NCT03345823

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 747 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Upadacitinib	Oral; Tablet
DRUG	Placebo for Upadacitinib	Oral; Tablet

Timeline

• Start date: 2018-03-21
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2017-11-17
• Last updated: 2026-04-09

Locations

466 sites across 49 countries: United States, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study