Status:
COMPLETED
A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
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 adults with moderately and severely active Crohn's disease (CD).
Detailed Description
This study includes two parts: * Part 1: a randomized double-blind placebo-controlled induction period and * Part 2: an extended treatment period for non-responders from Part 1. In Part 1, participa...
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 one or more conventional and/or biologic therapies (oral locally acting steroids, intravenous or oral corticosteroids, immunosuppressants or biologic therapies for CD), 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
- 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, \> 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum, 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.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2022
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT03345849
Start Date
December 7 2017
End Date
January 13 2022
Last Update
November 23 2022
Active Locations (432)
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1
East View Medical Research, LLC /ID# 171176
Mobile, Alabama, United States, 36606
2
CB Flock Research Corporation /ID# 166185
Mobile, Alabama, United States, 36608
3
Delsol Research Management, Ll /Id# 170145
Chandler, Arizona, United States, 85224
4
HonorHealth Research Institute - Shea /ID# 164821
Scottsdale, Arizona, United States, 85258