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 | 12.1 |
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 this trial is to compare efficacy and safety of two different treatment regimens of topical MOB015 in adults with DSO at 12 months.
The primary efficacy variable is the proportion of patients with mycological cure of target nail, defined as negative fungal culture and negative direct microscopy, at 12 months.
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E.2.2 | Secondary objectives of the trial |
Secondary efficacy variables: Mycological cure of target nail at 1, 3, 6 and 9 months, Negative fungal culture of target nail at 1, 3, 6, 9 and 12 months nail at 1, 3, 6, 9, Negative direct KOH microscopy at 1, 3, 6, 9 and 12 months, Negative fungal culture, negative direct KOH microscopy and physician’s GES = 4 or 5 at 1, 3, 6, 9 and 12 months, Complete cure (negative fungal culture, negative direct KOH microscopy and physician’s GES = 5) at 1, 3, 6, 9 and 12 months, Change from baseline in length of unaffected target nail at 3, 6, 9 and 12 months, Physician´s GES of target nail at 1, 3, 6, 9 and 12 months, Patient´s subjective score of all treated nails (overall assessment) disregarding the little toenail at 1, 3, 6, 9 and 12 months, Terbinafine concentration in nail at 1, 3 and 6 months, Terbinafine concentration in plasma at 1 month |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female 2. 18 – 70 years 3. DSO of at least one of the great toe(s) affecting 25% to 75% 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 |
Exclusion criteria: 1. Proximal subungual onychomycosis 2. DSO 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 demarcated and localised 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 antifungal treatment of the nails 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. A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (Visit 1) 13. Preāmenopausal (last menstruation ≤ 1 year prior to screening) sexually active women who: - are pregnant or nursing - are not surgically sterile - are of child bearing potential and not practicing an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine devices (IUD), oral, implantable or injectable contraceptives, diaphragm or cervical cap with intravaginal spermicide, condom with intravaginal spermicide or vasectomised partner) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this trial is to compare efficacy and safety of two different treatment regimens of topical MOB015 in adults with DSO at 12 months.
The primary efficacy variable is the proportion of patients with mycological cure of target nail, defined as negative fungal culture and negative direct microscopy, at 12 months. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
3 months treatment and 9 months follow-up compared to 9 months treatment and 3 months follow-up |
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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 | 25 |
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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End of the trial is 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 |