E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sensorineural hearing loss (SNHL) |
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E.1.1.1 | Medical condition in easily understood language |
Hearing loss due to damage to the hair cells in the cochlea |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040016 |
E.1.2 | Term | Sensorineural hearing loss |
E.1.2 | System Organ Class | 100000004854 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objectives of this trial (Part B) are: 1. Main objective is to establish the efficacy of local treatment with LY3056480 in terms of hearing at 12 weeks; 2. To establish the efficacy of local treatment with LY3056480 in terms of hearing at 6 weeks; 3. To assess the safety and tolerance of local treatment with LY3056480
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female between 18 and 80 years of age; 2. A primary complaint of hearing loss of ≤20 years in duration, the history suggesting this hearing-loss to be of age-related, noise-induced or idiopathic origin; 3. A bilateral, symmetrical (<15 dBHL difference) SNHL with a pure-tone average threshold across the frequencies 0.5, 1, 2, 4 and 8 kHz of between 25 and 60 dBHL with 2 or more frequencies less than 60 dBHL. |
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E.4 | Principal exclusion criteria |
1. Presenting with a primary complaint of tinnitus 2. A ‘true’ air-bone gap ≥15 dBHL in 3 or more contiguous frequencies between 0.5, 1, 2, 4 kHz 3. History of suspected or diagnosed genetic cause of hearing loss 4. Suspected or known diagnosis of inner ear pathology, congenital hearing loss, fluctuating hearing loss, Ménière's disease or secondary endolymphatic hydrops, perilymph fistula, cochlear barotrauma, autoimmune hearing loss, radiation-induced hearing loss, retro-cochlear lesion 5. Evidence of acute or chronic otitis media or otitis externa on examination; or a history of middle ear pathology and/or surgery 6. Any therapy known as ototoxic within 12 months of screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome measure for part B is change in hearing from baseline at week 12 in the treated ear accross three frequencies as measured by pure tone audiometry. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Safety endpoints will be evaluated from baseline up to week 12. |
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E.5.2 | Secondary end point(s) |
Secondary endpoints for Part B are change from baseline to 6 and 12 weeks in hearing, tinnitus, balance, facial nerve function and taste, and occurrence and severity of local and systemic adverse events related to treatment and/or procedure, and clinically significant changes in ECG, vital signs, physical examination findings and laboratory tests. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 6 and 12 weeks after starting the treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |