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

NCT05279846 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: MOB015B-33-21-001
• Study Type: interventional
• Target: 350
• Locations: 2 countries
• Sites: 35

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)

Conditions

Onychomycosis

Keywords

Nail Fungus; Antifungal; Terbinafine; Distal Subungual Onychomycosis (DSO)

Outcome Measures

Primary Outcomes (2)

• 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

• Incidence of adverse events (Safety)

  Safety as determined by the incidence of adverse events (AEs)

  52 Week

Secondary Outcomes (2)

• Proportion of subjects with mycological cure of target toenail

  52 Week

• Proportion of subjects with treatment success of target toenail

  52 Week

Study Arms (2)

MOB015B

EXPERIMENTAL

Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks

Drug: MOB015B

Control Arm

PLACEBO COMPARATOR

Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks

Drug: Vehicle (Placebo Comparator)

Interventions

MOB015B DRUG

Applied topically for 48 weeks

MOB015B

Vehicle (Placebo Comparator) DRUG

Applied topically for 48 weeks

Control Arm

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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%

Sponsors & Collaborators

• Moberg Pharma AB: lead

Study Sites (35)

University of Alabama Hospital

Birmingham, Alabama, 35233, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Center for Dermatology Clinical Research,Inc

Fremont, California, 94538, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Center for Clinical Research

San Francisco, California, 94115, United States

Location

Colorado Medical Research Center

Denver, Colorado, 80210, United States

Location

Olympian Clinical Research

Clearwater, Florida, 33756, United States

Location

Driven Research LLC

Coral Gables, Florida, 33134, United States

Location

Doctors Research Institute Corporation

South Miami, Florida, 33143, United States

Location

Podiatry 1st

O'Fallon, Illinois, 62269, United States

Location

The South Bend Clinic, LLC

South Bend, Indiana, 46617, United States

Location

DelRicht Research - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

IMA Clinical Research

Monroe, Louisiana, 71201, United States

Location

David Fivenson, MD, Dermatology, PLLC

Ann Arbor, Michigan, 48103, United States

Location

Michigan Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

Location

Associated Skin Care Specs

New Brighton, Minnesota, 55112, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Forest Hills Dermatology Group

Kew Gardens, New York, 11415, United States

Location

Weill Cornell Medicine Dermatology

New York, New York, 10021, United States

Location

Skin Search of Rochester

Rochester, New York, 14623, United States

Location

UNC Dermatology and Skin Cancer Center

Chapel Hill, North Carolina, 27516, United States

Location

Haber Dermatology, Inc.

Beachwood, Ohio, 44122, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Martin Foot and Ankle

York, Pennsylvania, 17402, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Futuro Clinical Trials LLC

McAllen, Texas, 78501, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78213, United States

Location

Houston Center for Clinical Research

Sugar Land, Texas, 77479, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Mediprobe Research

London, Ontario, N5X 2P1, Canada

Location

Toronto Research Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 15, 2022
• Study Start: May 9, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (33)