A trial to evaluate the efficacy and safety of Filgotinib in the induction and maintenance of remission in people with moderately to severely active Crohn’s disease.
About this study
Crohn’s disease is an inflammatory disease of the gastrointestinal tract (digestive tract).
The purpose of this study is to see if filgotinib, an experimental drug, is effective and safe in treating people with moderate to severe Crohn’s disease.
Anticipated enrolment close date: 31 December 2022
Who can take part
People who have been diagnosed with Crohn's disease for at least 6 months who are of reproductive potential and are willing to adhere to specified contraceptive methods
What's involved
- Electrocardiograms (ECGs)
- Vital signs will be taken (blood pressure, respiratory rate, heart rate), height, weight
- Ileocolonoscopy (with biopsies)
- Urine sample
- Stool sample
- Blood samples
- Questionnaires
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.