Clinical trial NCT05279846: A Vehicle-controlled Study of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Onychomycosis
Keywords: Nail Fungus
Antifungal
Terbinafine
Distal Subungual Onychomycosis (DSO)
Lead sponsor: Moberg Pharma AB
Sponsor class: INDUSTRY
First posted: 2022-03-15
Enrollment: 350
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects with complete cure of the target toenail
timeFrame: 52 Week
measure: Incidence of adverse events (Safety)
timeFrame: 52 Week
Secondary outcomes:
measure: Proportion of subjects with mycological cure of target toenail
timeFrame: 52 Week
measure: Proportion of subjects with treatment success of target toenail
timeFrame: 52 Week
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research,Inc
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Francisco
country: United States
facility: Center for Clinical Research
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Driven Research LLC
state: Florida
city: South Miami
country: United States
facility: Doctors Research Institute Corporation
state: Florida
city: O'Fallon
country: United States
facility: Podiatry 1st
state: Illinois
city: South Bend
country: United States
facility: The South Bend Clinic, LLC
state: Indiana
city: Baton Rouge
country: United States
facility: DelRicht Research - Baton Rouge
state: Louisiana
city: Monroe
country: United States
facility: IMA Clinical Research
state: Louisiana
city: Ann Arbor
country: United States
facility: David Fivenson, MD, Dermatology, PLLC
state: Michigan
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: New Brighton
country: United States
facility: Associated Skin Care Specs
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine Dermatology
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester
state: New York
city: Chapel Hill
country: United States
facility: UNC Dermatology and Skin Cancer Center
state: North Carolina
city: Beachwood
country: United States
facility: Haber Dermatology, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Department of Dermatology
state: Pennsylvania
city: York
country: United States
facility: Martin Foot and Ankle
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: McAllen
country: United States
facility: Futuro Clinical Trials LLC
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Sugar Land
country: United States
facility: Houston Center for Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: London
country: Canada
facility: Mediprobe Research
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
Study officials:
References: