E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Distal Subungual Onychomycosis |
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E.1.1.1 | Medical condition in easily understood language |
Subungual Onychomycosis is a nail fungus |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030338 |
E.1.2 | Term | Onychomycosis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 phase III study is to evaluate the efficacy of topical MOB015B in patients with mild to moderate DSO. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this phase III study is to evaluate the safety of topical MOB015B in patients with mild to moderate DSO. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Males or females 18 – 75 years of age (inclusive) at the time of Informed Consent 2. Distal subungual onychomycosis (DSO) of at least one of the great toenail(s) affecting 20% to 60% of the target nail 3. Positive culture for dermatophytes 4. Signed written informed consent (ICF) prior to any study-related activity
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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 3 mm) 3. Target toenail thickness more than 3 mm 4. ”Spike” of onychomycosis extending to eponychium of the target toenail 5. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail 6. Other conditions than DSO known to cause abnormal nail appearance 7. Presence of toenail infection other than dermatophytes 8. Previous target toenail surgery with any residual disfigurement 9. Topical treatment of the nails with other antifungal medication or medical device within 6 weeks before Screening/Visit 1 10. Systemic use of antifungal treatment within 6 months before Screening / Visit 1 11. Severe moccasin tinea pedis 12. Signs of severe peripheral circulatory insufficiency 13. Uncontrolled diabetes mellitus (blood glucose not adjusted to stable levels despite antidiabetic therapy and / or careful medical monitoring by the family physician / specialist is not ensured) 14. Known immunodeficiency, i.e. congenital immunodeficiency, acquired immunodeficiency (e.g. HIV, some bone marrow diseases, extreme diets), iatrogenic by immunosuppressive drugs like cytostatics or by radiation therapy or immunomodulatory medications (e.g. TNF inhibitors) 15. Participation in another clinical trial with an investigational drug or device during the previous 3 months before Baseline/ Visit 2 16. Known allergy to any of the tested treatment products 17. A positive pregnancy test indicating pregnancy in a woman of childbearing potential* at Baseline/ Visit 2 18. Females who are pregnant or breastfeeding 19. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who: • are of childbearing potential* and are not practicing an acceptable method of birth control**, or do not plan to continue practicing an acceptable method of birth control throughout the trial 20. Patients previously randomized in this study 21. History of, or current drug or alcohol abuse 22. Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the patient’s ability to completely understand the consequences of consent is missing 23. Close affiliation with the investigator (e.g. a close relative) or persons working at a study site, or patient who is an employee of the sponsor’s company 24. Patients who are institutionalized because of legal or regulatory order 25. Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
• Patients with complete cure at Week 52 Complete cure is defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and 0% clinical involvement of the target nail.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Complete cure (negative fungal culture of dermatophytes, negative direct KOH microscopy and 0% clinical disease involvement) of target nail at other time points than the primary endpoint (i.e., Visit 3, 4, 5, and 6) • Mycological cure of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • Negative fungal culture of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • Negative direct KOH microscopy of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • “Completely clear” or “almost clear” target nail (i.e., 0-10% clinical disease involvement of the target nail) during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • Treatment success (defined as “completely clear” or “almost clear” and negative mycology) of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • Patient´s subjective score of all treated nails except the little toenail(s) during the treatment period of the study (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • Patient´s assessment of IMP handling (Visit 3) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Complete Cure at other visits than Week 52 (i.e. Visits 3, 4, 5 and 6 • Mycological cure of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7) • Negative fungal culture of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7) • Negative direct KOH microscopy of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7) •“Completely clear” or “almost clear” target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7) • Treatment success (defined as “completely clear” or “almost clear” and negative mycology) of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7) • Patient´s subjective score of all treated nails except the little toenail(s) at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7) • Patient´s assessment of IMP handling (Visit 3) |
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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 | 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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 47 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 69 |
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 | 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 Study will be determined as Last Visit Last Subject (LVLS) |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |