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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
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
AK120
2023
Completed Phase 2
~180
Placebo
1995
Completed Phase 3
~2670
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.
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.
Find a Location
Who is running the clinical trial?
Akesobio Australia Pty LtdLead Sponsor
9 Previous Clinical Trials
723 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with chronic atopic dermatitis for at least 1 year.It seems like there might be some information missing from your request. Could you please provide more details or clarify the criterion you would like me to summarize?You have severe eczema covering a large part of your body.You have a certain level of severity in eczema symptoms and affected skin area.You have had tuberculosis (TB) in the past or currently have evidence of TB infection.You have used a topical drug treatment in a way that didn’t work well or wasn’t right for your medical condition in the past 6 months.You have tested positive for hepatitis B, hepatitis C, or HIV.You have had a parasite infection in the past or have traveled to an area with a lot of parasites within the last 6 months.You haven't waited long enough after stopping certain medications before starting the study.You have had vernal or atopic keratoconjunctivitis in the last 6 months.You have had chronic atopic dermatitis (AD) for at least 1 year.You are 18 years old or older.You have not responded well to or have used topical medication in a way that wasn't recommended in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: AK120 Regimen 1
- Group 2: AK120 Regimen 2
- Group 3: Placebo to AK120
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT05048056 — Phase 2