A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Фаза 3
Завершено
NCT05651711
| Заболевание | Atopic Dermatitis |
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| Фаза | Фаза 3 |
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| Спонсор | Amgen |
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| Статус | Завершено |
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| Участники | 726 участн. |
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| Вмешательство | Rocatinlimab |
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| Дата начала | 14.12.2022 |
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| Дата завершения | 5.06.2024 |
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| Публикация результатов | 26.06.2026 |
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Кратко
The co-primary objectives of the study are to: * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).
Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (vIGA-AD) 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
Baseline and Week 24 · Participants
| Placebo | 9 Participants |
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| Rocatinlimab 300 mg Q4W | 89 Participants |
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| p-value | < 0.001 |
| Common risk difference percentage | 11.5 (95% CI 6.7–15.5) |
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Baseline and Week 24 · Participants
| Placebo | 25 Participants |
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| Rocatinlimab 300 mg Q4W | 178 Participants |
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| p-value | < 0.001 |
| Common risk difference percentage | 19.1 (95% CI 12.4–25.2) |
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