Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
3期
已完成
NCT03569293
| 适应症 | Atopic Dermatitis |
|---|
| 分期 | 3期 |
|---|
| 申办方 | AbbVie |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 912 人 |
|---|
| 干预（药物） | Placebo for Upadacitinib, Upadacitinib |
|---|
| 开始日期 | 2018年8月13日 |
|---|
| 完成日期 | 2021年1月6日 |
|---|
| 结果公布日 | 2022年2月3日 |
|---|
摘要
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) |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
同一适应症的其他试验
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。