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

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)

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Onychomycosis
• Intervention / Treatment: Drug: MOB015B; Drug: Vehicle (Placebo Comparator)

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.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N5X 2P1
      • Mediprobe Research
    • Toronto, Ontario, Canada
      • Toronto Research Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama Hospital
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research,Inc
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • San Francisco, California, United States, 94115
      • Center for Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Olympian Clinical Research
    • Coral Gables, Florida, United States, 33134
      • Driven Research LLC
    • South Miami, Florida, United States, 33143
      • Doctors Research Institute Corporation
  • Illinois
    • O'Fallon, Illinois, United States, 62269
      • Podiatry 1st
  • Indiana
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • DelRicht Research - Baton Rouge
    • Monroe, Louisiana, United States, 71201
      • IMA Clinical Research
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson, MD, Dermatology, PLLC
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Skin Care Research
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Associated Skin Care Specs
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
  • New York
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group
    • New York, New York, United States, 10021
      • Weill Cornell Medicine Dermatology
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • UNC Dermatology and Skin Cancer Center
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Haber Dermatology, Inc.
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Department of Dermatology
    • York, Pennsylvania, United States, 17402
      • Martin Foot and Ankle
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • McAllen, Texas, United States, 78501
      • Futuro Clinical Trials LLC
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research, PA
    • Sugar Land, Texas, United States, 77479
      • Houston Center for Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOB015B; Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks	Drug: MOB015B; Applied topically for 48 weeks
Placebo Comparator: Control Arm; Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks	Drug: Vehicle (Placebo Comparator); Applied topically for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with mycological cure of target toenail	Defined as negative fungal culture of dermatophytes and negative direct KOH microscopy)	52 Week
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

Collaborators and Investigators

• Sponsor: Moberg Pharma AB

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Terbinafine; Antifungal; Nail Fungus; Distal Subungual Onychomycosis (DSO)
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: MOB015B-33-21-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No