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中等度から重度のアトピー性皮膚炎（AD）におけるロカチンリマブ（AMG 451）単剤療法を評価する第3相プラセボ対照二重盲検試験（ROCKET-Horizon） (ROCKET-Horizon)

2026年6月2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、無作為化、24週間、プラセボ対照、二重盲検試験（ROCKET-地平線）

この研究の主な目的は次のとおりです。

Validated Investigator's Global Assessment for Attopic Dermatitis (vIGA-AD) を使用して評価された、24 週目のプラセボと比較したロカチンリマブの有効性を評価します。
湿疹面積および重症度指数 (EASI) を使用して評価された、24 週目のプラセボと比較したロカチンリマブの有効性を評価します。

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)

726

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
- Arizona
  - Litchfield Park、Arizona、アメリカ、85340
    - Research Solutions of Arizona, PC
  - Scottsdale、Arizona、アメリカ、85260
    - Center for Dermatology and Plastic Surgery
- Arkansas
  - Fayetteville、Arkansas、アメリカ、72703
    - Clinical Trials Institute of Northwest Arkansas
  - Hot Springs、Arkansas、アメリカ、71913
    - Burke Pharmaceutical Research
- California
  - Chula Vista、California、アメリカ、91911
    - Velocity Clinical Research Chula Vista
  - Dublin、California、アメリカ、94568
    - West Coast Research LLC
  - Encinitas、California、アメリカ、92024
    - California Dermatology and Clinical Research Institute
  - Fremont、California、アメリカ、94538
    - Center for Dermatology Clinical Research Inc
  - La Mesa、California、アメリカ、91942
    - Velocity Clinical Research - San Diego
  - North Hollywood、California、アメリカ、91606
    - Velocity Clinical Research - North Hollywood
  - Palmdale、California、アメリカ、93551
    - Cura Clinical Research
  - San Francisco、California、アメリカ、94115
    - University of California at San Francisco, Dermatology Clinic at Mount Zion
  - Santa Monica、California、アメリカ、90404
    - Clinical Science Institute
- Colorado
  - Castle Rock、Colorado、アメリカ、80109
    - Clarity Dermatology
  - Denver、Colorado、アメリカ、80209
    - Velocity Clinical Research - Denver
- District of Columbia
  - Washington D.C.、District of Columbia、アメリカ、20016
    - Foxhall Research Center
- Florida
  - Cape Coral、Florida、アメリカ、33991
    - Renaissance Research and Medical Group
  - Coral Gables、Florida、アメリカ、33134
    - Driven Research LLC
  - Doral、Florida、アメリカ、33172
    - Saint Jude Clinical Research
  - Hialeah、Florida、アメリカ、33012
    - Direct Helpers Research Center
  - Margate、Florida、アメリカ、33063
    - Glick Skin Institute
  - Miami、Florida、アメリカ、33176
    - Miami Dade Medical Research Institute, LLC
  - Palmetto Bay、Florida、アメリカ、33157
    - Innovation Medical Research Center Inc
  - Tampa、Florida、アメリカ、33612
    - University of South Florida Health Morsani Center for Advanced Healthcare
- Georgia
  - Sandy Springs、Georgia、アメリカ、30328
    - Advanced Medical Research Pc
- Illinois
  - Normal、Illinois、アメリカ、61761
    - Sneeze, Wheeze, and Itch Associates, LLC
- Indiana
  - South Bend、Indiana、アメリカ、46617
    - The South Bend Clinic LLP
  - West Lafayette、Indiana、アメリカ、47906
    - Options Research Group LLC
- Kansas
  - Overland Park、Kansas、アメリカ、66223
    - Dermatology and Skin Cancer Center of Overland Park
- Kentucky
  - Louisville、Kentucky、アメリカ、40241
    - DS Research
  - Murray、Kentucky、アメリカ、42071
    - Kentucky Advanced Medical Research LLC
- Massachusetts
  - Brighton、Massachusetts、アメリカ、02135
    - MetroBoston Clinical Partners
- Michigan
  - Farmington Hills、Michigan、アメリカ、48334
    - Wendy Sadoff MD Dermatology PC
  - Troy、Michigan、アメリカ、48084
    - Somerset Skin Centre
  - Troy、Michigan、アメリカ、48084
    - Revival Research Institute LLC
- Nebraska
  - Omaha、Nebraska、アメリカ、68144
    - Advanced Dermatology of the Midlands
- Nevada
  - Las Vegas、Nevada、アメリカ、89117
    - James Del Rosso Dermatology Research
  - Reno、Nevada、アメリカ、89509
    - Skin Cancer and Dermatology Institute
- New Hampshire
  - Lebanon、New Hampshire、アメリカ、03766
    - Dartmouth-Hitchcock Medical Center
- New Jersey
