Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

• Status: Active, not recruiting
• Trial end date: 2023-03-02
• Target enrollment: 0
• Participant gender: All

Summary

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Upadacitinib

Criteria

Inclusion Criteria:

• Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria.

• Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.

Exclusion Criteria:

• Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.

• Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.