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 |
|---|
| 相 | 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
| 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) |
BENITIONS で見る
ClinicalTrials.gov の原文を見る
同じ疾患の他の治験
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。