A study for people with moderate to severe ulcerative colitis

This study evaluates the efficacy and safety of etrolizumab in patients with moderate to severe ulcerative colitis who are refractory to or intolerant of TNF inhibitors

The purpose of this study is to determine whether etrolizumab is a safe and effective treatment for ulcerative colitis in patients with moderately to severely active ulcerative colitis who have previously been treated with a class of drugs called tumour necrosis factor (TNF) inhibitors, which affects the inflammatory response of your body, but unsuccessfully.

Etrolizumab is designed to work by blocking the binding of certain white blood cells (defense cells normally present in the body to fight infection) to the lining of the gastrointestinal tract. By blocking binding of the cells, it is thought to reduce inflammation caused by your ulcerative colitis.

Anticipated date that enrolment will close: 31 December 2018

Who can take part

  • People with a diagnosis of ulcerative colitis established at least 6 months prior to starting study
  • Not taking any anti-TNF therapy for at least 8 weeks
  • Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening
  • Ineffective treatment with, or intolerance to one or more of the following anti-TNF medications within the previous 5 years:
    • Infliximab
    • Adalimumab (Humira)
    • Golimumab
  • ​AND have moderate to severe ulcerative colitis

The presence of any of the following will exclude you from participation

  • Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for ulcerative colitis
  • Past or present ileostomy or colostomy
  • Diagnosis of indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis
  • Diagnosis of toxic megacolon within 12 months of initial screening visit
  • Any diagnosis of Crohn’s disease, past or present fistula or abdominal abscess
  • A history or current evidence of colonic mucosal dysplasia, patients with any stricture (stenosis) of the colon
  • Patients with history or evidence of adenomatous colonic polyps that have not been removed

What is involved for you

  • Fortnightly/monthly injections
  • Vital signs (blood pressure and pulse)
  • Height and weight measurements
  • Blood, urine and stool samples
  • Colonoscopy/sigmoidoscopy (4 times throughout the study)
  • Completion of questionnaires
  • Daily electronic diary
  • ECG
  • Chest X-Ray
check
Non-Drug
Phase 1
Phase 2
Phase 3
Phase 4

For more information

Quote reference number
2014.146
Virginia Bird - Research Manager
03 9342 8995
Zafirah Khan - Research Coordinator
03 9342 7798