At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib for the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046
In Brief
A Phase 3 clinical trial evaluating Upadacitinib for Atopic Dermatitis. Completed, enrolled 475 participants across 116 sites in 22 countries.
Detailed 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.
Study Details
Timeline
Interventions
Upadacitinib will be administered oral as tablet