A Double-blind, Vehicle-controlled Study of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3 multicenter, double blind study to evaluate the safety and efficacy of vehicle-controlled topical MOB015B in the treatment of Distal Subungual Onychomycosis (DSO)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Moberg Pharma AB
• Collaborator: IQVIA Biotech

Criteria

Inclusion Criteria:

1. Male or females 12 to 75 years of age

2. Distal subungual onychomycosis of at least one of the great toenail(s) affecting 20% to 60% of the target toenail (verified by a central blinded assessor before randomization)

3. Positive KOH microscopy and culture for dermatophytes in the target toenail

4. Ability of the great toenail to grow (e.g., subject reports cutting toenails at least monthly)

5. Signed written informed consent/assent

Exclusion Criteria:

1. Proximal subungual onychomycosis, superficial white onychomycosis, or dystrophic nail, as judged clinically by the blinded assessor or by the Investigator

2. Distal subungual onychomycosis where disease involvement has extended into the proximal portion of the target toenail and the unaffected proximal nail is less than 3 mm measured from proximal nail fold

3. Target toenail thickness more than 3 mm measured at the distal end

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) or severe onychorrhexis on the target toenail

6. Nail conditions other than DSO that are known to cause abnormal nail appearance, presence of melanonychia or subungual hematoma that could obscure visualization of nail clearing

7. Mixed nail infections of the target toenail, for example, candida or mold infections superimposing on dermatophyte infection

8. Previous target toenail surgery (within 6 months) with any residual disfigurement that will impact efficacy outcome or will not allow nail to grow normally, as judged by the Investigator

9. Topical treatment of the toenails with other antifungal medication within 6 weeks before Screening/Visit 1

10. History of failing oral therapy for onychomycosis within the past 3 years, or inability for nail to appear normal due to trauma, as judged by the Investigator

11. Systemic use of antifungal treatment within 6 months before Screening/Visit 1

12. Severe moccasin tinea pedis will be an exclusion criterion. However, subjects with symptomatic interdigital tinea pedis will be allowed to enter the study after appropriate treatment and washout period as per Investigator judgment

13. Signs of severe peripheral circulatory insufficiency as determined by significantly diminished/lack of pedal pulse on either foot

14. Subjects with a current or past history of psoriasis and/or lichen planus

15. Subjects with poorly controlled (or uncontrolled) diabetes mellitus as determined by HbA1c of > 8%

16. Known immunodeficiency, i.e., congenital immunodeficiency, acquired immunodeficiency, iatrogenic by immunosuppressive drugs like cytostatics or by radiation therapy or immunomodulatory medications (e.g., TNF inhibitors)

17. Participation in another clinical trial with an investigational drug or device during the previous 3 months before enrollment/baseline and for the duration of this study

18. Known allergy to any of the tested treatment products

19. Female subjects who are pregnant or breastfeeding; or intend to conceive a child during the duration of the study (52 weeks).

20. Female subjects of childbearing potential who are not using or do not plan on using any birth control measure for the duration of the study

21. Subjects previously randomized to any study involving MOB015B treatment/exposure

22. History of, or current drug or alcohol abuse that would interfere with a subject's ability to participate in the trial as determined by the Investigator

23. Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the subject's ability to completely understand the consequences of consent is missing

24. Close affiliation with the Investigator (e.g., a close relative) or persons working at a study site, or subject who is an employee of the Sponsor's company

25. Subjects who are institutionalized because of legal or regulatory order

26. Any diseases or circumstances in which the subject should not participate in the study in the opinion of the Investigator