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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, over the age of 18
Chronic atopic dermatitis (AD) diagnosed at least 1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 38
Awards & highlights
Study Summary
This trial is testing a new drug for atopic dermatitis (a skin condition). The study is comparing the new drug to a placebo, and looking at different doses of the drug to see what is most effective.
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.Check my eligibility
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.See study design
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are 18 years old or older.
Select...
You have had chronic atopic dermatitis (AD) for at least 1 year.
Select...
You have not responded well to or have used topical medication in a way that wasn't recommended in the past 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 38
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 38
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response
Secondary outcome measures
Adverse events(AEs)/serious adverse events(SAEs)
Anti-drug antibodies(ADAs)
Change in Body Surface Area (BSA) of AD involvement
+6 moreTrial 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
Find a Location
Who is running the clinical trial?
Akesobio Australia Pty LtdLead Sponsor
9 Previous Clinical Trials
812 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many venues is this experiment being conducted at?
"This clinical trial is administered from numerous sites, including AkesoBio Investigative Site 2003 in Little Rock, Arkansas; AkesoBio Investigative Site 2021 in San Diego, California; and AkesoBio Investigative Site 2004 in Houston, Texas."
Answered by AI
Does AK120 present any tangible risks to people who use it?
"The safety of AK120 has been rated as a 2, suggesting that there is evidence backing its general security but no proof yet proving its efficacy."
Answered by AI
What is the maximum capacity of participants in this clinical study?
"To properly launch this clinical trial, 105 individuals that satisfy the established inclusion criteria are necessary. Akesobio Australia Pty Ltd will be spearheading the research from 2 sites: Little Rock's AkesoBio Investigative Site 2003 and San Diego's AkesoBio Investigative Site 2021."
Answered by AI
Are there any available opportunities for individuals to partake in this clinical trial?
"Per clinicaltrials.gov, this trial is currently in its candidate recruitment stage. It was originally posted on September 30th 2021 and recently edited on July 4th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Nebraska
California
How old are they?
18 - 65
What site did they apply to?
AkesoBio Investigative Site 2001
AkesoBio Investigative Site 2017
AkesoBio Investigative Site 2020
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
Because nothing would happen.
PatientReceived no prior treatments
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