M14-431 A Multicenter Randomized Double-Blind Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT 494) in Subject's with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant t

Brief description of study

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. This is a research study of an investigational drug called upadacitinib in subjects with moderately to severely active Crohn’s Disease. An investigational drug is one that has not been approved by the regulatory authorities in your country. This study will collect optional exploratory samples. Exploratory research can help to improve our understanding of how individuals respond to drugs and the ability to predict, detect, and monitor diseases and their progression. The purpose of this research is too find out why some patients with the CD respond better or worse to the study drug or drugs of the same or similar class, and how CD and related conditions develop and progress and how they can be diagnosed, monitored or treated.

Clinical Study Identifier: s17-01251
ClinicalTrials.gov Identifier: NCT03345836
Principal Investigator: Lev Ginzburg.

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