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
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ClinicalTrials.gov Identifier: NCT03345836 |
Recruitment Status :
Recruiting
First Posted : November 17, 2017
Last Update Posted : February 26, 2021
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | November 15, 2017 | ||||||||||||||||
First Posted Date ICMJE | November 17, 2017 | ||||||||||||||||
Last Update Posted Date | February 26, 2021 | ||||||||||||||||
Actual Study Start Date ICMJE | November 29, 2017 | ||||||||||||||||
Estimated Primary Completion Date | June 17, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | 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 | ||||||||||||||||
Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy | ||||||||||||||||
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). | ||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Crohn's Disease | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
645 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
855 | ||||||||||||||||
Estimated Study Completion Date ICMJE | October 7, 2021 | ||||||||||||||||
Estimated Primary Completion Date | June 17, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States | ||||||||||||||||
Removed Location Countries | American Samoa, Belarus | ||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT03345836 | ||||||||||||||||
Other Study ID Numbers ICMJE | M14-431 2017-001226-18 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | AbbVie | ||||||||||||||||
Study Sponsor ICMJE | AbbVie | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE |
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PRS Account | AbbVie | ||||||||||||||||
Verification Date | February 2021 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |