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Summary

for people ages 18–75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Keywords

Crohn's Disease Upadacitinib ABT-494 Extension Study Efficacy Safety Maintenance Study Crohn Disease

Eligibility

You can join if…

Open to people ages 18–75

For Substudy 1:

  • Participant who receive double-blind treatment in Study M14-431 or Study M14-433 and achieve clinical response.
  • Participant completes study procedures in the parent study.

For Substudy 2:

  • Participant completes Substudy 1
  • Participant who receive open-label upadacitinib Dose B in Study M14-431 and achieve clinical response.
  • Participant completes study procedures in the parent study/substudy.

You CAN'T join if...

For Sub-studies 1 and 2:

  • Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 of Study M14-430 that in the investigator's judgment makes the subject unsuitable for this study.
  • Participant with any active or chronic recurring infections based on the investigator's assessment that makes the subject an unsuitable candidate for the study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is cured,based on the investigator's assessment.
  • Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Study M14-431 (Week 24) or Substudy 1 of Study M14-430 (Week 52).

Locations

  • UCSF Center for Colitis and Crohn's Disease
    San Francisco, California, 94115-3011, United States
  • Univ of California San Francis
    San Francisco, California, 94158, United States
  • Gastrointestinal Biosciences
    Los Angeles, California, 90067-2001, United States
  • Citrus Valley Gastroenterology
    Covina, California, 91722-3797, United States
  • United Gastroenterologists
    Murrieta, California, 92563, United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03345823
Phase
Phase 3
Study Type
Interventional
Last Updated
March 29, 2018