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

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Onychomycosis

In brief

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)

Key facts

Study ID

NCT05279846

Run by

Moberg Pharma AB

People needed

350

Starts

2022-05-09

Expected to finish

2025-01-01

Last updated by the study team

2024-06-26

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females 12 to 75 years of age
• 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)
• Positive KOH microscopy and culture for dermatophytes in the target toenail
• Ability of the great toenail to grow (e.g., subject reports cutting toenails at least monthly)
• Signed written informed consent and assent (if applicable)

You may not qualify if…

• 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
• 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
• Target toenail thickness more than 3 mm measured at the distal end
• "Spike" of onychomycosis extending to eponychium of the target toenail
• Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin) or severe onychorrhexis on the target toenail
• 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
• Other microbial infections of the target toenail, for example, candida or mold infections without isolation of a dermatophyte
• 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
• Topical treatment of the toenails with other antifungal medication within 6 weeks before Screening/Visit 1
• 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
• Systemic use of antifungal treatment within 6 months before Screening/Visit 1
• 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.
• Signs of severe peripheral circulatory insufficiency as determined by significantly diminished/lack of pedal pulse on either foot
• Subjects with a current or past history of psoriasis and/or lichen planus
• Subjects with poorly controlled (or uncontrolled) diabetes mellitus as determined by HbA1c of > 8%
• 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)
• 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
• Known allergy to any of the tested treatment products
• Female subjects who are pregnant or breastfeeding; or intend to conceive a child during the duration of the study (52 weeks).
• Subjects previously randomized to any study involving MOB015B treatment/exposure
• 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
• 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
• 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
• Subjects who are institutionalized because of legal or regulatory order
• Any diseases or circumstances in which the subject should not participate in the study in the opinion of the Investigator

Where it is running

• University of Alabama Hospital — Birmingham, Alabama, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Center for Dermatology Clinical Research,Inc — Fremont, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Center for Clinical Research — San Francisco, California, United States
• Colorado Medical Research Center — Denver, Colorado, United States
• Olympian Clinical Research — Clearwater, Florida, United States
• Driven Research LLC — Coral Gables, Florida, United States
• Doctors Research Institute Corporation — South Miami, Florida, United States
• Podiatry 1st — O'Fallon, Illinois, United States
• The South Bend Clinic, LLC — South Bend, Indiana, United States
• DelRicht Research - Baton Rouge — Baton Rouge, Louisiana, United States
• IMA Clinical Research — Monroe, Louisiana, United States
• David Fivenson, MD, Dermatology, PLLC — Ann Arbor, Michigan, United States
• Michigan Center for Skin Care Research — Clinton Township, Michigan, United States
• Associated Skin Care Specs — New Brighton, Minnesota, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• Forest Hills Dermatology Group — Kew Gardens, New York, United States
• Weill Cornell Medicine Dermatology — New York, New York, United States
• Skin Search of Rochester — Rochester, New York, United States
• UNC Dermatology and Skin Cancer Center — Chapel Hill, North Carolina, United States
• Haber Dermatology, Inc. — Beachwood, Ohio, United States
• Oregon Dermatology and Research Center — Portland, Oregon, United States
• UPMC Department of Dermatology — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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