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

June 25, 2024 updated by: Moberg Pharma AB

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects with complete cure of the target toenail
Time Frame: 52 Week
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)
Time Frame: 52 Week
Safety as determined by the incidence of adverse events (AEs)
52 Week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects with mycological cure of target toenail
Time Frame: 52 Week
Defined as negative fungal culture of dermatophytes and negative direct KOH microscopy)
52 Week
Proportion of subjects with treatment success of target toenail
Time Frame: 52 Week
Defined as nails that are "completely clear" or "almost clear" of clinical diseases and negative mycology
52 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Moberg Pharma AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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