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一项评估 Rocatinlimab 治疗中度至重度特应性皮炎的研究 (ROCKET-IGNITE) (ROCKET-Ignite)

2026年6月25日 更新者：Amgen

一项为期 24 周的随机、安慰剂对照、双盲研究，旨在评估 Rocatinlimab (AMG 451) 单药治疗中度至重度特应性皮炎 (AD) 成年受试者的疗效、安全性和耐受性

本研究的目的是评估 rocatinlimab 在单药治疗中的有效性和安全性。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

769

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100044
        • Peking University Peoples Hospital
      • Shanghai、中国、200443
        • Shanghai Skin Disease Hospital
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100191
        • Peking University Third Hospital
      • Beijing、Beijing Municipality、中国、100050
        • Beijing Friendship hospital, Capital Medical University
    • Fujian
      • Fuzhou、Fujian、中国、350000
        • The First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou、Guangdong、中国、510091
        • Dermatology Hospital of Southern Medical University
      • Guangzhou、Guangdong、中国、510120
        • Sun Yat-sen Memorial Hospital Sun Yat-sen university
      • Guangzhou、Guangdong、中国、510080
        • The First Affiliated Hospital ,Sun-Yat Sen University
    • Hebei
      • Shijiazhuang、Hebei、中国、050000
        • The First Hospital of Hebei Medical University
    • Henan
      • Nanyang、Henan、中国、473002
        • Nanyang First Peoples Hospital
      • Sanmenxia、Henan、中国、472099
        • Sanmenxia Central Hospital
    • Hubei
      • Wuhan、Hubei、中国、430022
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
    • Hunan
      • Changsha、Hunan、中国、410011
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Jiangyin、Jiangsu、中国、214400
        • Jiangyin Hospital of Traditional Chinese Medicine
      • Wuxi、Jiangsu、中国、241023
        • Wuxi Peoples Hospital
    • Jiangxi
      • Nanchang、Jiangxi、中国、330000
        • Dermatology Hospital of Jiangxi Province
    • Jilin
      • Changchun、Jilin、中国、130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang、Liaoning、中国、110001
        • The First Hospital of China Medical University
    • Sichuan
      • Chengdu、Sichuan、中国、610021
        • Chengdu Second Peoples Hospital
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310003
        • The First Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou、Zhejiang、中国、310020
        • Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
      • Hangzhou、Zhejiang、中国、310004
        • Zhejiang Provincial Peoples Hospital
      • Taizhou、Zhejiang、中国、318000
        • Taizhou Central Hospital
  • 克罗地亚
      • Ivanić-Grad、克罗地亚、10310
        • Special Hospital for Medical Rehabilitation Naftalan
      • Zagreb、克罗地亚、10000
        • University Hospital Centre Zagreb
      • Zagreb、克罗地亚、10000
        • Sestre milosrdnice University Hospital Center
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 1C3
        • Alberta Derma Surgery Centre
      • Edmonton、Alberta、加拿大、T6H 4J8
        • Vida Clinical Research
    • Ontario
      • Ajax、Ontario、加拿大、L1S 7K8
        • CCA Medical Research Corporation
      • Barrie、Ontario、加拿大、L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre
      • Hamilton、Ontario、加拿大、L8L 3C3
        • LEADER research
      • Mississauga、Ontario、加拿大、L4Y 4C5
        • DermEdge Research Incorporated
      • North York、Ontario、加拿大、M3B 3S6
        • Gordon Sussman Clinical Research Incorporated
      • North York、Ontario、加拿大、M3B 0A7
        • Canadian Dermatology Centre
      • Richmond Hill、Ontario、加拿大、L4E 4L6
        • Oak Ridges Aesthetics Centre
    • Quebec
      • Montreal、Quebec、加拿大、H2X 2V1
        • Innovaderm Research Inc
      • Québec、Quebec、加拿大、G1G 3Y8
        • Recherche Clinique Sigma Incorporated
    • Saskatchewan
      • Saskatoon、Saskatchewan、加拿大、S7K 2C1
        • Skinsense Medical Research
  • 匈牙利
      • Veszprém、匈牙利、8200
        • MedMare Bt
  • 台湾
      • Kaohsiung City、台湾、83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Tainan、台湾、70403
        • National Cheng Kung University Hospital
      • Taipei、台湾、10002
        • National Taiwan University Hospital
      • Taipei、台湾、11217
        • Taipei Veterans General Hospital
      • Taipei、台湾、10449
        • MacKay Memorial Hospital Taipei Branch
      • Taoyuan、台湾、33305
        • Linkou Chang Gung Memorial Hospital
  • 巴西
      • Rio de Janeiro、巴西、20241-180
        • IBPClin Instituto Brasil de Pesquisa Clinica
      • São Paulo、巴西、06454-010
        • Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre、Rio Grande do Sul、巴西、90160-093
