The two clinical trials, INTREPID and EXPEDITION, will evaluate brazikumab therapy in Crohn’s disease and ulcerative colitis, respectively. Disease-specific biomarkers will be monitored to assess the treatment outcome.
EXPEDITION is currently enrolling participants; more information can be found here.
“If we are able to identify whether certain biomarkers can predict a response to treatment, we may be able to select the most appropriate therapy for patients earlier,” Bruce E. Sands, MD, Dr. Burrill B. Crohn Professor of Medicine at Mount Sinai Hospital in New York, said in a press release.
Brazikumab (also known as AMG-139; MEDI-2070) is an anti-inflammatory investigational drug that has the potential to curb inflammation by blocking the proinflammatory molecule interleukin-23.
Patients who have received standard biologic therapy, corticosteroids or immunomodulators and those who have been on any biologic therapy for the treatment of the conditions being studied will be eligible to participate.
INTREPID is a multi-center, Phase 2b/3 randomized trial evaluating brazikumab’s efficacy and safety in patients with Crohn’s disease. In Phase 2b, approximately 450 patients will randomly receive either brazikumab, a placebo or Humira (adalimumab).
In Phase 3, 690 patients will be treated with either brazikumab or Humira (adalimumab). Loose stool frequency and abdominal pain will be evaluated to assess endoscopic response and clinical remission, both of which will serve as the primary outcome of the study.
The company plans to start enrollment for INTREPID in December.
The second clinical trial, EXPEDITION (NCT03616821), will start with a Phase 2 multi-center study of brazikumab for ulcerative colitis. Approximately 375 patients will randomly receive either brazikumab, placebo or Entyvio (vedolizumab). The results from this study will inform the planning of a Phase 3 study.
“The personalized study design of the INTREPID and EXPEDITION research programs reflect Allergan’s commitment to finding new approaches in how we address the needs of patients with our medicines,” said David Nicholson, PhD, chief R&D officer of Allergan. “These programs are part of our growing focus in gastroenterology, which will become even more significant for Allergan in the coming years.”
Brazikumab was originally developed by Amgen and is now licensed to Allergan.
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