearing potential who are unwilling or unable to use an effective method of avoiding pregnancy from screening until the end of the study (FUV4). Effective methods of avoiding pregnancy are contraceptive methods with a Pearl index of less than 1 when used consistently and correctly (including implantable, injectable, oral and transdermal contraceptives, intrauterine devices, diaphragm with spermicide, male or female condoms with spermicide, or cervical cap, or a sterile sexual partner, or being abstinent);
    24. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization (TV).
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    The primary endpoint is the absolute improvement of PTA in dB from baseline to FUV4 based on the average of the three most affected contiguous audiometric test frequencies. Improvement is defined as the baseline PTA value minus FUV4 value (positive numbers indicating improvement).

    Primary safety endpoint:
    Occurrence of clinically relevant hearing deterioration (defined as increase in air conduction hearing threshold ≥ 10 dB at the average of any two contiguous test frequencies) from baseline to FUV3 in the treated ear. The analysis will also be conducted with bone conduction hearing threshold values.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint: Day 91 / FUV4.
    E.5.2Secondary end point(s)
    Main secondary efficacy endpoint:
    • Absolute improvement in WRS(80dB) from baseline to FUV4. An improvement in WRS of at least 15 percentage points is considered clinically relevant.
    Other secondary efficacy endpoints:
    • Absolute improvement in PTA from baseline to FUV1, FUV2 and FUV3;
    • Absolute improvement in WRS(80 dB) from baseline to follow-up visits FUV1, FUV2 and FUV3; and
    • Frequency of complete tinnitus remission in subjects with ISSNHL-related tinnitus at baseline, determined at FUV4. Complete tinnitus remission is achieved when a subject rates both TLQLoudest and TAQWorst as zero, and answers the question about tinnitus presence with “No”.

    Secondary safety endpoints:
    • Occurrence of clinically relevant hearing deterioration in the treated ear (air conduction) from baseline to all FUVs (other than FUV3);
    • Difference in occurrence of clinically relevant hearing deterioration from baseline to all FUVs between treated and untreated contralateral ear;
    • Occurrence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), assessed for causal relationship with respect to:
    o The IMP, and /or
    o The intratympanic IMP administration procedure.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Main secondary endpoint: Day 91 / FUV4.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Belgium
    Canada
    Czech Republic
    France
    Korea, Republic of
    Poland
    Serbia
    United States
    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 years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days14
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 300
    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 end of the trial, the subjects may be treated according to local standard practice.
    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 Decision2017-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-28
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