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中等度から重度のアトピー性皮膚炎におけるロカチンリマブを評価する研究 (ROCKET-IGNITE) (ROCKET-Ignite)

2026年6月25日更新者：Amgen

中等度から重度のアトピー性皮膚炎（AD）の成人被験者におけるロカチンリマブ（AMG 451）単剤療法の有効性、安全性、忍容性を評価するための第3相、24週間、無作為化、プラセボ対照、二重盲検試験

この研究の目的は、単剤療法におけるロカチンリマブの有効性と安全性を評価することです。

調査の概要

状態

完了

条件

アトピー性皮膚炎

介入・治療

研究の種類

介入

入学 (実際)

769

段階

フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

アメリカ
- Alabama
  - Birmingham、Alabama、アメリカ、35244
    - Cahaba Dermatology and Skin Health Center
- Arizona
  - Phoenix、Arizona、アメリカ、85032
    - Alliance Dermatology and Mohs Center
- California
  - Anaheim、California、アメリカ、92801
    - Anaheim Clinical Trials
  - Fountain Valley、California、アメリカ、92708
    - First Oc Dermatology
  - Glendale、California、アメリカ、91203
    - Kaiser Permanente - Glendale Medical Center
  - Long Beach、California、アメリカ、90805
    - Long Beach Research Institute
  - Los Angeles、California、アメリカ、90045
    - Dermatology Research Associates
  - Los Angeles、California、アメリカ、90027
    - Kaiser Permanente Los Angeles Medical Center
  - Sherman Oaks、California、アメリカ、91403
    - Cura Clinical Research
- Colorado
  - Centennial、Colorado、アメリカ、80112
    - IMMUNOe Research Centers
- Florida
  - Boca Raton、Florida、アメリカ、33486
    - Skin Care Research Incorporated
  - Delray Beach、Florida、アメリカ、33484
    - Palm Beach Dermatology Group
  - Homestead、Florida、アメリカ、33030
    - Global Research Associates
  - Miami、Florida、アメリカ、33175
    - Healthy Life Research
  - Miami Lakes、Florida、アメリカ、33014
    - Savin Medical Group LLC
  - Naples、Florida、アメリカ、34102
    - Kirsch Dermatology LLC
  - Orlando、Florida、アメリカ、32819
    - Pure Skin Dermatology and Aesthetics
  - St. Petersburg、Florida、アメリカ、33709
    - Industrial Medicine Associates Ima Clinical Research Inc
  - Tampa、Florida、アメリカ、33606
    - Genesis Clinical Research LLC
- Idaho
  - Boise、Idaho、アメリカ、83706
    - Treasure Valley Medical Research
- Illinois
  - Chicago、Illinois、アメリカ、60611
    - DeNova Research
  - West Dundee、Illinois、アメリカ、60118
    - Dundee Dermatology
- Indiana
  - Plainfield、Indiana、アメリカ、46168
    - The Indiana Clinical Trials Center PC
- Maryland
  - Chevy Chase、Maryland、アメリカ、20815
    - Institute for Asthma and Allergy
  - Towson、Maryland、アメリカ、21204
    - Continental Clinical Solutions, LLC
- Michigan
  - Detroit、Michigan、アメリカ、48202
    - Henry Ford Health System
  - Flint、Michigan、アメリカ、48532
    - Onyx Clinical Research
- Missouri
  - Lee's Summit、Missouri、アメリカ、64064
    - Dermatology and Skin Cancer Center of Lees Summit
- Nevada
  - Las Vegas、Nevada、アメリカ、89106
    - Jubilee Clinical Research Inc
- New Hampshire
  - Portsmouth、New Hampshire、アメリカ、03801
    - Allcutis Research, Llc - Portsmouth
- New Jersey
  - Cherry Hill、New Jersey、アメリカ、08034
    - Continental Clinical Solutions - Cherry Hill
- New York
  - Hartsdale、New York、アメリカ、10530
    - Industrial Medicine Associates Ima Clinical Research Inc
  - New York、New York、アメリカ、10075
    - Sadick Research Group
- North Carolina
  - Charlotte、North Carolina、アメリカ、28277
    - Dermatology Specialists of Charlotte
  - Charlotte、North Carolina、アメリカ、28277
    - Onsite Clinical Solutions
  - Wilmington、North Carolina、アメリカ、28405
    - Wilmington Dermatology Center
  - Winston-Salem、North Carolina、アメリカ、27103
    - The Skin Surgery Center for Clinical Research
- Ohio
  - Boardman、Ohio、アメリカ、44512
    - Optima Research
  - Columbus、Ohio、アメリカ、43213
    - ClinOhio Research Services
- Oklahoma
  - Oklahoma City、Oklahoma、アメリカ、73118
    - Unity Clinical Research
  - Tulsa、Oklahoma、アメリカ、74132
    - Dermatology Research Center of Oklahoma, PLLC
  - Tulsa、Oklahoma、アメリカ、74137
    - Essential Medical Research LLC
- Oregon
  - Portland、Oregon、アメリカ、97239
    - Oregon Health and Science University
- Pennsylvania
  - Sugarloaf、Pennsylvania、アメリカ、18249
    - DermDox Dermatology, LLC
- Tennessee
  - Hermitage、Tennessee、アメリカ、37076
    - Cumberland Skin Center
- Texas
  - Dallas、Texas、アメリカ、75230
    - Dermatology Treatment and Research Center PA
  - The Woodlands、Texas、アメリカ、77380
    - The Woodlands Dermatology Associates
- Virginia
  - Lynchburg、Virginia、アメリカ、24501
    - Education and Research Foundation Inc
- Washington
  - Mill Creek、Washington、アメリカ、98012
    - Frontier Derm Partners
- West Virginia
  - Morgantown、West Virginia、アメリカ、26505
    - West Virginia Research Institute
アルゼンチン
- Buenos Aires
  - CABA、Buenos Aires、アルゼンチン、C1027AAP
    - CINME - Centro De Investigaciones Metabolicas
  - Ciudad Autonoma de Buenos Aires、Buenos Aires、アルゼンチン、C1426ABP
    - Fundacion Respirar
  - Derqui, Pilar、Buenos Aires、アルゼンチン、B1629ODT
    - Hospital Universitario Austral
  - San Miguel、Buenos Aires、アルゼンチン、1663
    - Centro Dermatologico Schejtman
- Distrito Federal
  - Buenos Aires、Distrito Federal、アルゼンチン、1425
    - Instituto de Neumonología Y Dermatología
  - Buenos Aires、Distrito Federal、アルゼンチン、1425
    - InAER - Investigaciones en Alergia y Enfermedades Respiratorias
  - CABA、Distrito Federal、アルゼンチン、C1012AAY
    - Conexa Investigacion Clinica SA
- Santa Fe Province
  - Rosario、Santa Fe Province、アルゼンチン、2000
    - Fundacion Estudios Clinicos
  - Rosario、Santa Fe Province、アルゼンチン、2000
    - Instituto de Diagnostico Abc American British Cowdray
イタリア
- - Chieti、イタリア、66100
    - Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
  - Milan、イタリア、20122
    - Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  - Perugia、イタリア、06156
    - Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
  - Roma、イタリア、00161
    - Azienda Ospedaliera Policlinico Umberto I
  - Torino、イタリア、10126
    - Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
オランダ
- - Born、オランダ、6121 XK
    - PreCare Trial and Recruitment
カナダ
- Alberta
  - Edmonton、Alberta、カナダ、T6G 1C3
    - Alberta Derma Surgery Centre
  - Edmonton、Alberta、カナダ、T6H 4J8
    - Vida Clinical Research
- Ontario
  - Ajax、Ontario、カナダ、L1S 7K8
    - CCA Medical Research Corporation
  - Barrie、Ontario、カナダ、L4M 7G1
    - SimcoDerm Medical and Surgical Dermatology Centre
  - Hamilton、Ontario、カナダ、L8L 3C3
    - Leader Research
  - Mississauga、Ontario、カナダ、L4Y 4C5
    - DermEdge Research Incorporated
  - North York、Ontario、カナダ、M3B 3S6
    - Gordon Sussman Clinical Research Incorporated
