A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
3期
已完成
NCT05651711
| 适应症 | Atopic Dermatitis |
|---|
| 分期 | 3期 |
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| 申办方 | Amgen |
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| 状态 | 已完成 |
|---|
| 受试者人数 | 726 人 |
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| 干预(药物) | Rocatinlimab |
|---|
| 开始日期 | 2022年12月14日 |
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| 完成日期 | 2024年6月5日 |
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| 结果公布日 | 2026年6月26日 |
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摘要
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 |
|---|
| Rocatinlimab 300 mg Q4W | 89 Participants |
|---|
| 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 |
|---|
| Rocatinlimab 300 mg Q4W | 178 Participants |
|---|
| p-value | < 0.001 |
| Common risk difference percentage | 19.1 (95% CI 12.4–25.2) |
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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。