Allergan has commenced two clinical research programmes, INTREPID and EXPEDITION, to assess the safety and efficacy of its investigational IL-23 inhibitor therapy called brazikumab for inflammatory bowel disease (IBD).
The multi-centre, randomised, double-blind, double-dummy, placebo-controlled and active-controlled, parallel-group Phase IIb/III INTREPID programme will evaluate brazikumab for Crohn’s disease treatment.
During the first stage of INTREPID, brazikumab will be compared to placebo and Humira (adalimumab) in around 450 patients. In the second stage, the drug will be compared only to Humira in 690 participants.
The trial’s primary endpoints are tracking of endoscopic response and clinical remission depending on loose stool frequency and abdominal pain scores.
EXPEDITION is an ulcerative colitis programme designed to begin with a multi-centre, randomised, double-blind, double-dummy, placebo-controlled and active-controlled, parallel-group Phase II trial.
In this programme, brazikumab will be compared to placebo or Entyvio (vedolizumab) in about 375 subjects. The primary endpoints of EXPEDITION are same as INTREPID, however, the evaluations will be based on loose stool frequency and rectal bleeding.
EXPEDITION is currently enrolling patients, while INTREPID is expected to begin the recruitment in December this year.
Both programmes have a personalised approach and will evaluate the role of biomarkers in predicting treatment response to brazikumab. Observations from the Phase II EXPEDITION trial will be applied to its planned Phase III part.
Allergan chief R&D officer David Nicholson said: “The personalised study design of the INTREPID and EXPEDITION research programmes reflect Allergan’s commitment to finding new approaches in how we address the needs of patients with our medicines.
“These programmes are part of our growing focus in gastroenterology, which will become even more significant for Allergan in the coming years.”
Allergan’s prior Phase II clinical trial of brazikumab demonstrated higher anti-inflammatory response and remission rates in Crohn’s disease patients who had higher levels of a key IBD biomarker compared to those with lower levels.