        • Hospital Ernesto Dornelles
    • São Paulo
      • Botucatu、São Paulo、巴西、18618-686
        • Upeclin-Pesq Clin FacMed Botucatu
      • Santo André、São Paulo、巴西、09060-870
        • Fundacao Abc - Centro Univ Fmabc
      • Santo André、São Paulo、巴西、09030-010
        • Hosp e Maternidade Dr Christovao da Gama
      • Sorocaba、São Paulo、巴西、18040-425
        • Consultoria Medica e Pesquisa Clinica Cmpc
  • 希腊
      • Athens、希腊、12462
        • University General Hospital Attikon
      • Athens、希腊、11521
        • Athens Naval Hospital
      • Athens、希腊、16121
        • Andreas Syngros Hospital Of Venereal And Dermatological Diseases
      • Athens、希腊、11527
        • Thoracic General Hospital Of Athens Sotiria
      • Ioannina、希腊、45500
        • University General Hospital Of Ioannina
      • Larissa、希腊、41110
        • General University Hospital of Larissa
      • Thessaloniki、希腊、56403
        • Papageorgiou General Hospital
  • 德国
      • Berlin、德国、10117
        • Charite - Universitaetsmedizin Berlin, Campus Mitte
      • Blankenfelde-Mahlow、德国、15831
        • Dermatologische Gemeinschaftspraxis-Mahlow
      • Bochum、德国、44793
        • Hautarztpraxis Dr Niesmann und Dr Othlinghaus
      • Darmstadt、德国、64283
        • Rosenpark Research GmbH
      • Dresden、德国、01307
        • Universitaetsklinikum Dresden
      • Düsseldorf、德国、40225
        • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
      • Essen、德国、45174
        • Universitaetsklinikum Essen
      • Hamburg、德国、20246
        • Institute for Health Services Research in Dermatology and Nursing
      • Heidelberg、德国、69120
        • Universitaetsklinikum Heidelberg
      • Stuttgart、德国、70178
        • Hautarztpraxis Dres Leitz und Kollegen
      • Tübingen、德国、72076
        • Universitaetsklinikum Tuebingen
      • Wuppertal、德国、42287
        • CentroDerm GmbH
  • 意大利
      • Chieti、意大利、66100
        • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
      • Milan、意大利、20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Perugia、意大利、06156
        • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
      • Roma、意大利、00161
        • Azienda Ospedaliera Policlinico Umberto I
      • Torino、意大利、10126
        • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
  • 拉脱维亚
      • Riga、拉脱维亚、1003
        • Outpatient clinic Veselibas Centrs 4
      • Riga、拉脱维亚、LV-1013
        • Outpatient clinic Veselibascentrs 4
      • Talsi、拉脱维亚、3201
        • Smite Aija practice in dermatology and venerology
  • 捷克语
      • Náchod、捷克语、547 01
        • Dermamedica, sro
      • Ostrava、捷克语、702 00
        • CCR Ostrava sro
      • Pardubice、捷克语、530 02
        • Pratia Pardubice as
      • Prague、捷克语、180 81
        • Fakultní nemocnice Bulovka
      • Prague、捷克语、100 00
        • Clintrial sro
      • Prague、捷克语、130 00
        • Pratia Prague sro
      • Ústí nad Labem、捷克语、401 13
        • Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
  • 斯洛伐克
      • Banská Bystrica、斯洛伐克、975 17
        • Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
      • Bratislava、斯洛伐克、851 01
        • Derma therapy, spol s ro
      • Svidník、斯洛伐克、089 01
        • Sanare spol sro
      • Topoľčany、斯洛伐克、955 01
        • Kaderma Majtan, sro
      • Trnava、斯洛伐克、917 75
        • Fakultna Nemocnica Trnava
  • 日本
    • Aichi-ken
      • Nagakute-shi、Aichi-ken、日本、480-1195
        • Aichi Medical University Hospital
      • Nagoya、Aichi-ken、日本、467-8602
        • Nagoya City University Hospital
      • Nagoya、Aichi-ken、日本、464-0821
        • Central Clinic
      • Nagoya、Aichi-ken、日本、457-8510
        • Japan Community Healthcare Organization Chukyo Hospital
    • Fukuoka
      • Fukuoka、Fukuoka、日本、819-0373
        • Matsuo Clinic
      • Fukuoka、Fukuoka、日本、814-0180
        • Fukuoka University Hospital
    • Fukushima
      • Fukushima、Fukushima、日本、960-1295
        • Fukushima Medical University Hospital
    • Hokkaido
      • Asahikawa-shi、Hokkaido、日本、070-8610
        • Asahikawa City Hospital
    • Ibaraki
      • Inashiki-gun、Ibaraki、日本、300-0395
        • Tokyo Medical University Ibaraki Medical Center
    • Ishikawa-ken
      • Nonoichi-shi、Ishikawa-ken、日本、921-8801
        • Kaji Dermatology Clinic
    • Iwate
      • Morioka、Iwate、日本、020-8505
        • Iwate Medical University Uchimaru Medical Center
    • Kagawa-ken
      • Marugame-shi、Kagawa-ken、日本、763-0074
