A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

  • End date
    Oct 7, 2021
  • participants needed
  • sponsor
Updated on 22 December 2020
AbbVie_Call Center
Primary Contact
Universitaetsklinikum Erlangen /ID# 203551 (8.7 mi away) Contact
+686 other location
abdominal pain
crohn's disease
certolizumab pegol
mucosal inflammation


The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

Treatment Upadacitinib, Matching placebo for upadacitinib
Clinical Study IdentifierNCT03345836
Last Modified on22 December 2020

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Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Crohn's Disease (Pediatric) or Inflammatory bowel disease or Crohn's Disease?
Do you have any of these conditions: Crohn's Disease or crohns disease or Inflammatory bowel disease or Crohn's Disease (Pediatric)?
Do you have any of these conditions: Crohn's Disease or Crohn's Disease (Pediatric) or Inflammatory bowel disease or crohns disease?
Do you have any of these conditions: Crohn's Disease (Pediatric) or crohns disease or Crohn's Disease or Inflammatory bowel disease?
Do you have any of these conditions: crohns disease or Crohn's Disease or Crohn's Disease (Pediatric) or Inflammatory bowel disease?
Confirmed diagnosis of CD for at least 3 months prior to Baseline
Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score
Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader
Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab
If female, participant must meet the contraception recommendations

Exclusion Criteria

Participant with a current diagnosis of ulcerative colitis or indeterminate colitis
Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX)
Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study
Participant with ostomy or ileoanal pouch
Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome
Screening laboratory and other analyses show abnormal results
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Step 4 Get your study results

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