A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
3期
已完成
NCT05398445
| 适应症 | Atopic Dermatitis |
|---|
| 分期 | 3期 |
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| 申办方 | Amgen |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 769 人 |
|---|
| 干预(药物) | Rocatinlimab |
|---|
| 开始日期 | 2022年5月31日 |
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| 完成日期 | 2024年11月28日 |
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| 结果公布日 | 2026年7月23日 |
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摘要
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
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 | 18 Participants |
|---|
| Rocatinlimab 150 mg Q4W | 35 Participants |
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| Rocatinlimab 300 mg Q4W | 74 Participants |
|---|
| p-value | = 0.010 |
| Common risk difference percentage | 8.0 (95% CI 1.8–14.0) |
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 | 28 Participants |
|---|
| Rocatinlimab 150 mg Q4W | 78 Participants |
|---|
| Rocatinlimab 300 mg Q4W | 138 Participants |
|---|
| p-value | < 0.001 |
| Common risk difference percentage | 23.4 (95% CI 15.4–30.9) |
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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。