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
  • Ulcerative Colitis (UC)
  • Study Drug
  • Placebo
  • Upadacitinib
  • 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
    Showing {first} - {last} of {total} Results