Moderate to Severe Atopic Dermatitis MedDRA version: 20.0 Level: PT Classification code 10012438 Term: Dermatitis atopic System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Upadacitinib
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Conce
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female subjects = 18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Prior exposure to any JAK inhibitor • Unable or unwilling to discontinue current AD treatments prior to the study • Requirement of prohibited medications during the study treatment • Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objectives are: 1) To generate descriptive data on the efficacy and safety of dose escalation to upadacitinib 30 mg QD and dose reduction to upadacitinib 15 mg QD based on a clinical response after 12 weeks of treatment. This data will inform the clinical management for subjects with moderate to severe AD treated with both approved doses of upadacitinib. 2) To generate evidence on the subject impact of upadacitinib treatment decision-making based on targeting at least a 90% reduction in Eczema Area and Severity Index (EASI 90) skin clearance (Treat to Target).;Secondary Objective: N/A;Primary end point(s): The primary endpoints are: 1. Achievement of EASI 75 at Week 24. 2. Achievement of EASI 90 at Week 24. 3. Achievement of EASI 90 and Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 24.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: 1. Achievement of EASI 75 / 90 /100 at Week 12. 2. Achievement of EASI 100 at Week 24. 3. Achievement of EASI 90 and Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12. 4. Achievement of validated Investigator´s Global Assessment for AD (vIGA-AD) of 0 or 1 at Week 12. 5. Achievement of vIGA-AD of 0 or 1 at Week 24. 6. Achievement of an improvement (reduction) in Worst Pruritus (NRS = 4 for subjects with Worst Pruritus NRS = 4 at Baseline at Week 12. 7. Achievement of an improvement (reduction) in Worst Pruritus NRS = 4 for subjects with Worst Pruritus NRS = 4 at Baseline at Week 24. 8. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12.' 9. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 24. 10. Achievement of an improvement (reduction) from Baseline in Dermatology Life Quality Index (DLQI) = 4 for subjects with DLQI = 4 at Baseline at Week 12. 11. Achievement of an improvement (reduction) from Baseline in DLQI = 4 for subjects with DLQI = 4 at Baseline at Week 24. 12. Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 12. 13. Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 24.;Timepoint(s) of evaluation of this end point: Week 12/24 | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Slovakia, Spain, Taiwan, United Kingdom
Contacts
Public ContactGlobal Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed