A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT03345823

Run by

AbbVie

People needed

747

Starts

2018-03-21

Expected to finish

2027-09-01

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.

You may not qualify if…

• For Substudies 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 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 of Study M14-430 (Week 52).

Where it is running

• CB Flock Research Corporation /ID# 166239 — Mobile, Alabama, United States
• Delsol Research Management, Ll /Id# 170164 — Chandler, Arizona, United States
• Duplicate_HonorHealth Research Institute - Shea /ID# 164725 — Scottsdale, Arizona, United States
• Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702 — Sun City, Arizona, United States
• Southern California Res. Ctr. /ID# 169653 — Coronado, California, United States
• Citrus Valley Gastroenterology /ID# 166230 — Covina, California, United States
• Hoag Memorial Hosp Presbyterian /ID# 222538 — Irvine, California, United States
• UC San Diego Health System /ID# 164763 — La Jolla, California, United States
• United Medical Doctors /ID# 207458 — Los Alamitos, California, United States
• Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164640 — Los Angeles, California, United States
• Facey Medical Foundation /ID# 203138 — Mission Hills, California, United States
• United Medical Doctors - Murrieta /ID# 164602 — Murrieta, California, United States
• Medical Assoc Research Grp /ID# 169704 — San Diego, California, United States
• UCSF Medical Center - Mount Zion /ID# 202372 — San Francisco, California, United States
• Univ of California San Francis /ID# 164653 — San Francisco, California, United States
• Care Access Research /ID# 167765 — San Pablo, California, United States
• Peak Gastroenterology Associates, PC /ID# 170166 — Colorado Springs, Colorado, United States
• Delta Waves, Inc. /ID# 164656 — Colorado Springs, Colorado, United States
• Western States Clinical Res /ID# 164625 — Wheat Ridge, Colorado, United States
• Gastroenterology Center of Connecticut /ID# 164614 — Hamden, Connecticut, United States
• Advanced Research - Coral Springs /ID# 218019 — Coral Springs, Florida, United States
• Encore Borland-Groover Clinical Research /Id# 203500 — Jacksonville, Florida, United States
• Ctr for Advanced Gastroenterol /ID# 165306 — Maitland, Florida, United States
• Crystal Pharmacology Research /ID# 166118 — Miami, Florida, United States
• East View Medical Research, LLC /ID# 171132 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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