Summary

for people ages 18-99 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

Official Title

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis

Keywords

Ulcerative Colitis (UC) Upadacitinib (ABT-494) Open-Label Extension (OLE) Safety Efficacy Colitis Ulcer Colitis, Ulcerative

Eligibility

You can join if…

Open to people ages 18-99

  • Participant has not achieved clinical response at the end of the induction period(Week 8) in Study M14-234 Substudy 1, has had loss of response during the maintenance period of Study M14-234 Substudy 3, or has successfully completed Study M14-234 Substudy 3.
  • If female, participant must meet the criteria for Contraception Recommendations.
  • Women of childbearing potential must have a negative urine pregnancy test at Week 0 visit.
  • Participant is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study(Study M14-234).
  • Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.

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 the final visit of Study M14-234 or who is considering becoming pregnant during the study or within 30 days after the last dose of study drug.
  • Participant with an active or recurrent infection that based on the investigator's clinical assessment makes the participant an unsuitable candidate for the study.Participants with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
  • Current evidence of active or untreated latent tuberculosis.
  • Participant with a poorly controlled medical condition, such as uncontrolled diabetes,unstable ischemic heart disease, moderate or severe congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.
  • Participants have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of Study M14-234.
  • History of any malignancy except for successfully treated nonmelanoma skin cancer(NMSC) or localized carcinoma in situ of the cervix from evaluations performed in Study M14-234.

Locations

  • UC San Diego Health System /ID# 155187
    La Jolla California 92093 United States
  • Medical Assoc Research Grp /ID# 169149
    San Diego California 92123 United States
  • United Gastroenterologists /ID# 151213
    Murrieta California 92563 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03006068
Phase
Phase 3
Study Type
Interventional
Last Updated
July 27, 2018