  - Riverdale、New Jersey、アメリカ、07457
    - Weiss Medical
- New York
  - Horseheads、New York、アメリカ、14845
    - Corning Center for Clinical Research
  - Kew Gardens、New York、アメリカ、11415
    - Forest Hills Dermatology Group
  - Monroe、New York、アメリカ、10950
    - Crystal Run Healthcare
  - New York、New York、アメリカ、10029
    - Icahn School of Medicine at Mount Sinai
  - New York、New York、アメリカ、10022
    - Ace Clinical Trials
  - New York、New York、アメリカ、10128
    - OptiSkin Medical
  - The Bronx、New York、アメリカ、10467
    - Montefiore Medical Center
- North Carolina
  - Durham、North Carolina、アメリカ、27713
    - Duke South Durham
- Ohio
  - Cincinnati、Ohio、アメリカ、45219
    - University of Cincinnati
  - Cincinnati、Ohio、アメリカ、45236
    - Bernstein Clinical Research Center LLC
  - Gahanna、Ohio、アメリカ、43230
    - The Ohio State University Dermatology East
- Oregon
  - Grants Pass、Oregon、アメリカ、97527
    - Velocity Clinical Research - Grants Pass
  - Portland、Oregon、アメリカ、97223
    - Oregon Medical Research Center
- Rhode Island
  - Warwick、Rhode Island、アメリカ、02886
    - Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
- Texas
  - Bellaire、Texas、アメリカ、77401
    - Bellaire Dermatology Associates
  - Cedar Park、Texas、アメリカ、78613
    - US Dermatology Partners Cedar Park
  - Dallas、Texas、アメリカ、75225
    - Alina Clinical Trials, LLC
  - Dallas、Texas、アメリカ、75230
    - Zenos Clinical Research, LLC
  - Houston、Texas、アメリカ、77030
    - The University of Texas Health Science Center at Houston
  - Houston、Texas、アメリカ、77037
    - MedCare Pharma - Houston
  - Lampasas、Texas、アメリカ、76550
    - FMCScience LLC
  - Lewisville、Texas、アメリカ、75057
    - Epic Clinical Research Incorporated
  - Missouri City、Texas、アメリカ、77459
    - Sienna Dermatology Research
  - San Antonio、Texas、アメリカ、78218
    - Texas Dermatology and Laser Specialists
  - San Antonio、Texas、アメリカ、78229
    - Dermatology Clinical Research Center of San Antonio
  - San Antonio、Texas、アメリカ、78229
    - Andante Research
- Utah
  - Murray、Utah、アメリカ、84107
    - University of Utah Midvalley Dermatology
- Virginia
  - Norfolk、Virginia、アメリカ、23507
    - Eastern Virginia Medical School
- Washington
  - Spokane、Washington、アメリカ、99202
    - MultiCare Institute for Research and Innovation
イギリス
- - Corby、イギリス、NN17 2UR
    - Lakeside Healthcare
  - London、イギリス、SE1 9RT
    - Guys Hospital
  - Southampton、イギリス、SO16 6YD
    - Southampton General Hospital
エストニア
- - Tallinn、エストニア、13419
    - North Estonia Medical Centre
  - Tartu、エストニア、50106
    - Clinical Research Centre
オーストラリア
- New South Wales
  - Darlinghurst、New South Wales、オーストラリア、2010
    - St George Dermatology and Skin Cancer Centre
  - Kogarah、New South Wales、オーストラリア、2217
    - Premier Specialists
- Victoria
  - Box Hill、Victoria、オーストラリア、3128
    - Box Hill Hospital
  - Carlton、Victoria、オーストラリア、3053
    - Skin Health Institute
  - East Melbourne、Victoria、オーストラリア、3002
    - Sinclair Dermatology
  - Melbourne、Victoria、オーストラリア、3004
    - The Alfred Hospital
  - Parkville、Victoria、オーストラリア、3050
    - The Royal Melbourne Hospital
カナダ
- Alberta
  - Calgary、Alberta、カナダ、T3E 0B2
    - Beacon Dermatology
- British Columbia
  - Surrey、British Columbia、カナダ、V3R 6A7
    - Doctor Chih-Ho Hong Medical Incorporated
- Ontario
  - Etobicoke、Ontario、カナダ、M8X 1Y9
    - Kingsway Clinical Research
  - Markham、Ontario、カナダ、L3P 1X3
    - Lynderm Research Inc
  - Oakville、Ontario、カナダ、L6J 7W5
    - The Centre for Clinical Trials Inc
  - Peterborough、Ontario、カナダ、K9J 5K2
    - SKiN Centre for Dermatology
  - Richmond Hill、Ontario、カナダ、L4B 1A5
    - The Centre for Dermatology
  - Toronto、Ontario、カナダ、M4W 2N4
    - Research Toronto
  - Windsor、Ontario、カナダ、N8T 1E6
    - XLR8 Medical Research, Incorporated
- Quebec
  - Québec、Quebec、カナダ、G1V 4X7
    - Centre de Recherche Dermatologique du Quebec metropolitain
