ASTRO - A new treatment for ulcerative colitis

Moderately to severely active ulcerative colitis

The purpose of this study is to learn about the safety and effectiveness of an investigational drug called Guselkumab in the treatment of ulcerative colitis. Guselkumab has already been approved by the TGA for the treatment of other inflammatory conditions, and this study aims to learn if it is effective in the treatment of ulcerative colitis as well.

Trial Status
Trial Phase
Phase 3 Drug Trial
Trial contact details
Contact Person
IBD Clinical Trials Unit
What you need to know

Who can take part?

  • People aged 18 – 75
  • Confirmed diagnosis of mild to moderate Ulcerative Colitis at least 12 weeks prior to joining the study
  • Willingness to complete a daily diary
  • Dosage of any current medications for ulcerative colitis are stable


  • Other disease that may impact study (eg Crohn’s disease)
  • Previous surgery for ulcerative colitis
  • Current or recent infection
  • Current immunodeficiency
  • History of cardiac conditions
  • Certain medications may make you ineligible to participate

What is involved for you?

  • Medical history and collection of demographic information
  • Vital signs
  • Electrocardiogram
  • Physical exam
  • Blood and urine tests
  • Pregnancy tests for women of childbearing potential
  • Colonoscopy and biopsy
  • Chest X-ray
  • Daily diary completion
  • Questionnaires
  • Periodic injections of treatment/placebo

Trial dates

March 2023 to March 2024

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