Despite advancements in IBD treatments, up to 80 percent of patients will never achieve full disease remission.i In fact, many patients face rapid disease progression early in their treatment course due to ineffective or delayed therapies,ii which can result in irreversible gastrointestinal (GI) damage and potential surgery.iii
"Due to the complex nature and multifactorial causes of IBD, it can be challenging to predict which patients need and will respond to early advanced treatments," said
"The personalized study design of the INTREPID and EXPEDITION research programs reflect
More about INTREPID and EXPEDITION
INTREPID is a patient-centric Phase 2b/3, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group, Crohn's disease program. In Stage 1 (Phase 2b), brazikumab will be compared to placebo and HUMIRA® (adalimumab) and in Stage 2 (Phase 3) brazikumab will be compared to HUMIRA® only. Approximately 450 patients will be enrolled in Stage 1 and 690 patients in Stage 2. To the benefit of study participants, all will have post-trial access to study treatments.
EXPEDITION is starting with a Phase 2, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group, study of patients with ulcerative colitis. The safety and efficacy of brazikumab will be compared to placebo or ENTYVIO® (vedolizumab). Approximately 375 patients will be enrolled. Biomarker learnings from this study will be applied to the planned Phase 3 part of the program.
The primary endpoints of INTREPID include evaluations of endoscopic response and clinical remission based on loose stool frequency and abdominal pain scores.The primary endpoints of EXPEDITION include evaluations of endoscopic response and clinical remission based on loose stool frequency and rectal bleeding. In both programs, patients who previously received standard biologic therapy (biologic-intolerant or -refractory) and those who were never treated with biologic therapy (biologic-naïve) will be enrolled. Patients who received conventional therapies, such as corticosteroids or immunomodulators, will also be included. Where available, participants will have access to study treatments after the programs are completed until brazikumab is commercially available or
More about IBD
Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, causes chronic inflammation in the GI tract. Crohn's disease can affect any part of the GI tract, from the mouth to the anus. Ulcerative colitis, however, only affects the large intestine (colon) and the rectum.
The exact causes of IBD are not fully understood.ii It is a complex disease involving multiple genetic, immune system and environmental factors that can lead to poor quality of life and high economic and personal costs.ii
More about Allergan Gastroenterology
In addition to INTREPID and EXPEDITION,
Learn more at AllerganGastroenterology.com.
About
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect
i Feldman, P. A., Wolfson, D., & Barkin, J. S. (2007). Medical Management of Crohn's Disease. Clinics in Colon and Rectal Surgery, 20(4), 269–281. http://doi.org/10.1055/s-2007-991026
ii Facts about Inflammatory Bowel Diseases. (2011,
iii Lichtenstein, Gary R. et al. (2018). "ACG Clinical Guideline: Management of Chron's Disease in Adults."
iv Sands, Bruce E. et al. (2017). Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients with Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology, Volume 153, Issue 1, 77 - 86.e6
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