At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 624 enrolled
Drug / intervention
Matching Placebo for 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 Biologic Therapy
In Brief
A Phase 3 clinical trial evaluating Matching Placebo for Upadacitinib and Upadacitinib for Crohn's Disease. Completed, enrolled 624 participants across 428 sites in 48 countries.
Detailed 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).
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), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartNov 2017
Primary CompletionAug 2021
TodayJul 2026
First PostedNov 17, 2017
Enrollment StartNov 29, 2017
Primary CompletionAug 11, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.6 years ago
Interventions
Matching Placebo for Upadacitinibdrug
Matching placebo tablets
Upadacitinibdrug
Upadacitinib tablets