Primary Investigator: Faten Aberra, MD, MSCE , Jan-Michael Klapproth, MD
Research Coordinator: Julie Starr
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) 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.
Confirmed diagnosis of CD for at least three months prior to Baseline.
Confirmed diagnosis of moderate to severe CD as assessed by stool frequency(SF), abdominal pain (AP) score.
Demonstrated an inadequate response or intolerance to one or more conventional and/or biological therapies (Oral locally acting steroids, Intravenous or oral corticosteroids, Immunosuppressants), in the opinion of the investigator.
Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease).
Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's Disease (SES-CD) on an endoscopy confirmed by a central leader.
If female, participant must meet the contraception recommendations.
Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
Participant not on stable doses of CD related antibiotics, oral aminosalicytes, corticosteroids or methotrexate (MTX).
Participant with the following known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminate colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
Participant with ostomy or ileonal pouch.
Participant diagnosed with short gut or short bowel syndrome.
Screening laboratory and other analyses show abnormal results.