A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)
第3相
完了
NCT03607422
| 対象疾患 | Atopic Dermatitis |
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| 相 | 第3相 |
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| スポンサー | AbbVie |
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| ステータス | 完了 |
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| 参加者数 | 912 名 |
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| 介入（薬剤） | Placebo for Upadacitinib, Upadacitinib |
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| 開始日 | 2018年7月27日 |
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| 完了日 | 2021年3月11日 |
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| 結果公開日 | 2022年3月28日 |
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概要
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 | 13.3 percentage of participants |
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| Upadacitinib 15 mg QD | 60.1 percentage of participants |
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| Upadacitinib 30 mg QD | 72.9 percentage of participants |
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| p-value | <0.001 |
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| Adjusted Response Rate Difference | 59.6 (95% CI 53.1–66.2) |
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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 | 4.7 percentage of participants |
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| Upadacitinib 15 mg QD | 38.8 percentage of participants |
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| Upadacitinib 30 mg QD | 52.0 percentage of participants |
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| p-value | <0.001 |
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| Adjusted Response Rate Difference | 47.4 (95% CI 41.0–53.7) |
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