  - North York、Ontario、カナダ、M3B 0A7
    - Canadian Dermatology Centre
  - Richmond Hill、Ontario、カナダ、L4E 4L6
    - Oak Ridges Aesthetics Centre
- Quebec
  - Montreal、Quebec、カナダ、H2X 2V1
    - Innovaderm Research Inc
  - Québec、Quebec、カナダ、G1G 3Y8
    - Recherche Clinique Sigma Incorporated
- Saskatchewan
  - Saskatoon、Saskatchewan、カナダ、S7K 2C1
    - Skinsense Medical Research
ギリシャ
- - Athens、ギリシャ、12462
    - University General Hospital Attikon
  - Athens、ギリシャ、11521
    - Athens Naval Hospital
  - Athens、ギリシャ、16121
    - Andreas Syngros Hospital Of Venereal And Dermatological Diseases
  - Athens、ギリシャ、11527
    - Thoracic General Hospital Of Athens Sotiria
  - Ioannina、ギリシャ、45500
    - University General Hospital Of Ioannina
  - Larissa、ギリシャ、41110
    - General University Hospital of Larissa
  - Thessaloniki、ギリシャ、56403
    - Papageorgiou General Hospital
クロアチア
- - Ivanić-Grad、クロアチア、10310
    - Special Hospital for Medical Rehabilitation Naftalan
  - Zagreb、クロアチア、10000
    - University Hospital Centre Zagreb
  - Zagreb、クロアチア、10000
    - Sestre milosrdnice University Hospital Center
スペイン
- - Madrid、スペイン、28006
    - Hospital Universitario de la Princesa
  - Madrid、スペイン、28031
    - Hospital Universitario Infanta Leonor
- Andalusia
  - Córdoba、Andalusia、スペイン、14004
    - Hospital Universitario Reina Sofía
- Aragon
  - Zaragoza、Aragon、スペイン、50009
    - Hospital Universitario Miguel Servet
- Canary Islands
  - Las Palmas de Gran Canaria、Canary Islands、スペイン、35010
    - Hospital Universitario de Gran Canaria Doctor Negrin
- Catalonia
  - Badalona、Catalonia、スペイン、08916
    - Hospital Universitari Germans Trias i Pujol
  - L'Hospitalet de Llobregat、Catalonia、スペイン、08907
    - Hospital Universitari de Bellvitge
- Galicia
  - Pontevedra、Galicia、スペイン、36001
    - Hospital Clínico Universitario de Santiago
- Madrid
  - Pozuelo de Alarcón、Madrid、スペイン、28223
    - Hospital Universitario Quironsalud Madrid
- Valencia
  - Valencia、Valencia、スペイン、46026
    - Hospital Universitari i Politècnic La Fe
スロバキア
- - Banská Bystrica、スロバキア、975 17
    - Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
  - Bratislava、スロバキア、851 01
    - Derma therapy, spol s ro
  - Svidník、スロバキア、089 01
    - Sanare spol sro
  - Topoľčany、スロバキア、955 01
    - Kaderma Majtan, sro
  - Trnava、スロバキア、917 75
    - Fakultna Nemocnica Trnava
チェコ
- - Náchod、チェコ、547 01
    - Dermamedica, sro
  - Ostrava、チェコ、702 00
    - CCR Ostrava sro
  - Pardubice、チェコ、530 02
    - Pratia Pardubice as
  - Prague、チェコ、180 81
    - Fakultni nemocnice Bulovka
  - Prague、チェコ、100 00
    - Clintrial sro
  - Prague、チェコ、130 00
    - Pratia Prague sro
  - Ústí nad Labem、チェコ、401 13
    - Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
ドイツ
- - Berlin、ドイツ、10117
    - Charite - Universitaetsmedizin Berlin, Campus Mitte
  - Blankenfelde-Mahlow、ドイツ、15831
    - Dermatologische Gemeinschaftspraxis-Mahlow
  - Bochum、ドイツ、44793
    - Hautarztpraxis Dr Niesmann und Dr Othlinghaus
  - Darmstadt、ドイツ、64283
    - Rosenpark Research GmbH
  - Dresden、ドイツ、01307
    - Universitaetsklinikum Dresden
  - Düsseldorf、ドイツ、40225
    - Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
