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

NCT ID: NCT05279846

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2025-01-31

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.

Conditions

Onychomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MOB015B

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

Group Type: EXPERIMENTAL

MOB015B

Intervention Type: DRUG

Applied topically for 48 weeks

Control Arm

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

Group Type: PLACEBO_COMPARATOR

Vehicle (Placebo Comparator)

Intervention Type: DRUG

Applied topically for 48 weeks

Interventions

MOB015B

Applied topically for 48 weeks

Intervention Type: DRUG

Vehicle (Placebo Comparator)

Applied topically for 48 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moberg Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Martin Foot and Ankle

York, Pennsylvania, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

DermResearch, Inc.

Austin, Texas, United States

Futuro Clinical Trials LLC

McAllen, Texas, United States

Progressive Clinical Research, PA

San Antonio, Texas, United States

Houston Center for Clinical Research

Sugar Land, Texas, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Mediprobe Research

London, Ontario, Canada

Toronto Research Centre

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

MOB015B-33-21-001

Identifier Type: -

Identifier Source: org_study_id