E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Distal subungual onychomycosis (DSO) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030338 |
E.1.2 | Term | Onychomycosis |
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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 primary objective of the study is to evaluate the efficacy of topical K101 in adults with distal subungual onychomycosis compared to placebo after 12 months treatment +2 weeks washout.
The primary efficacy variable is the proportion of patients with mycological cure of the target nail (defined as negative fungal culture and negative direct KOH microscopy) at 12 months treatment + 2 weeks washout (visit 12). |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to evaluate the efficacy and safety of K101 compared to placebo.
Secondary efficacy variables: •Mycological cure of target nail at 6 and 15.5 months •Fungal culture of target nail at 6, 12.5 and 15.5 months •Direct KOH microscopy of target nail at 6, 12.5 and 15.5 months •Length of unaffected target nail at 3, 6, 9, 12.5 and 15.5 months •Physician´s Global Evaluation Score (GES) of target nail at 1, 3, 6, 9, 12.5 and 15.5 months •Patient’s subjective score of all treated nails except the little toenail at 1, 3, 6, 9, 12.5 and 15.5 months. •Proportion of patients with complete cure (simultaneous mycological cure and Physician´s GES=5) of target nail at 6, 12.5 and 15.5 months
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female (including fertile women) 2. 18 years or older 3. Distal subungual onychomycosis of at least one of the great toe(s) affecting 20% to 60% of the target nail (verified by blinded assessor before randomization) 4. Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes) 5. Signed written informed consent
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E.4 | Principal exclusion criteria |
1. Proximal subungual onychomycosis 2. Distal subungual onychomycosis of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm) 3. ”Spike” of onychomycosis extending to eponychium of the target nail 4. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail 5. Other conditions than DSO known to cause abnormal nail appearance 6. Topical treatment of the nails with other antifungal medication within 1 month before screening 7. Systemic use of antifungal treatment within 3 months before screening 8. Signs of severe peripheral circulatory insufficiency 9. Immunosuppression 10. Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening 11. Known allergy to any of the tested treatment products 12. Subject who has been previously randomized to treatment in the phase III study K70-2 investigating K101
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the proportion of patients with mycological cure of the target nail (defined as negative fungal culture and negative direct KOH microscopy) at 12 months treatment + 2 weeks washout (visit 12).
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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 | Yes |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 30 |
E.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |