We are looking for people with Crohn's disease to participate in a study to determine the safety and effectiveness of a new study medication, guselkumab.
About this study
Guselkumab is made in the laboratory and is a fully human monoclonal antibody. An antibody is something that targets and kills foreign objects in the body – in this case, small proteins that are released by cells and affect the behaviour of other cells.
This antibody, guselkumab, recognizes and blocks a specific small protein, IL-23, which is important in immune and inflammatory processes.
Anticipated enrolment close date: 31 December 2022
Who can take part
- Crohn’s disease for at least 3 months
- Symptomatic stricture
- Current abscess
- Bowel resection in last 6 months
- Draining stoma or ostomy
What is involved for you
- Medical history
- Physical exam
- Electrocardiogram (ECG)
- Blood pressure
- Heart rate
- Health questionnaires
- Blood samples
- Urine test
- Colonoscopy with biopsy collection
- Stool tests
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.