A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)
Фаза 3
Завершено
NCT03607422
| Заболевание | Atopic Dermatitis |
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| Фаза | Фаза 3 |
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| Спонсор | AbbVie |
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| Статус | Завершено |
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| Участники | 912 участн. |
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| Вмешательство | Placebo for Upadacitinib, Upadacitinib |
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| Дата начала | 27.07.2018 |
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| Дата завершения | 11.03.2021 |
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| Публикация результатов | 28.03.2022 |
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Кратко
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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