This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the M16-046 study. 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
- Conditions
- Moderate to severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2019-001227-12-GB
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
• Subjects should have successfully completed treatment in the M16-046 study, without developing any permanent discontinuation criteria.
• Subject 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 M16-046 study to continue treatment in the long term extension study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 570
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
• Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions
• Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess long-term safety, tolerability and efficacy of upadacitinib in adult subjects with moderate to severe atopic dermatitis who successfully completed treatment in the M16-046 study;Secondary Objective: None;Primary end point(s): Treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) of special interest (AESI), AEs leading to discontinuation of study drug; vital signs, laboratory tests, and physical examination findings.;Timepoint(s) of evaluation of this end point: At each visit
- Secondary Outcome Measures
Name Time Method