At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 522 enrolled
Drug / intervention
Placebo +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 to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Placebo and Upadacitinib for Ulcerative Colitis (UC). Completed, enrolled 522 participants across 379 sites in 44 countries.
Detailed Summary
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis (UC)
CountriesArgentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartDec 2018
Primary CompletionJan 2021
TodayJul 2026
First PostedAug 31, 2018
Enrollment StartDec 6, 2018
Primary CompletionJan 14, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.8 years ago
Interventions
Placebodrug
Tablet for oral administration
Upadacitinibdrug
Tablet for oral administration