At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 526 enrolled
Drug / intervention
Upadacitinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Conventional and/or Biologic Therapies
In Brief
A Phase 3 clinical trial evaluating Upadacitinib and Placebo for Upadacitinib for Crohn's Disease. Completed, enrolled 526 participants across 432 sites in 49 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesArgentina, 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, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartDec 2017
Primary CompletionOct 2021
Study CompletionJan 2022
TodayJul 2026
First PostedNov 17, 2017
Enrollment StartDec 7, 2017
Primary CompletionOct 15, 2021
Study CompletionJan 13, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.6 years ago
Interventions
Upadacitinibdrug
Oral; Tablet
Placebo for Upadacitinibdrug
Oral; Tablet