Do you have Ulcerative Colitis and are currently on infliximab?

The BUILD Study – A clinical trial to assess the effectiveness of a new add on therapy to infliximab

The purpose of this research study is to compare the effects of the study drug, PF-06687234, with a placebo while also being treated with infliximab to find out which is better for treating Ulcerative Colitis (UC).

The study drug, PF-06687234 has two proteins that are connected to each other. One protein seeks out and attaches to areas of inflammation (for example the colon in UC).  The second protein works to “calm down” the immune system in inflamed areas such as the colon, in UC. A placebo looks like the study drug but does not contain any active drug. Researchers use a placebo to see if the study drug works better or is safer than not taking anything.

PF-06687234 is an experimental drug which means that it is not an approved treatment for UC in Australia.

Last date that enrolment will close: December 2020

Who can take part

Inclusion

  • Histological diagnosis of Ulcerative Colitis
  • Only partial response to Infliximab, therefore not in remission from disease

Exclusion

  • Pregnant
  • Diagnosis or history of Colectomy, pouchitis, indeterminate colitis microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, or clinical findings suggestive of Crohn’s disease (eg, fistulae, granulomas on biopsy).
  • Known colonic stricture, or history of colonic or small bowel obstruction or resection.

What is involved for you

Medical History, Physical Exam, Electrocardiogram (ECG), Weight, Height, Blood Pressure, Pulse, Heart Rate, Health Questionnaires, Blood Samples, Urine Test, Colonoscopy with biopsy collection, Stool Tests

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Non-Drug
Phase 1
Phase 2
Phase 3
Phase 4

For more information

Quote reference number
2017.289
Nicola Dalgliesh
03 9342 8441
Zafirah Khan
03 9342 8995