What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical immunotherapy, vitamin D supplementation, probiotics, and medications like JAK inhibitors and anti-IL-31 antibodies. Topical immunotherapy can cause mild dermatitis. Vitamin D supplementation is generally safe but may cause mild gastrointestinal issues. Probiotics have a good safety profile but can occasionally lead to mild digestive disturbances. JAK inhibitors may cause nasopharyngitis and headache, while anti-IL-31 antibodies like nemolizumab can lead to mild adverse events such as exacerbation of atopic dermatitis.

What prior FDA approvals exist?

FDA-approved treatments for Atopic Dermatitis include topical corticosteroids, which reduce inflammation and immune response, and topical calcineurin inhibitors like tacrolimus and pimecrolimus, which inhibit T-cell activation. Crisaborole, a nonsteroidal phosphodiesterase 4 inhibitor, is another topical option that reduces inflammation. For moderate-to-severe cases, dupilumab, a monoclonal antibody targeting the IL-4 receptor, has been approved to modulate the immune response. These treatments address various aspects of the inflammatory pathways involved in AD.

What other types of research exist?

Promising novel alternatives for Atopic Dermatitis treatment in 2024 include AK120, currently in phase 2 trials, and upadacitinib, which has shown efficacy in a randomized, placebo-controlled trial. Both treatments are being studied for their potential to manage moderate-to-severe AD.

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Unknown

AK120 for Atopic Dermatitis

Phase 2

Waitlist Available

Research Sponsored by Akesobio Australia Pty Ltd

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new treatment called AK120 for adults with moderate-to-severe atopic dermatitis. The study aims to see if AK120 can help reduce symptoms of this skin condition. Researchers will also look at how the treatment moves through and affects the body, as well as its safety.

Who is the study for?

Adults over 18 with chronic atopic dermatitis diagnosed for at least a year, having moderate-to-severe symptoms (EASI score ≥16, IGA ≥3), and covering more than 10% of body surface. Participants should have tried topical treatments without success in the past 6 months. Excluded are those with TB, hepatitis B/C, HIV, recent parasite infections or travel to high-risk areas, inadequate prior drug washout periods, certain eye conditions (VKC/AKC), or any condition that could risk safety or study integrity.

What is being tested?

The trial is testing AK120's effectiveness and safety against a placebo in adults with moderate-to-severe atopic dermatitis. It's a phase 2 study where participants are randomly assigned to receive either AK120 or a placebo in a double-blind setup—meaning neither the researchers nor the participants know who gets which treatment until after the results are collected.

What are the potential side effects?

While specific side effects of AK120 aren't listed here, common side effects for treatments like this can include skin irritation or redness where applied, itching beyond usual eczema symptoms, potential allergic reactions if sensitive to ingredients in AK120 and general discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Group I: Placebo to AK120Experimental Treatment2 Interventions

Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation

Group II: AK120 Regimen 2Experimental Treatment1 Intervention

AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks.

Group III: AK120 Regimen 1Experimental Treatment1 Intervention

AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

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

The most common treatments for Atopic Dermatitis (AD) include topical corticosteroids, topical calcineurin inhibitors, and phototherapy. Topical corticosteroids reduce inflammation and suppress the immune response, providing relief from itching and redness. Topical calcineurin inhibitors, such as tacrolimus and pimecrolimus, inhibit calcineurin, a protein involved in the activation of T-cells, thereby reducing inflammation and immune activity without the side effects associated with steroids. Phototherapy, using narrow-band UV-B or UV-A1 light, helps to reduce skin inflammation and can modulate the immune response. These treatments are crucial for AD patients as they help manage symptoms, reduce flare-ups, and improve the quality of life by addressing the underlying inflammatory processes.

European guideline (EuroGuiDerm) on atopic eczema - part II: non-systemic treatments and treatment recommendations for special AE patient populations.A systematic review of evidence based treatments for lichen simplex chronicus.Lip Injection Techniques Using Small-Particle Hyaluronic Acid Dermal Filler.