Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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 protocol pre-specified analyses show abnormal results.
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2021
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT03345836
Start Date
November 29 2017
End Date
August 11 2021
Last Update
August 15 2022
Active Locations (428)
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1
East View Medical Research, LLC /ID# 171133
Mobile, Alabama, United States, 36606
2
CB Flock Research Corporation /ID# 166220
Mobile, Alabama, United States, 36608
3
Delsol Research Management, Ll /Id# 170179
Chandler, Arizona, United States, 85224
4
HonorHealth Research Institute - Shea /ID# 164734
Scottsdale, Arizona, United States, 85258