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
Phase 3
Completed
- Conditions
- Atopic DermatitisEczema1000381610014982
- Registration Number
- NL-OMON55265
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
• 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.
Exclusion Criteria
• 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Treatment emergent adverse events (TEAEs), serious adverse events (SAEs),<br /><br>adverse events (AEs) of special interest (AESI), AEs leading to discontinuation<br /><br>of study drug; vital signs, laboratory tests, and physical examination<br /><br>findings.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Change and percent change from Baseline in worst pruritus numerical rating<br /><br>scale (NRS)<br /><br>- Change and percent change from Baseline in EASI<br /><br>- Proportion of subjects achieving EASI 75/90/100<br /><br>- Evaluation of known and/or novel disease-related or drug-related biomarkers </p><br>