NCT04195698

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Upadacitinib	Upadacitinib will be administered oral as tablet

Timeline

• Start date: 2020-01-15
• Primary completion: 2023-09-11
• Completion: 2023-09-11
• First posted: 2019-12-12
• Last updated: 2025-01-09
• Results posted: 2025-01-09

Locations

116 sites across 22 countries: United States, Australia, Canada, Croatia, Czechia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study