The research study is testing an investigational product called TAVO101 designed specifically for people diagnosed with moderate to severe atopic dermatitis (eczema),
TAVO101 is a monoclonal antibody which is a large protein that binds to substances in the body and mimics the immune system’s usual response to these substances. TAVO101 is administered intravenously (into a vein with a needle). The main purpose of this research study is to learn if TAVO101 can help potentially reduce itching, redness, and improve skin health.
Anticipated date enrolment will close: November 2024
Study duration
Participants will receive either CagriSema or Mounjaro® tirzepatide and inject once weekly for up to 68 weeks.
Who can take part
This trial might be right for you if you:
- Are 18 to 75 years of age (inclusive)
- A diagnosis of moderate to severe atopic dermatitis for at least 6 months
- Able to attend RMH for site visits for intravenous infusions
You may not be able to participate if you:
- Are taking concurrent treatment with other eczema medications
- Are pregnant, or planning to become pregnant, or breastfeeding during the study
What's involved
- Attend the RMH in Parkville about 8 times over the 6-month trial period. Depending on the study medication assignment, participants receive 2-3 infusions during the study period.
- Most study visits with infusions should take about 5-6 hours.
- Medical history, physical examination, height, and weight
- Provide blood and urine samples
- Perform ECG test
- Daily eDiary completion
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.