  - Essen、ドイツ、45174
    - Universitaetsklinikum Essen
  - Hamburg、ドイツ、20246
    - Institute for Health Services Research in Dermatology and Nursing
  - Heidelberg、ドイツ、69120
    - Universitaetsklinikum Heidelberg
  - Stuttgart、ドイツ、70178
    - Hautarztpraxis Dres Leitz und Kollegen
  - Tübingen、ドイツ、72076
    - Universitaetsklinikum Tuebingen
  - Wuppertal、ドイツ、42287
    - CentroDerm GmbH
ハンガリー
- - Veszprém、ハンガリー、8200
    - MedMare Bt
ブラジル
- - Rio de Janeiro、ブラジル、20241-180
    - IBPClin Instituto Brasil de Pesquisa Clinica
  - São Paulo、ブラジル、06454-010
    - Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
- Rio Grande do Sul
  - Porto Alegre、Rio Grande do Sul、ブラジル、90035-903
    - Hospital de Clínicas de Porto Alegre
  - Porto Alegre、Rio Grande do Sul、ブラジル、90160-093
    - Hospital Ernesto Dornelles
- São Paulo
  - Botucatu、São Paulo、ブラジル、18618-686
    - Upeclin-Pesq Clin FacMed Botucatu
  - Santo André、São Paulo、ブラジル、09060-870
    - Fundacao Abc - Centro Univ Fmabc
  - Santo André、São Paulo、ブラジル、09030-010
    - Hosp e Maternidade Dr Christovao da Gama
  - Sorocaba、São Paulo、ブラジル、18040-425
    - Consultoria Medica e Pesquisa Clinica Cmpc
プエルトリコ
- - San Juan、プエルトリコ、00909
    - Clinical Research of Puerto Rico
ポルトガル
- - Lisbon、ポルトガル、1998-018
    - Hospital CUF Descobertas
  - Lisbon、ポルトガル、1500-458
    - Hospital Lusiadas Lisboa
  - Matosinhos Municipality、ポルトガル、4464-513
    - Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
  - Porto、ポルトガル、4099-001
    - Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
ポーランド
- - Gdansk、ポーランド、80-280
    - AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
  - Katowice、ポーランド、40-611
    - Centrum Medyczne Angelius Provita
  - Lublin、ポーランド、20-080
    - Centrum Zdrowia i Urody Maxxmed
  - Malbork、ポーランド、82-200
    - Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
  - Nowa Sól、ポーランド、67-100
    - Twoja Przychodnia NCM
  - Poznan、ポーランド、61-293
    - Twoja Przychodnia PCM
  - Szczecin、ポーランド、71-500
    - Twoja Przychodnia SCM
  - Tarnów、ポーランド、33-100
    - Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
  - Warsaw、ポーランド、02-962
    - Royalderm Agnieszka Nawrocka
  - Wroclaw、ポーランド、50-450
    - Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
ラトビア
- - Riga、ラトビア、1003
    - Outpatient clinic Veselibas Centrs 4
  - Riga、ラトビア、LV-1013
    - Outpatient clinic Veselibascentrs 4
  - Talsi、ラトビア、3201
    - Smite Aija practice in dermatology and venerology
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
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
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
韓国
- - Ansansi, Gyeonggido、韓国、15355
    - Korea University Ansan Hospital
  - Incheon、韓国、21431
    - The Catholic University of Korea Incheon St Marys Hospital
  - Seoul、韓国、03080
    - Seoul National University Hospital
  - Seoul、韓国、05505
    - Asan Medical Center
  - Seoul、韓国、08308
    - Korea University Guro Hospital
  - Seoul、韓国、04564
    - National Medical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～100年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

