A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

Study Identifier
M14-327
CT.gov Identifier
NCT02782663
EudraCT Identifier
2015-003759-23
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
  • ABT-494
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant must have completed Study M13-740 through Week 52. * If female, participant must be postmenopausal, surgically sterile or on using a birth control method.
    Exclusion Criteria:
    * For any reason participant is considered by the investigator to be an unsuitable candidate * Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study. * Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

    Protocol Summary

    This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

    Study Locations

    Location
    Status
    Location
    UC San Diego Health System /ID# 150041
    La Jolla, California, United States, 92037
    Status
    Not applicable
    Location
    Univ California, San Francisco /ID# 149987
    San Francisco, California, United States, 94143-2204
    Status
    Not applicable
    Location
    Duplicate_University of Florida - Archer /ID# 150033
    Gainesville, Florida, United States, 32610
    Status
    Not applicable
    Location
    The Ctr for Gastro Disorders /ID# 150012
    Hollywood, Florida, United States, 33021
    Status
    Not applicable
    Location
    Nature Coast Clinical Research - Inverness /ID# 149975
    Inverness, Florida, United States, 34452-4717
    Status
    Not applicable
    Location
    Gastroenterology Associates of Central Georgia, LLC /ID# 149870
    Macon, Georgia, United States, 31201
    Status
    Not applicable
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