  - Sherbrooke、Quebec、カナダ、J1G 1X9
    - Clinique Dermatologique de Sherbrooke
スウェーデン
- - Stockholm、スウェーデン、171 76
    - Karolinska Universitetssjukhuset Solna
スペイン
- - Madrid、スペイン、28034
    - Hospital Universitario Ramon y Cajal
  - Madrid、スペイン、28046
    - Hospital Universitario La Paz
  - Majadahonda、スペイン、28222
    - Hospital Universitario Puerta de Hierro Majadahonda
- Andalusia
  - Seville、Andalusia、スペイン、41009
    - Hospital Universitario Virgen Macarena
- Navarre
  - Pamplona、Navarre、スペイン、31008
    - Clinica Universidad de Navarra
- Valencia
  - Alicante、Valencia、スペイン、03010
    - Hospital General Universitario de Alicante
  - Manises、Valencia、スペイン、46940
    - Hospital de Manises
  - Valencia、Valencia、スペイン、46015
    - Hospital Arnau de Vilanova de Valencia
チェコ
- - Kutná Hora、チェコ、284 01
    - Kozni ambulance Kutna Hora sro
  - Nový Jičín、チェコ、741 01
    - Nemocnice Novy Jicin as
  - Pardubice、チェコ、530 02
    - CCR Czech as
  - Pilsen、チェコ、305 99
    - Fakultni Nemocnice Plzen
  - Prague、チェコ、130 00
    - CCR Prague sro
  - Prague、チェコ、120 00
    - Dermamedest sro
  - Prague、チェコ、106 00
    - Kozni ambulance Fialova sro
  - Prague、チェコ、150 00
    - Praglandia sro
  - Svitavy、チェコ、568 02
    - Dermatologicka ambulance MUDr Petr Trestik
デンマーク
- - Hellerup、デンマーク、2900
    - Gentofte Hospital
  - Odense、デンマーク、5000
    - Odense University Hospital
トルコ（Türkiye）
- - Ankara、トルコ（Türkiye）、06230
    - Hacettepe Universitesi Tip Fakultesi Hastanesi
  - Gaziantep、トルコ（Türkiye）、27310
    - Gaziantep Universitesi Tip Fakultesi Hastanesi
  - Istanbul、トルコ（Türkiye）、34093
    - Bezmialem Vakif Universitesi Hastanesi
  - Izmir、トルコ（Türkiye）、35620
    - Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
  - Kayseri、トルコ（Türkiye）、38030
    - Erciyes Universitesi Tip Fakultesi Hastanesi
  - Kocaeli、トルコ（Türkiye）、41380
    - Kocaeli Universitesi Tip Fakultesi Hastanesi
  - Sakarya、トルコ（Türkiye）、54050
    - Sakarya Egitim ve Arastirma Hastanesi
ドイツ
- - Bad Bentheim、ドイツ、48455
    - Fachklinik Bad Bentheim
  - Berlin、ドイツ、10247
    - Hautzentrum Friedrichshain - Dermatologie
  - Berlin、ドイツ、13672
    - Clinical Research Services Berlin GmbH
  - Halle、ドイツ、06120
    - Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
  - Hamburg、ドイツ、20354
    - Dermatologikum Hamburg
  - Kiel、ドイツ、24105
    - Universitaetsklinikum Schleswig-Holstein
  - Leipzig、ドイツ、04103
    - Velocity Clinical Research
  - Münster、ドイツ、48149
    - Universitaetsklinikum Muenster
  - Osnabrück、ドイツ、49074
    - KliFOs Klinische Forschung Osnabrueck
  - Remscheid、ドイツ、42897
    - Hautarztpraxis Mortazawi
  - Wuppertal、ドイツ、42283
    - Helios Klinikum Wuppertal
フィンランド
- - Helsinki、フィンランド、00180
    - CRST Helsinki
  - Helsinki、フィンランド、00180
    - CRST Turku
  - Oulu、フィンランド、90029
    - Oulun Yliopistollinen sairaala (OYS)
  - Tampere、フィンランド、33100
    - Terveystalo Tampere
ブラジル
- Paraná
  - Curitiba、Paraná、ブラジル、80030-110
    - CETI - Centro de Estudo em Terapias Inovadoras
- São Paulo
  - São Bernardo do Campo、São Paulo、ブラジル、09715-090
    - Centro Multidisciplinar de Estudos Clínicos - CEMEC
  - São José dos Campos、São Paulo、ブラジル、12243-280
    - ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
ベルギー
- - Brussels、ベルギー、1070
    - Hopital Erasme
  - Herstal、ベルギー、4040
    - Clinique Andre Renard
  - Maldegem、ベルギー、9990
    - Dermatologie Maldegem
ポルトガル
- - Almada、ポルトガル、2801-951
    - Hospital Garcia de Orta, EPE
  - Coimbra、ポルトガル、3000-075
    - Centro Hospitalar e Universitário de Coimbra, EPE
  - Lisbon、ポルトガル、1998-018
    - Hospital CUF Descobertas
  - Porto、ポルトガル、4099-001
    - Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
  - Porto、ポルトガル、4200-319
    - Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
ポーランド
- - Bialystok、ポーランド、15-879