包含基準:

-AADコンセンサス基準（2014）に従ってADと診断された18歳以上の年齢少なくとも6か月間存在する
-6か月以内に中程度以上の効力のTCS（局所コルチコステロイド）に対する不十分な反応の病歴（局所カルシニューリン阻害剤[TCI]の有無にかかわらず）
EASIスコア≧16
vIGA-ADスコア≧3
AD関与の体表面積（BSA）が10%以上
最悪のかゆみの数値評価尺度 ≥ 4

除外基準:

-1日目の前の12週間または5半減期のいずれか長い方以内の生物学的製剤による治療
-1日目の前の4週間または5半減期のいずれか長い方以内に、次の薬物療法または療法のいずれかによる治療：
- 全身性コルチコステロイド
- 全身性免疫抑制剤
- 光線療法
- ヤヌスキナーゼ阻害剤
-1日目の前の1週間以内に、次の薬物療法または治療法のいずれかによる治療：
- あらゆる効能のTCS
- TCI
- 鎮痒剤
- 外用ホスホジエステラーゼ4型阻害剤
- その他の外用免疫抑制剤

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

主な目的：処理
割り当て：ランダム化
介入モデル：並列代入
マスキング：ダブル

アーム数

武器と介入

参加者グループ / アーム	介入・治療
実験的：アームA ロカチンリマブを 4 週間ごとに 1 回投与 (Q4W) + 2 週目に負荷投与	薬：ロカチンリマブ参加者はロカチンリマブを皮下投与されます。他の名前： AMG 451
実験的：アームB ロカチンリマブ用量 2 Q4W + 2 週目の負荷用量	薬：ロカチンリマブ参加者はロカチンリマブを皮下投与されます。他の名前： AMG 451
プラセボコンパレーター：アームC 第 2 週のプラセボ Q4W+ ローディング用量	薬：プラセボ参加者は皮下にプラセボを受け取ります。

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
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 時間枠：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 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Number of Participants Who Achieved EASI 75 at Week 16 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Amgen

捜査官

スタディディレクター：MD、Amgen

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

AmgenTrials clinical trials website

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年5月31日

一次修了 (実際)

2024年11月28日

研究の完了 (実際)

2025年1月13日

試験登録日

最初に提出

2022年5月24日

QC基準を満たした最初の提出物

2022年5月31日

最初の投稿 (実際)

2022年6月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月23日

QC基準を満たした最後の更新が送信されました

2026年6月25日

最終確認日

2026年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

20210142
2022-501540-15-00 (Ctis)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

承認されたデータ共有リクエストで特定の研究課題に対処するために必要な変数の匿名化された個々の患者データ。

IPD 共有時間枠

この研究に関連するデータ共有リクエストは、研究が終了してから 18 か月後に開始されると見なされ、1) 米国とヨーロッパの両方で製品と適応症に販売承認が付与されているか、2) 製品および/または適応症の臨床開発が中止されています。データは規制当局に提出されません。この調査のデータ共有リクエストを送信する資格の終了日はありません。

IPD 共有アクセス基準

有資格の研究者は、研究目的、範囲内の Amgen 製品および Amgen 研究/研究、関心のあるエンドポイント/結果、統計分析計画、データ要件、出版計画、および研究者の資格を含む要求を提出することができます。一般に、アムジェン社は、製品ラベルですでに対処されている安全性と有効性の問題を再評価する目的で、個々の患者データに対する外部からの要求を許可しません. 要求は、内部アドバイザーの委員会によって審査されます。承認されない場合、データ共有の独立審査委員会が仲裁を行い、最終決定を下します。承認されると、研究課題に対処するために必要な情報が、データ共有契約の条件に基づいて提供されます。これには、匿名化された個々の患者データおよび/または分析仕様で提供される分析コードのフラグメントを含む利用可能なサポートドキュメントが含まれる場合があります。詳細は下記ＵＲＬにて。

IPD 共有サポート情報タイプ

STUDY_PROTOCOL
SAP
ICF
CSR

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

中等度から重度のアトピー性皮膚炎におけるロカチンリマブを評価する研究 (ROCKET-IGNITE) (ROCKET-Ignite)

中等度から重度のアトピー性皮膚炎（AD）の成人被験者におけるロカチンリマブ（AMG 451）単剤療法の有効性、安全性、忍容性を評価するための第3相、24週間、無作為化、プラセボ対照、二重盲検試験

調査の概要

状態

条件

介入・治療

研究の種類

入学 (実際)

段階

連絡先と場所

研究場所

参加基準

適格基準

就学可能な年齢

健康ボランティアの受け入れ

説明

研究計画

研究はどのように設計されていますか？

デザインの詳細

アーム数

武器と介入

参加者グループ / アーム

介入・治療

この研究は何を測定していますか？

主要な結果の測定

結果測定

メジャーの説明

時間枠

二次結果の測定

結果測定

メジャーの説明

時間枠

協力者と研究者

スポンサー

捜査官

出版物と役立つリンク

一般刊行物

便利なリンク

研究記録日

主要日程の研究

研究開始 (実際)

一次修了 (実際)

研究の完了 (実際)

試験登録日

最初に提出

QC基準を満たした最初の提出物

最初の投稿 (実際)

学習記録の更新

投稿された最後の更新 (実際)

QC基準を満たした最後の更新が送信されました

最終確認日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

IPD プランの説明

IPD 共有時間枠

IPD 共有アクセス基準

IPD 共有サポート情報タイプ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

米国FDA規制機器製品の研究