NCT05651711已完成3 期
A Phase 3, Randomized, 24-week, 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) (ROCKET-Horizon)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 726
- 试验地点
- 359
- 主要终点
- Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a ≥ 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
研究概览
简要总结
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).
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 (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) 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 or higher potency (with or without topical calcineurin inhibitors [TCI]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
- •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
- •Oral or topical 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 (PDE4) inhibitors
- •Other topical immunosuppressive agents
- •Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents
研究组 & 干预措施
Rocatinlimab
Experimental
Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
干预措施: Rocatinlimab (Drug)
Placebo
Placebo Comparator
Placebo Q4W for 24 weeks with a loading dose at Week 2.
干预措施: Placebo (Other)
结局指标
主要结局
Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a ≥ 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
时间窗: Baseline and Week 24
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
时间窗: Baseline and 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
- Achievement of 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)
- Achievement of 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)
- Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline(Baseline and Week 24)
- Achievement of vIGA-AD 0/1 at Week 16(Baseline and Week 16)
- Achievement of a ≥ 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 Weekly Average of Daily AD Skin Pain NRS Score at Week 24(Baseline to Week 24)
- Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24(Baseline and Week 24)
- Achievement of ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4(Baseline to Week 24)
- Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline(Baseline and Week 24)
- Achievement of a ≥ 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)
- Change from Baseline in POEM 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)
- Achievement of ≥ 3-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 3(Baseline to Week 24)
- Achievement of ≥ 3-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 3(Baseline to Week 16)
- Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24(Baseline to Week 24)
- Achievement of EASI 75 at Week 16(Baseline and Week 16)
- Achievement of ≥ 4-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4(Baseline to Week 16)
- Achievement of 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)
- Achievement of a ≥ 8.7-point Reduction From Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7(Baseline and Week 24)
- Achievement of 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)
- Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16(Baseline and Week 16)
- Achievement of 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 DLQI Score at Week 24(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 SCORAD Itch VAS 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 EASI 75 at Week 16(Baseline and Week 16)
- Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of 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) (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 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 Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16(Baseline and Week 16)
- 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 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)
- 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
研究点 (359)
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