        • Takeoka Dermatology Clinic
    • Kanagawa
      • Kawasaki-shi、Kanagawa、日本、211-8533
        • Nippon Medical School Musashikosugi Hospital
    • Kyoto
      • Kyoto、Kyoto、日本、607-8062
        • Rakuwakai Otowa Hospital
      • Kyoto、Kyoto、日本、602-8566
        • University Hospital Kyoto Prefectural University of Medicine
    • Osaka
      • Izumiotsu-shi、Osaka、日本、595-0025
        • Mochida Dermatology Clinic
    • Tochigi
      • Shimotsuga-gun、Tochigi、日本、321-0293
        • Dokkyo Medical University Hospital
    • Tokyo
      • Itabashi-ku、Tokyo、日本、173-8610
        • Nihon University Itabashi Hospital
      • Itabashi-ku、Tokyo、日本、173-8606
        • Teikyo University Hospital
  • 波兰
      • Gdansk、波兰、80-280
        • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
      • Katowice、波兰、40-611
        • Centrum Medyczne Angelius Provita
      • Lublin、波兰、20-080
        • Centrum Zdrowia i Urody Maxxmed
      • Malbork、波兰、82-200
        • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
      • Nowa Sól、波兰、67-100
        • Twoja Przychodnia NCM
      • Poznan、波兰、61-293
        • Twoja Przychodnia PCM
      • Szczecin、波兰、71-500
        • Twoja Przychodnia SCM
      • Tarnów、波兰、33-100
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
      • Warsaw、波兰、02-962
        • Royalderm Agnieszka Nawrocka
      • Wroclaw、波兰、50-450
        • Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
  • 波多黎各
      • San Juan、波多黎各、00909
        • Clinical Research of Puerto Rico
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35244
        • Cahaba Dermatology and Skin Health Center
    • Arizona
      • Phoenix、Arizona、美国、85032
        • Alliance Dermatology and Mohs Center
    • California
      • Anaheim、California、美国、92801
        • Anaheim Clinical Trials
      • Fountain Valley、California、美国、92708
        • First OC Dermatology
      • Glendale、California、美国、91203
        • Kaiser Permanente - Glendale Medical Center
      • Long Beach、California、美国、90805
        • Long Beach Research Institute
      • Los Angeles、California、美国、90045
        • Dermatology Research Associates
      • Los Angeles、California、美国、90027
        • Kaiser Permanente Los Angeles Medical Center
      • Sherman Oaks、California、美国、91403
        • Cura Clinical Research
    • Colorado
      • Centennial、Colorado、美国、80112
        • IMMUNOe Research Centers
    • Florida
      • Boca Raton、Florida、美国、33486
        • Skin Care Research Incorporated
      • Delray Beach、Florida、美国、33484
        • Palm Beach Dermatology Group
      • Homestead、Florida、美国、33030
        • Global Research Associates
      • Miami、Florida、美国、33175
        • Healthy Life Research
      • Miami Lakes、Florida、美国、33014
        • Savin Medical Group LLC
      • Naples、Florida、美国、34102
        • Kirsch Dermatology LLC
      • Orlando、Florida、美国、32819
        • Pure Skin Dermatology and Aesthetics
      • St. Petersburg、Florida、美国、33709
        • Industrial Medicine Associates Ima Clinical Research Inc
      • Tampa、Florida、美国、33606
        • Genesis Clinical Research LLC
    • Idaho
      • Boise、Idaho、美国、83706
        • Treasure Valley Medical Research
    • Illinois
      • Chicago、Illinois、美国、60611
        • DeNova Research
      • West Dundee、Illinois、美国、60118
        • Dundee Dermatology
    • Indiana
      • Plainfield、Indiana、美国、46168
        • The Indiana Clinical Trials Center PC
    • Maryland
      • Chevy Chase、Maryland、美国、20815
        • Institute for Asthma and Allergy
      • Towson、Maryland、美国、21204
        • Continental Clinical Solutions, LLC
    • Michigan
      • Detroit、Michigan、美国、48202
        • Henry Ford Health System
      • Flint、Michigan、美国、48532
        • Onyx Clinical Research
    • Missouri
      • Lee's Summit、Missouri、美国、64064
        • Dermatology and Skin Cancer Center of Lees Summit
    • Nevada
      • Las Vegas、Nevada、美国、89106
        • Jubilee Clinical Research Inc
    • New Hampshire
      • Portsmouth、New Hampshire、美国、03801
        • Allcutis Research, Llc - Portsmouth
    • New Jersey
      • Cherry Hill、New Jersey、美国、08034
        • Continental Clinical Solutions - Cherry Hill
    • New York
      • Hartsdale、New York、美国、10530
        • Industrial Medicine Associates Ima Clinical Research Inc
      • New York、New York、美国、10075
        • Sadick Research Group
    • North Carolina
      • Charlotte、North Carolina、美国、28277
        • Dermatology Specialists of Charlotte
