A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Study Identifier
M14-234
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, Dutch, Italian, Japanese, Russian, Turkish
Scientific Result Summary
Available Language(s): English
Study Details
Medical Condition
Study Drug
Phase
Phase 2/Phase 3
Sex
Female & Male
Age
16 - 75 Years
Protocol Summary
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.
Study Locations
Location
Status
Location
Birmingham Gastroenterology Associates P.C /ID# 151276
Birmingham, Alabama, United States, 35209
Status
Not applicable
Location
East View Medical Research, LLC /ID# 171183
Mobile, Alabama, United States, 36606
Status
Not applicable
Location
CB Flock Research Corporation /ID# 165980
Mobile, Alabama, United States, 36608
Status
Not applicable
Location
Delsol Research Management, Ll /Id# 170131
Chandler, Arizona, United States, 85224
Status
Not applicable
Location
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885
Mesa, Arizona, United States, 85206
Status
Not applicable
Location
Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822
Sun City, Arizona, United States, 85306
Status
Not applicable
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