临床试验/NCT05398445

NCT05398445已完成3 期

A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)

Amgen384 个研究点分布在 2 个国家目标入组 769 人开始时间: 2022年5月31日最近更新: 2026年7月23日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Amgen
入组人数: 769
试验地点: 384
主要终点: Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 100 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
•History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors [TCI]).
•EASI score ≥16
•vIGA-AD score ≥3
•≥10% body surface area (BSA) of AD involvement
•Worst pruritus numerical rating scale ≥ 4

排除标准

•Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
•Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
•Systemic corticosteroids
•Systemic immunosuppressants
•Phototherapy
•Janus kinase inhibitors
•Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
•TCS of any potency
•Topical phosphodiesterase type 4 inhibitors
•Other topical immunosuppressive agents
•Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents

研究组 & 干预措施

Arm B

Experimental

Rocatinlimab Dose 2 Q4W + loading dose at Week 2

干预措施: Rocatinlimab (Drug)

Arm A

Experimental

Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2

干预措施: Rocatinlimab (Drug)

Arm C

Placebo Comparator

Placebo Q4W+ loading dose at Week 2

干预措施: Placebo (Drug)

结局指标

主要结局

Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24

时间窗: Baseline, Week 24

Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24

时间窗: Baseline, Week 24

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

时间窗: Baseline and Week 24

vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," the participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, the participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24

时间窗: Baseline and Week 24

EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

次要结局

Change from baseline in HADS-depression subscale score at Week 24(Baseline, Week 24)
Achievement of ≥75% reduction from baseline in EASI score at Week 16(Baseline, Week 16)
Achievement of a vIGA-AD score of 0 or 1 from baseline at Week 16(Baseline, Week 16)
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus numerical rating scale (NRS) score at Week 16 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4(Baseline, Week 16)
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus NRS score at Week 24 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4(Baseline, Week 24)
Achievement of ≥90% reduction from baseline in EASI score at Week 24(Baseline, Week 24)
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 24 in subjects with baseline weekly average of AD skin pain NRS score ≥ 4(Baseline, Week 24)
Achievement of a 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, Week 24)
Achievement of Facial AD Severity Score (FASS) of clear at Week 24 for subjects with facial AD at baseline(Baseline, Week 24)
Change from baseline in weekly average of daily worst pruritus NRS score at week 16(Baseline, Week 16)
Change from baseline in weekly average of daily worst pruritus NRS score at Week 24(Baseline, Week 24)
Achievement of Hand AD Severity Score (HASS) of clear at Week 24 for subjects with hand AD at baseline(Baseline, Week 24)
Change from baseline in SCORing Atopic Dermatitis (SCORAD) itch visual analogue scale (VAS) score at Week 16(Baseline, Week 16)
Change from baseline in SCORAD itch VAS score at Week 24(Baseline, Week 24)
Achievement of ≥ 4-point reduction from baseline in DLQI score at Week 24 in subjects with baseline DLQI score ≥ 4(Baseline, Week 24)
Change from baseline in DLQI score at Week 24(Baseline, Week 24)
Achievement of ≥ 4-point reduction from baseline in POEM score at Week 24 in subjects with baseline POEM score ≥ 4(Baseline, Week 24)
Change from baseline in POEM score at Week 24(Baseline, Week 24)
Change from baseline in HADS-anxiety subscale score at Week 24(Baseline, Week 24)
Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score ≥ 8(Baseline, Week 24)
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 16 in subjects with baseline weekly average of AD skin pain NRS score ≥ 4(Baseline, Week 16)
Change from baseline in weekly average of daily AD skin pain NRS score at Week 24(Baseline, Week 24)
Change from baseline in weekly average of daily AD skin pain NRS score at Week 16(Baseline, Week 16)
Achievement of a ≥ 3-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 24 in subjects with baseline weekly average of AD skin pain NRS score ≥ 3(Baseline, Week 24)
Achievement of a ≥ 3-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 16 in subjects with baseline weekly average of AD skin pain NRS score ≥ 3(Baseline, Week 16)
Change from baseline in weekly average of daily sleep disturbance NRS score at Week 24(Baseline, Week 24)
Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety subscale score < 8 at Week 24 in subjects with baseline HADS-anxiety subscale score ≥ 8(Baseline, Week 24)
Achievement of a ≥ 8.7-point reduction from baseline in SCORAD score at Week 24 in participants with baseline SCORAD score ≥ 8.7(Baseline, Week 24)
Change From Baseline in DLQI Score at Week 24(Baseline and Week 24)
Number of Participants Who Achieved EASI 75 at Week 16(Baseline and Week 16)
Number of Participants Who Achieved vIGA-AD 0/1 at Week 16(Baseline and Week 16)
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4(Baseline and Week 16)
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4(Baseline and Week 24)
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24(Baseline and Week 24)
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4(Baseline and Week 24)
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) With a ≥ 2-Point Reduction From Baseline (vIGA-AD 0/1) at Week 24(Baseline and Week 24)
Number of Participants Who Achieved Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline(Baseline and Week 24)
Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline(Baseline and Week 24)
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16(Baseline and Week 16)
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24(Baseline and Week 24)
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16(Baseline and Week 16)
Change From Baseline in SCORAD Itch VAS Score at Week 24(Baseline and Week 24)
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4(Baseline and Week 24)
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4(Baseline and Week 24)
Change From Baseline in POEM Score at Week 24(Baseline and Week 24)
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4(Baseline and Week 16)
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24(Baseline and Week 24)
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16(Baseline and Week 16)
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3(Baseline and Week 24)
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3(Baseline and Week 16)
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24(Baseline and Week 24)
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8(Baseline and Week 24)
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8(Baseline and Week 24)
Change From Baseline in HADS-anxiety Subscale Score at Week 24(Baseline and Week 24)
Change From Baseline in HADS-depression Subscale Score at Week 24(Baseline and Week 24)
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7(Baseline and Week 24)

研究者

发起方

Amgen

申办方类型

Industry

责任方

Sponsor

研究点 (384)

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