A clinical trial to assess safety and effectiveness of a new drug for eczema called nemolizumab.
About this study
Atopic dermatitis, often known as eczema, is a chronic, inflammatory skin disorder characterized by flaky skin lesions, intense itch, and a general deterioration in quality of life.
This research study is evaluating a new study drug called nemolizumab, given regularly as an injection under the skin, in patients with moderate to severe atopic dermatitis not adequately controlled with topic corticosteroids. The purpose of this study is to assess the safety and efficacy of nemolizumab compared to placebo.
The study drug is not currently approved for use in Australia. The duration of the study is 48 weeks with the opportunity to enrol in the long-term extension study.
Anticipated enrolment close date: 31 December 2021
Who can take part
Inclusion criteria
People with:
- A confirmed clinical diagnosis of mild to moderate eczema, affecting at least 10% of body surface area
- A diagnosis of eczema for at least 2 years before commencing the study
- Inadequate response to topical steroid creams within the last 6 months before screening visit
Exclusion criteria
People with a history of uncontrolled asthma, chronic bronchitis or COPD
What's involved
- Blood and urine samples
- 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.