A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

• Status: Active, not recruiting
• Trial end date: 2025-09-17
• Target enrollment: 0
• Participant gender: All

Summary

This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Upadacitinib

Criteria

Inclusion Criteria:

• Participant must have completed Study M13-740 through Week 52.

• If female, participant must be postmenopausal, surgically sterile or on using a birth control method.

Exclusion Criteria:

• For any reason participant is considered by the investigator to be an unsuitable candidate

• Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.

• Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.