M14-431 U-EXCEED: A Study of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease (H-42657)
M14-431 U-EXCEED- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy.
The purpose of this study is to evaluate the safety of upadacitinib and determine how well it works, as well as the pharmacokinetics (PK) (how drug is absorbed, distributed, and eliminated in the body over time) of upadacitinib in subjects with moderate to severe Crohn’s Disease.
Inclusion / exclusion criteria. You may qualify for this study if:
- You are a male or a female between the ages of 18 and 75.
- You have an established diagnosis of Crohn’s Disease (CD) at least 3 months prior to enrollment.
- You are experiencing symptoms of abdominal pain and/or diarrhea.
- You are unable to tolerate or have had insufficient response to previous treatment with biologic medications such as infliximab, adalimumab, vedolizumab, certolizumab , ustekinumab.