    - ClinicMed Daniluk Nowak Spolka Komandytowa
  - Chorzów、ポーランド、41-500
    - Dermapolis Medical Dermatology Center dr n med Edyta Gebska
  - Gdansk、ポーランド、80-214
    - Uniwersyteckie Centrum Kliniczne
  - Krakow、ポーランド、31-530
    - Centermed krakow sp zoo
  - Lodz、ポーランド、90-349
    - AppleTreeClinics Network Spzoo
  - Lodz、ポーランド、90-338
    - Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
  - Lodz、ポーランド、91-495
    - Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
  - Lublin、ポーランド、20-078
    - Clinical Best Solutions Sp zoo Spolka komandytowa
  - Poznan、ポーランド、61-731
    - Clinical Research Center Spzoo Medic-R Spolka Komandytowa
  - Warsaw、ポーランド、02-625
    - Evimed sp zoo centrum medyczne evimed
メキシコ
- - Chihuahua City、メキシコ、31203
    - SCIENTIA Investigacion Clinica SC
  - Cuautitlán Izcalli、メキシコ、54750
    - Phylasis Clínicas Research S. De R. L. De C. V.
- Michoacán
  - Morelia、Michoacán、メキシコ、58249
    - Clinica de Enfermedades Cronicas y de Procedimientos Especiales
ルーマニア
- - Bucharest、ルーマニア、020125
    - Spitalul Clinic Colentina
南アフリカ
- - Durban、南アフリカ、3630
    - Hiway Medical Centre
- Gauteng
  - Centurion、Gauteng、南アフリカ、0157
    - Ryexo Clinical Research
  - Johannesburg、Gauteng、南アフリカ、2057
    - About Allergy
日本
- Chiba
  - Matsudo-shi、Chiba、日本、271-0092
    - Miyata Dermatology Clinic
  - Narita-shi、Chiba、日本、286-8520
    - International University of Health and Welfare Narita Hospital
- Hyōgo
  - Kobe、Hyōgo、日本、650-0017
    - Kobe University Hospital
- Kanagawa
  - Kawasaki-shi、Kanagawa、日本、216-8511
    - St Marianna University Hospital
  - Sagamihara-shi、Kanagawa、日本、252-0392
    - National Hospital Organization Sagamihara National Hospital
  - Yokohama、Kanagawa、日本、224-8503
    - Showa University Northern Yokohama Hospital
- Nagasaki
  - Nagasaki、Nagasaki、日本、852-8501
    - Nagasaki University Hospital
- Osaka
  - Habikino-shi、Osaka、日本、583-8588
    - Osaka Habikino Medical Center
  - Sakai-shi、Osaka、日本、593-8324
    - Dermatology and Ophthalmology Kume Clinic
- Shizuoka
  - Hamamatsu、Shizuoka、日本、431-3192
    - Hamamatsu University Hospital
- Tokyo
  - Minato-ku、Tokyo、日本、108-0014
    - Mita Dermatology Clinic
  - Shinagawa-ku、Tokyo、日本、142-8666
    - Showa University Hospital
  - Shinjuku-ku、Tokyo、日本、161-8521
    - Seibo International Catholic Hospital
  - Toshima-ku、Tokyo、日本、170-0002
    - Sugamo Kobayashi Derma Clinic
- Toyama
  - Takaoka-shi、Toyama、日本、933-0871
    - Shirasaki dermatology clinic
韓国
- - Ansansi, Gyeonggido、韓国、15355
    - Korea University Ansan Hospital
  - Bucheon-si, Gyeonggi-do、韓国、14584
    - Soon Chun Hyang University Bucheon Hospital
  - Busan、韓国、49241
    - Pusan National University Hospital
  - Daegu、韓国、41944
    - Kyungpook National University Hospital
  - Gwangju、韓国、61453
    - Chosun University Hospital
  - Incheon、韓国、22332
    - Inha University Hospital
  - Incheon、韓国、21431
    - The Catholic University of Korea Incheon St Marys Hospital
  - Seongnam-si, Gyeonggi-do、韓国、13620
    - Seoul National University Bundang Hospital
  - Seoul、韓国、03080
    - Seoul National University Hospital
  - Seoul、韓国、05505
    - Asan Medical Center
  - Seoul、韓国、03722
    - Severance Hospital, Yonsei University Health System
  - Seoul、韓国、05278
    - Kyung Hee University Hospital at Gangdong
  - Seoul、韓国、02841
    - Korea University Anam Hospital
  - Seoul、韓国、05030
    - Konkuk University Medical Center
  - Seoul、韓国、06973
    - Chung-Ang University Hospital
  - Seoul、韓国、07441
    - Hallym University Kangnam Sacred Heart Hospital
  - Seoul、韓国、04564
    - National Medical Center
  - Seoul、韓国、07804
    - Ewha Womans University Seoul Hospital
  - Seoul、韓国、06591
    - The Catholic Univ of Korea Seoul St Marys Hospital
  - Suwon-si, Gyeonggi-do、韓国、16499
    - Ajou University Hospital

