Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
Phase 3
Completed
NCT03569293
| Condition | Atopic Dermatitis |
|---|
| Phase | Phase 3 |
|---|
| Sponsor | AbbVie |
|---|
| Status | Completed |
|---|
| Enrollment | 912 participants |
|---|
| Interventions | Placebo for Upadacitinib, Upadacitinib |
|---|
| Start date | Aug 13, 2018 |
|---|
| Completion date | Jan 6, 2021 |
|---|
| Results posted | Feb 3, 2022 |
|---|
Summary
The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
Baseline and Week 16 · percentage of participants
| Placebo | 16.3 percentage of participants |
|---|
| Upadacitinib 15 mg QD | 69.6 percentage of participants |
|---|
| Upadacitinib 30 mg QD | 79.7 percentage of participants |
|---|
| p-value | <0.001 |
| Adjusted Response Rate Difference | 63.4 (95% CI 57.1–69.8) |
Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16
Baseline and Week 16 · percentage of participants
| Placebo | 8.4 percentage of participants |
|---|
| Upadacitinib 15 mg QD | 48.1 percentage of participants |
|---|
| Upadacitinib 30 mg QD | 62.0 percentage of participants |
|---|
| p-value | <0.001 |
| Adjusted Response Rate Difference | 53.6 (95% CI 47.2–60.0) |
Open in BENITIONS
View on ClinicalTrials.gov
Other trials for this condition
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.