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

Onychomycosis Clinical Trial

Official title:

A Multi-center, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05279846
• Other study ID #: MOB015B-33-21-001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 9, 2022
• Est. completion date: March 2024

Study information

• Verified date: October 2023
• Source: Moberg Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

Distal subungual onychomycosis (DSO) is the most common form of Onychomycosis, in which fungi invade the underside of the nail plate. The infection may worsen, spread to other uninfected areas or infect other people. Without treatment the disease may have an impact on an individual's quality of life. MOB015B is a newly developed topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. All ingredients in MOB015B have a well-established use in approved pharmaceuticals for dermatological use. The purpose of this study is to evaluate the efficacy and safety of a new reduced dose treatment regimen of MOB015B whereby the investigational medicinal product (IMP) is applied daily for 8 weeks and then reduced to once weekly treatment for 40 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: March 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Males 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 great 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 and assent (if applicable)

Exclusion Criteria:

1. Proximal subungual onychomycosis, superficial white onychomycosis, or significant dystrophy judged clinically by the blinded assessor or by the Investigator that may interfere with clinical evaluation of onychomycosis

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. Other microbial infections of the target toenail, for example, candida or mold infections without isolation of a dermatophyte

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. Moderate to severe moccasin tinea pedis that require prolonged topical antifungal treatment or oral antifungal treatment should be excluded. Subjects with symptomatic interdigital tinea pedis or mild moccasin type tinea pedis will be screen failed. However, However, they will be allowed to enter the study after appropriate effective 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. Subjects previously randomized to any study involving MOB015B treatment/exposure

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

22. 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

23. Close affiliation with the Investigator (e.g., a close relative) or persons working at the same study site, or subject who is an employee of the Sponsor/designee

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

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

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• MOB015B
Applied topically for 48 weeks
• Vehicle (Placebo Comparator)
Applied topically for 48 weeks

Locations

Country	Name	City	State
Canada	Mediprobe Research	London	Ontario
Canada	Toronto Research Centre	Toronto	Ontario
United States	David Fivenson, MD, Dermatology, PLLC	Ann Arbor	Michigan
United States	DermResearch, Inc.	Austin	Texas
United States	DelRicht Research - Baton Rouge	Baton Rouge	Louisiana
United States	Haber Dermatology, Inc.	Beachwood	Ohio
United States	Hassman Research Institute	Berlin	New Jersey
United States	University of Alabama Hospital	Birmingham	Alabama
United States	UNC Dermatology and Skin Cancer Center	Chapel Hill	North Carolina
United States	Olympian Clinical Research	Clearwater	Florida
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	Driven Research LLC	Coral Gables	Florida
United States	Colorado Medical Research Center	Denver	Colorado
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Center for Dermatology Clinical Research,Inc	Fremont	California
United States	Forest Hills Dermatology Group	Kew Gardens	New York
United States	Dermatology Research Associates	Los Angeles	California
United States	Futuro Clinical Trials LLC	McAllen	Texas
United States	IMA Clinical Research	Monroe	Louisiana
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Associated Skin Care Specs	New Brighton	Minnesota
United States	Weill Cornell Medicine Dermatology	New York	New York
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Podiatry 1st	O'Fallon	Illinois
United States	Skin Specialists, PC	Omaha	Nebraska
United States	UPMC Department of Dermatology	Pittsburgh	Pennsylvania
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Skin Search of Rochester	Rochester	New York
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	Center for Clinical Research	San Francisco	California
United States	The South Bend Clinic, LLC	South Bend	Indiana
United States	Doctors Research Institute Corporation	South Miami	Florida
United States	Houston Center for Clinical Research	Sugar Land	Texas
United States	Martin Foot and Ankle	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Moberg Pharma AB

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with complete cure of the target toenail	Defined as negative fungal culture of dermatophytes, negative direct potassium hydroxide [KOH] microscopy and 0% clinical disease involvement	52 Week
Primary	Incidence of adverse events (Safety)	Safety as determined by the incidence of adverse events (AEs)	52 Week
Secondary	Proportion of subjects with mycological cure of target toenail	Defined as negative fungal culture of dermatophytes and negative direct KOH microscopy)	52 Week
Secondary	Proportion of subjects with treatment success of target toenail	Defined as nails that are "completely clear" or "almost clear" of clinical diseases and negative mycology	52 Week