This study is in progress, not accepting new patients

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

a study on Crohn's Disease Inflammatory Bowel Disease

Summary

for people ages 18-75 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease

Keywords

Crohn's Disease (CD) Crohn's Disease Efficacy Safety Tolerability ABT-494 Crohn Disease Upadacitinib (ABT-494) Dose A Upadacitinib (ABT-494) Dose B

Eligibility

You can join if…

Open to people ages 18-75

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Ucsd /Id# 150041
    La Jolla California 92037 United States
  • Univ California, San Francisco /ID# 149987
    San Francisco California 94143-2204 United States
  • Aspen Clinical Research /ID# 150020
    Orem Utah 84058 United States
  • University of Washington /ID# 149988
    Seattle Washington 98109 United States
  • Texas Digestive Disease Consul /ID# 149869
    Southlake Texas 76092 United States
  • Texas Digestive Disease Consul /ID# 149989
    Southlake Texas 76092 United States
  • Univ British Columbia /ID# 149876
    Vancouver British Columbia V5Z 4E8 Canada
  • GIRI Gastrointestinal Research Institute /ID# 149878
    Vancouver British Columbia V6Z 2K5 Canada
  • Options Health Research, LLC /ID# 150010
    Tulsa Oklahoma 74104 United States
  • Cotton-O'Neil Clinical Res Ctr /ID# 149900
    Topeka Kansas 66606 United States
  • Kansas City Research Institute /ID# 149888
    Kansas City Missouri 64131 United States
  • Zeidler Ledcor Centre /ID# 149873
    Edmonton Alberta T6G 2X8 Canada

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02782663
Phase
Phase 2
Study Type
Interventional
Last Updated
June 4, 2018