Non-controlled, open-label study to evaluate tolerability, safety, and efficacy of MOB015B solution for external use in the treatment of mild to moderate fungal infection of the nail in subjects aged 6-17 years

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Moberg Pharma AB (publ)

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

18 Oct 2023 → ongoing

Decision date (initial)

2024-07-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513214-34-00

EudraCT number

2022-001797-59

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To examine the efficacy of MOB015B in children based on assessment of treatment success, mycological cure, clinical cure, and complete cure.

Conditions and MedDRA coding

Distal Subungual Onychomycosis

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002984-PIP01-21

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Male or female subjects 6 to 17 years of age (inclusive).
2. 2. Distal subungual onychomycosis of at least one of the great toenail(s) affecting at least 20% of the target nail to a maximum of 50% and at least 3 mm of unaffected proximal nail.
3. 3. Positive culture of dermatophyte and positive KOH microscopy in samples taken from the same great toenail.
4. 4. Signed written informed assent/consent.
5. 5. Evidence of ability of the great toenail to grow (eg, subject reports cutting toenails at least monthly).
6. 6. Able to comply with the study protocol (in the opinion of the investigator).

Exclusion criteria 21

1. 1. Proximal subungual onychomycosis, superficial white onychomycosis, significant dystrophy, severe onychorrhexis, or anatomic abnormalities of the great toenail(s) that in the opinion of the investigator would impair clinical evaluation of onychomycosis.
2. 2. Distal subungual onychomycosis where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 3 mm).
3. 3. Target toenail with greater than 50% disease involvement.
4. 4. Target toenail thickness more than 3 mm.
5. 5. “Spike” of onychomycosis extending to eponychium of the target nail.
6. 6. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
7. 7. Conditions other than distal subungual onychomycosis known to cause abnormal nail appearance, presence of melanonychia or subungual hematoma that could obscure visualization of nail clearing.
8. 8. Other microbial infections of the target toenail, for example, candida or mold infections without isolation of a dermatophyte.
9. 9. Subjects with psoriasis, lichen planus, history of mucocutaneous candidiasis, or other conditions that affect nail appearance and/or growth.
10. 10. Previous target toenail surgery with any residual disfigurement.
11. 11. Topical treatment of the toenails with other antifungal medication within 4 weeks before screening/Visit 1.
12. 12. Use of systemic antifungal treatment within 6 months before screening/Visit 1.
13. 13. History or ongoing/active moderate to severe Moccasin tinea pedis.
14. 14. Having a diagnosis of type 1 diabetes or uncontrolled type 2 diabetes.
15. 15. Known immunodeficiency.
16. 16. Known human immunodeficiency virus (HIV) infection.
17. 17. Participation in another clinical study with an investigational drug or device during the previous 3 months before screening/Visit 1.
18. 18. Known allergy to any of the tested treatment products.
19. 19. A positive pregnancy test at enrollment/baseline (Visit 2).
20. 20. Female subjects physiologically capable of becoming pregnant but are unwilling to refrain from sexual intercourse during the whole study duration or unwilling to use acceptable methods of contraception as agreed with the investigator.
21. 21. Female subjects who are pregnant, breastfeeding mothers, those planning a pregnancy during the study or who become pregnant.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Treatment success (defined as 0-10% clinical disease involvement of the target toenail and mycological cure of target toenail) at Week 48.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Moberg Pharma AB (publ)

Sponsor organisation

Moberg Pharma AB (publ)

Address

Gustavslundsvagen 42 Tr 5, Vasterled Vasterled

City

Bromma

Postcode

167 51

Country

Sweden

Scientific contact point

Organisation

Moberg Pharma AB (publ)

Contact name

Clinical Trial Information Desk

Public contact point

Organisation

Moberg Pharma AB (publ)

Contact name

Clinical Trial Information Desk

Third parties 1

Locations

4 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 26 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications