A clinical trial to assess the safety and effectiveness of a new drug called benralizumab for atopic dermatitis (eczema).
About this study
Atopic dermatitis 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 benralizumab 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.
Enrolments have closed.
Who can take part
Inclusion criteria
- Moderate to severe disease as per investigator assessment
- More than 10% of the body affected by atopic dermatitis
- Have used steroid creams within the last 6 months and have had an inadequate response
Exclusion criteria
- Other skin conditions or types of dermatitis that may interfere with study assessments
- Use of medications that suppress the immune system within 3 months of starting trial
What's involved
- Undergo chest x-ray and ECG
- Provide blood/urine samples
- Weight, blood pressure measured
- 16 visits to site
- Skin checks
- Regular injections into the skin
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.