Topical MOB015B for Fungal Nail Infection

Not currently recruiting at 37 trial locations

Overseen By Amir Tavakkol, Ph.D.,Dip. Bact

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Moberg Pharma AB

Must not be taking: Antifungals, Immunosuppressants

Disqualifiers: Psoriasis, Diabetes, Immunodeficiency, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new topical treatment called MOB015B for fungal nail infections, specifically targeting Distal Subungual Onychomycosis (DSO) in toenails. The goal is to assess the safety and effectiveness of this treatment compared to a placebo (inactive substance). Participants will apply the treatment at bedtime for a set period to combat the infection. The trial seeks individuals with a confirmed fungal infection in at least one big toenail, where the infection covers 20% to 60% of the nail, and who can cut their toenails at least once a month. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the chance to contribute to the development of a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used topical antifungal treatments on your toenails within 6 weeks before the study or systemic antifungal treatments within 6 months before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that MOB015B, a solution applied to the skin for treating nail fungus, has been tested for safety and effectiveness. In earlier studies, most participants tolerated MOB015B well, and no serious side effects were reported. Some studies found it both safe and effective for treating nail infections.

MOB015B contains terbinafine, an antifungal ingredient used in other treatments, providing extensive safety data. Although specific safety data for MOB015B is not available in the sources, the treatment is in the late stages of testing. This indicates that earlier studies found it safe enough for broader testing.

Overall, research suggests that MOB015B is safe for treating fungal nail infections, with few reported side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for fungal nail infection?

MOB015B is unique because it offers a topical solution for fungal nail infections, which traditionally rely on oral antifungal medications like terbinafine or itraconazole that can have systemic side effects. Unlike these oral treatments, MOB015B is applied directly to the affected area, which may reduce the risk of side effects and potentially improve patient compliance. Researchers are excited because MOB015B combines a new delivery method with a well-known antifungal agent, aiming to enhance treatment effectiveness while minimizing adverse reactions.

What evidence suggests that MOB015B might be an effective treatment for fungal nail infection?

In this trial, participants will receive either MOB015B or a placebo. Studies have shown that MOB015B, which contains the antifungal ingredient terbinafine, effectively treats nail fungus. Research indicates that this topical solution has a good safety profile, causing fewer side effects than other treatments. Importantly, MOB015B penetrates the affected nail better than oral terbinafine, potentially leading to better treatment results. However, one study found that MOB015B did not achieve its main goal when used daily for 8 weeks. Despite this, its ability to reach infected areas more effectively than oral options suggests it could be a promising treatment for fungal nail infections. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I cut my toenails at least once a month.

Signed written informed consent and assent (if applicable)

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

Exclusion Criteria

Known allergy to any of the tested treatment products

You have participated in a previous study involving MOB015B treatment.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical MOB015B or placebo daily for 8 weeks, then once weekly for 40 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MOB015B
• Placebo
• Vehicle

Trial Overview 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.

How Is the Trial Designed?

Group I: MOB015B Experimental Treatment 1 Intervention

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

Group II: Control Arm Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Moberg Pharma AB

Lead Sponsor

Trials

14

Recruited

2,100+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32585278/

Efficacy and safety of topical terbinafine 10% solution ... MOB-015 is a treatment option for onychomycosis with an adverse event profile similar to vehicle.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05279846

A Vehicle-controlled Study of Topical MOB015B in the ... MOB015B is a newly developed topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. All ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10941855/

Treatment Options for Onychomycosis: Efficacy, Side ... Plasma therapy is a newly investigated, effective, non-invasive treatment for onychomycosis with an ongoing clinical trial study. ... nail clearance results alone ...

4. journals.asm.org journals.asm.org/doi/10.1128/aac.00682-24

Systemic absorption and safety of topical terbinafine ... In another study, MOB015B was shown to have greater target tissue bioavailability compared with oral terbinafine with significant penetration of ...

5. mobergpharma.com mobergpharma.com/press-releases/2024-12-10/moberg-pharma-reports-topline-data-north-american-phase-3-study-and-will

Moberg Pharma reports topline data in the North American ... Moberg Pharma AB (OMX: MOB) announces that MOB-015 (topical terbinafine) did not meet the primary endpoint in the phase 3 study using 8 weeks of daily dosing.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39158295/

a phase 1 maximal usage trial in patients with moderate-to- ... In this study, we assess the safety, tolerability, systemic exposure, and pharmacokinetic characteristics of topical terbinafine hydrochloride 10% solution ( ...

7. jaad.org jaad.org/article/S0190-9622(15)00664-7/fulltext

An open, single-center pilot study of efficacy and safety ... Conclusion: MOB015B was in this study found to be efficacious and safe in the topical treatment of distal subungual onychomycosis. High concentrations of ...

8. withpower.com withpower.com/trial/phase-3-onychomycosis-3-2022-c1c18

Topical MOB015B for Fungal Nail Infection Is MOB015B safe for treating fungal nail infections? There is no specific safety data available for MOB015B in the provided research articles. How ...