      • Charlotte、North Carolina、美国、28277
        • Onsite Clinical Solutions
      • Wilmington、North Carolina、美国、28405
        • Wilmington Dermatology Center
      • Winston-Salem、North Carolina、美国、27103
        • The Skin Surgery Center for Clinical Research
    • Ohio
      • Boardman、Ohio、美国、44512
        • Optima Research
      • Columbus、Ohio、美国、43213
        • ClinOhio Research Services
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73118
        • Unity Clinical Research
      • Tulsa、Oklahoma、美国、74132
        • Dermatology Research Center of Oklahoma, PLLC
      • Tulsa、Oklahoma、美国、74137
        • Essential Medical Research LLC
    • Oregon
      • Portland、Oregon、美国、97239
        • Oregon Health and Science University
    • Pennsylvania
      • Sugarloaf、Pennsylvania、美国、18249
        • DermDox Dermatology, LLC
    • Tennessee
      • Hermitage、Tennessee、美国、37076
        • Cumberland Skin Center
    • Texas
      • Dallas、Texas、美国、75230
        • Dermatology Treatment and Research Center PA
      • The Woodlands、Texas、美国、77380
        • The Woodlands Dermatology Associates
    • Virginia
      • Lynchburg、Virginia、美国、24501
        • Education and Research Foundation Inc
    • Washington
      • Mill Creek、Washington、美国、98012
        • Frontier Derm Partners
    • West Virginia
      • Morgantown、West Virginia、美国、26505
        • West Virginia Research Institute
  • 荷兰
      • Born、荷兰、6121 XK
        • PreCare Trial and Recruitment
  • 葡萄牙
      • Lisbon、葡萄牙、1998-018
        • Hospital CUF Descobertas
      • Lisbon、葡萄牙、1500-458
        • Hospital Lusiadas Lisboa
      • Matosinhos Municipality、葡萄牙、4464-513
        • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
      • Porto、葡萄牙、4099-001
        • Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
  • 西班牙
      • Madrid、西班牙、28006
        • Hospital Universitario de La Princesa
      • Madrid、西班牙、28031
        • Hospital Universitario Infanta Leonor
    • Andalusia
      • Córdoba、Andalusia、西班牙、14004
        • Hospital Universitario Reina Sofia
    • Aragon
      • Zaragoza、Aragon、西班牙、50009
        • Hospital Universitario Miguel Servet
    • Canary Islands
      • Las Palmas de Gran Canaria、Canary Islands、西班牙、35010
        • Hospital Universitario de Gran Canaria Doctor Negrin
    • Catalonia
      • Badalona、Catalonia、西班牙、08916
        • Hospital Universitari Germans Trias i Pujol
      • L'Hospitalet de Llobregat、Catalonia、西班牙、08907
        • Hospital Universitari de Bellvitge
    • Galicia
      • Pontevedra、Galicia、西班牙、36001
        • Hospital Clínico Universitario de Santiago
    • Madrid
      • Pozuelo de Alarcón、Madrid、西班牙、28223
        • Hospital Universitario Quironsalud Madrid
    • Valencia
      • Valencia、Valencia、西班牙、46026
        • Hospital Universitari i Politecnic La Fe
  • 阿根廷
    • Buenos Aires
      • CABA、Buenos Aires、阿根廷、C1027AAP
        • CINME - Centro De Investigaciones Metabolicas
      • Ciudad Autonoma de Buenos Aires、Buenos Aires、阿根廷、C1426ABP
        • Fundacion Respirar
      • Derqui, Pilar、Buenos Aires、阿根廷、B1629ODT
        • Hospital Universitario Austral
      • San Miguel、Buenos Aires、阿根廷、1663
        • Centro Dermatologico Schejtman
    • Distrito Federal
      • Buenos Aires、Distrito Federal、阿根廷、1425
        • Instituto de Neumonología Y Dermatología
      • Buenos Aires、Distrito Federal、阿根廷、1425
        • InAER - Investigaciones en Alergia y Enfermedades Respiratorias
      • CABA、Distrito Federal、阿根廷、C1012AAY
        • Conexa Investigacion Clinica SA
    • Santa Fe Province
      • Rosario、Santa Fe Province、阿根廷、2000
        • Fundacion Estudios Clinicos
      • Rosario、Santa Fe Province、阿根廷、2000
        • Instituto de Diagnostico Abc American British Cowdray
  • 韩国
      • Ansansi, Gyeonggido、韩国、15355
        • Korea University Ansan Hospital
      • Incheon、韩国、21431
        • The Catholic University of Korea Incheon St Marys Hospital
      • Seoul、韩国、03080
        • Seoul National University Hospital
      • Seoul、韩国、05505
        • Asan Medical Center
      • Seoul、韩国、08308
        • Korea University Guro Hospital
      • Seoul、韩国、04564
        • National Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 年龄≥18 岁，根据 AAD 共识标准 (2014) 诊断为 AD 至少 6 个月
  • 6 个月内对中等或更高效力的 TCS（局部皮质类固醇）反应不足的历史（有或没有局部钙调神经磷酸酶抑制剂 [TCI]）
  • EASI评分≥16
  • vIGA-AD评分≥3
  • ≥10% 的 AD 受累体表面积 (BSA)
  • 最严重的瘙痒评分量表 ≥ 4

