BENITIONSClinical Trial Intelligence

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

第3相 完了 NCT05651711

対象疾患Atopic Dermatitis
第3相
スポンサーAmgen
ステータス完了
参加者数726 名
介入(薬剤)Rocatinlimab
開始日2022年12月14日
完了日2024年6月5日
結果公開日2026年6月26日

概要

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)

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