BENITIONSClinical Trial Intelligence

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
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
完成日期2024年11月28日
结果公布日2026年7月23日

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

Placebo18 Participants
Rocatinlimab 150 mg Q4W35 Participants
Rocatinlimab 300 mg Q4W74 Participants
p-value= 0.010
Common risk difference percentage8.0 (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

Placebo28 Participants
Rocatinlimab 150 mg Q4W78 Participants
Rocatinlimab 300 mg Q4W138 Participants
p-value< 0.001
Common risk difference percentage23.4 (95% CI 15.4–30.9)

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。