排除标准：

  • 在第 1 天之前，在 12 周或 5 个半衰期（以较长者为准）内使用生物制品进行治疗

  • 在第 1 天之前的 4 周或 5 个半衰期（以较长者为准）内使用以下任何药物或疗法进行治疗：

    • 全身皮质类固醇
    • 全身免疫抑制剂
    • 光疗
    • Janus 激酶抑制剂

  • 在第 1 天之前的 1 周内使用以下任何药物或疗法进行治疗：

    • 任何效力的 TCS
    • TCI公司
    • 止痒药
    • 局部磷酸二酯酶 4 抑制剂
    • 其他外用免疫抑制剂

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：手臂A
Rocatinlimab 每 4 周 (Q4W) 剂量 1 + 第 2 周的负荷剂量
药品：罗卡汀利马布
参与者将皮下注射 Rocatinlimab。
其他名称：
  • AMG 451
实验性的：B臂
Rocatinlimab 剂量 2 Q4W + 第 2 周的负荷剂量
药品：罗卡汀利马布
参与者将皮下注射 Rocatinlimab。
其他名称：
  • AMG 451
安慰剂比较：C臂
第 2 周安慰剂 Q4W+ 负荷剂量
药品：安慰剂
参与者将接受皮下安慰剂。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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.
Baseline and Week 24
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
大体时间：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.
Baseline and Week 24

