A clinical trial to assess a new drug called amlitelimab (KY1005) as a treatment for moderate to severe atopic dermatitis (eczema)
About this study
Atopic dermatitis, commonly referred to as eczema, is a condition that makes your skin red, itchy and prone to infections. It can be treated with special creams for the skin, tablets or injections.
The investigational drug for this study is called amlitelimab (KY1005) and given as an injection into the skin.
The purpose of this research project is to measure how safe and effective this medication is in treating participants with atopic dermatitis. Prior research studies in humans have shown that this medication may help control the immune system that is responsible for the signs and symptoms of atopic dermatitis and help achieve disease improvement.
Anticipated enrolment close date: January 2023
Who can take part
Inclusion criteria
You may be able to participate in this study if you have:
- Moderate to severe disease as per investigator assessment
- More than 10% of your body is affected by atopic dermatitis
- Used steroid creams within the last 6 months and have had an inadequate response
Exclusion criteria
You cannot participate in this study if you:
- Have other skin conditions or types of dermatitis that may interfere with study assessments
- Use medications that suppress the immune system within 4 weeks of starting trial
- Use dupilimab and other biological medications within 3 months of starting trial
What's involved
- 4 week screening period
- 52-week double-blind treatment period with an extension period
- Regular injections into the skin
- You will need to provide blood/urine samples
- Chest X-ray, weight, blood pressure
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.