Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

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 achieve clinical response in Study M14-431 or Study M14-433.
  • Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.

For Substudy 2:

  • Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
  • Participant who achieved clincal response at the time descibed in the protocol and completes study procedures in the parent study/ substudy.

For Substudy 3:

  • Participant is an ongoing participant in Substudy 2 for at least 12 months.
  • Participant is in stable remission for at least 6 months defined as:
    1. CDAI < 150
    2. CRP < 5 mg/L and FCP < 250 mg/kg AND
    3. Participant has not been on locally acting (rectal or suppository) or systemic corticosteroids for CD => 90 days prior to the entry of Substudy 3.

You CAN'T join if...

For Substudies 1,2 and 3:

  • 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 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
  • Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
  • Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 or 2 of Study M14-430 (Week 52).

For Substudy 3 only:

  • Total SES-CD >4 and/or subscore >1 in any segment in the Substudy 2 annual ileo-colonoscopy, if performed within 6 months prior to Week 0 of Substudy 3.
  • Received any new medication or increase of the dose of current concomitant medication for the treatment of CD in the past 3 months.

Locations

  • UCSF Center for Colitis and Crohn's Disease /ID# 202372
    San Francisco California 94115-3011 United States
  • Univ of California San Francis /ID# 164653
    San Francisco California 94158 United States
  • Care Access Research /ID# 167765
    San Pablo California 94806 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related info
ID
NCT03345823
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 747 study participants
Last Updated