次要结果测量

结果测量
措施说明
大体时间
Number of Participants Who Achieved EASI 75 at Week 16
大体时间：Baseline and Week 16
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.
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
大体时间：Baseline and Week 16
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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
大体时间：Baseline and Week 24
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
大体时间：Baseline and Week 24
The 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 90 was defined as a ≥ 90% improvement from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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
大体时间：Baseline and Week 24
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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
大体时间：Baseline and Week 24
The severity of facial AD was assessed using the Facial AD Severity Scale (FASS). The FASS was an instrument used to rate the overall severity of facial AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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
大体时间：Baseline and Week 24
The severity of hand AD was assessed using the Hand Atopic Dermatitis Severity Scale (HASS). The HASS was an instrument used to rate the overall severity of hand AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
大体时间：Baseline and Week 16
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward [WOCF]) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Baseline and Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
大体时间：Baseline and Week 24
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
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
大体时间：Baseline and Week 24
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adult patients suffering from skin disease. The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in DLQI Score at Week 24
大体时间：Baseline and Week 24
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adult patients suffering from skin disease. The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
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
大体时间：Baseline and Week 24
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in POEM Score at Week 24
大体时间：Baseline and Week 24
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
大体时间：Baseline and Week 24
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
大体时间：Baseline and Week 16
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
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
大体时间：Baseline and Week 24
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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
大体时间：Baseline and Week 16
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
大体时间：Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in HADS-anxiety Subscale Score at Week 24
大体时间：Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Baseline and Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24
大体时间：Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
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
大体时间：Baseline and Week 24
The SCORAD total score used to assess the severity of AD using both physician and patient-reported data. SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved vIGA-AD 0/1 at Week 16
大体时间：Baseline and Week 16
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
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
大体时间：Baseline and Week 24
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
大体时间：Baseline and Week 16
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Baseline and Week 16
Change From Baseline in SCORAD Itch VAS Score at Week 24
大体时间：Baseline and Week 24
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
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
大体时间：Baseline and Week 16
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
大体时间：Baseline and Week 24
Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours. Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance. Participants were asked to rate the intensity of their sleep disturbance using this scale each day. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in level of sleep disturbance.
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
大体时间：Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-anxiety subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

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调查人员

  • 研究主任：MD、Amgen

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年5月31日

初级完成 (实际的)

2024年11月28日

研究完成 (实际的)

2025年1月13日

研究注册日期

首次提交

2022年5月24日

首先提交符合 QC 标准的

2022年5月31日

首次发布 (实际的)

2022年6月1日

研究记录更新

最后更新发布 (实际的)

2026年7月23日

上次提交的符合 QC 标准的更新

2026年6月25日

最后验证

2026年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 20210142
  • 2022-501540-15-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

在已批准的数据共享请求中，为解决特定研究问题所需的变量取消识别个体患者数据。

IPD 共享时间框架

与本研究相关的数据共享请求将在研究结束后 18 个月开始考虑，并且 1) 产品和适应症已在美国和欧洲获得上市许可，或 2) 产品和/或适应症的临床开发停止并且数据不会提交给监管机构。 没有资格为本研究提交数据共享请求的截止日期。

IPD 共享访问标准

合格的研究人员可以提交包含研究目标、Amgen 产品和 Amgen 研究/研究范围、终点/感兴趣的结果、统计分析计划、数据要求、出版计划和研究人员资格的请求。 一般而言，安进公司不会出于重新评估产品标签中已解决的安全性和有效性问题的目的而批准对个别患者数据的外部请求。 请求由内部顾问委员会审查。 如果未获批准，数据共享独立审查小组将进行仲裁并做出最终决定。 经批准后，将根据数据共享协议的条款提供解决研究问题所需的信息。 这可能包括匿名的个体患者数据和/或可用的支持文件，其中包含分析规范中提供的分析代码片段。 更多详细信息，请访问以下 URL。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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