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

  • STATUS
    Recruiting
  • End date
    Jan 6, 2022
  • participants needed
    501
  • sponsor
    AbbVie
Updated on 2 June 2021
Investigator
AbbVie_Call Center
Primary Contact
Cardio Alem /ID# 211285 (1.3 mi away) Contact
+730 other location
corticosteroids
endoscopy
immunosuppressive agents
abdominal pain
conventional treatment
crohn's disease
mucosal inflammation

Summary

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).

Details
Condition Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), crohns disease
Treatment Upadacitinib, Placebo for Upadacitinib
Clinical Study IdentifierNCT03345849
SponsorAbbVie
Last Modified on2 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 one or more conventional and/or biologic 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)
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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