BENITIONSClinical Trial Intelligence

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
申办方Amgen
状态已完成
受试者人数726 人
干预(药物)Rocatinlimab
开始日期2022年12月14日
完成日期2024年6月5日
结果公布日2026年6月26日

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

Placebo9 Participants
Rocatinlimab 300 mg Q4W89 Participants
p-value< 0.001
Common risk difference percentage11.5 (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

Placebo25 Participants
Rocatinlimab 300 mg Q4W178 Participants
p-value< 0.001
Common risk difference percentage19.1 (95% CI 12.4–25.2)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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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。