What is the mechanism of action of this treatment?

Topical antifungal agents, such as those being studied in the trial MOB015B, work by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes. This disruption in cell membrane integrity leads to the death of the fungal cells. For patients with fungal nail infections, this mechanism is particularly important as it allows for direct application to the affected area, reducing systemic side effects and providing a safer long-term treatment option compared to oral antifungals.

What side effects are associated with this type of intervention?

Common side effects of topical antifungal treatments for fungal nail infections, such as ciclopirox, efinaconazole, and tavaborole, include local skin irritation, redness, itching, and burning at the application site. These side effects are generally mild and temporary. In rare cases, patients may experience allergic reactions, which can manifest as severe itching, rash, or swelling. It is important to follow the prescribed application instructions and consult a healthcare provider if severe or persistent side effects occur.

What prior FDA approvals exist?

The FDA has approved several treatments for fungal nail infections (onychomycosis), including both oral and topical antifungal agents. Topical treatments similar to MOB015B include efinaconazole (Jublia) and tavaborole (Kerydin), which are applied directly to the affected nails. These treatments work by inhibiting fungal growth and are typically used for mild to moderate cases of onychomycosis. Oral antifungal agents such as terbinafine (Lamisil) and itraconazole (Sporanox) are also FDA-approved and are often prescribed for more severe infections. These medications require a longer treatment duration and have a higher risk of systemic side effects compared to topical treatments.

What other types of research exist?

Promising alternatives to MOB015B for fungal nail infections include: 1) Topical terbinafine 10% solution, which has shown efficacy in clinical trials. 2) Sequential pulse therapy with itraconazole and terbinafine, which has demonstrated effectiveness in a 72-week study. 3) Ustekinumab, an immunomodulatory agent, has shown efficacy in nail psoriasis and may offer benefits for fungal nail infections. Patients should discuss these options with their healthcare provider to determine the best treatment plan.

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Antifungal

Topical MOB015B for Fungal Nail Infection

Phase 3

Waitlist Available

Research Sponsored by Moberg Pharma AB

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 week

Awards & highlights

Pivotal Trial

Summary

This trial tests MOB015B, a new topical treatment for nail fungus, on patients with DSO. The treatment uses an antifungal ingredient to kill the fungi and is applied regularly over several months.

Who is the study for?

This trial is for people aged 12 to 75 with a fungal nail infection affecting 20-60% of their great toenail, who can cut their nails monthly. They must have a positive test for dermatophytes but no other infections or conditions like psoriasis that affect the nail's appearance. Pregnant women and those on recent antifungal treatments are excluded.

What is being tested?

The study tests MOB015B, a topical treatment for toenail fungus, against a placebo (vehicle). It's double-blind, meaning neither participants nor researchers know who gets the real treatment versus the placebo until after results are collected.

What are the potential side effects?

While specific side effects aren't listed here, typical ones from topical antifungals include skin irritation, redness, itching or burning at the application site. Systemic side effects are rare since it's applied locally.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a fungal nail infection affecting 20% to 60% of at least one big toenail.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known immune system problem or take medication that affects my immune system.

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I have not been in a drug or device trial in the last 3 months.

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I have very weak or no pulse in my feet.

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My toenail infection is not caused by dermatophyte fungi.

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I am not pregnant, breastfeeding, nor planning to become pregnant within the next year.

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I have or had psoriasis or lichen planus.

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I have a severe fungal infection or splitting in my toenail.

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I have had toenail surgery in the last 6 months that affects how my nail grows.

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I have nail conditions that could hide nail clearing.

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My diabetes is not well-controlled, with an HbA1c over 8%.

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My toenail fungus has spread close to the base of my nail.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (Safety)

Proportion of subjects with complete cure of the target toenail

Secondary study objectives

Proportion of subjects with mycological cure of target toenail

Proportion of subjects with treatment success of target toenail

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MOB015BExperimental Treatment1 Intervention

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

Group II: Control ArmPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MOB015B

2017

Completed Phase 3

~1140

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Topical antifungal agents, such as those being studied in the trial MOB015B, work by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes. This disruption in cell membrane integrity leads to the death of the fungal cells. For patients with fungal nail infections, this mechanism is particularly important as it allows for direct application to the affected area, reducing systemic side effects and providing a safer long-term treatment option compared to oral antifungals.