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
- 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：ロカチンリマブロカチンリマブを 4 週間ごとに 1 回 (Q4W) 24 週間、2 週目に負荷用量で投与します。	薬：ロカチンリマブロカチンリマブは皮下（SC）注射で投与されます。他の名前： AMG 451 KHK4083
プラセボコンパレーター：プラセボプラセボ Q4W を 24 週間、2 週目に負荷用量を投与。	他の：プラセボ一致するプラセボは、SC 注射によって投与されます。

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 vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (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 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 ≥ 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 時間枠：Baseline and Week 24	AD skin pain was assessed 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 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
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 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 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 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
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 時間枠：Baseline and Week 16	AD skin pain was assessed 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
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
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24 時間枠：Baseline and Week 24	Weekly 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
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

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12月14日

一次修了 (実際)

2024年6月5日

研究の完了 (実際)

2024年8月27日

試験登録日

最初に提出

2022年12月7日

QC基準を満たした最初の提出物

2022年12月7日

最初の投稿 (実際)

2022年12月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月26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2日

最終確認日

2026年5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

20210143
2022-501538-44 (その他の識別子：EU CT Number)

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、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ると見なされます。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。

参加者グループ / アーム	介入・治療
実験的：ロカチンリマブロカチンリマブを 4 週間ごとに 1 回 (Q4W) 24 週間、2 週目に負荷用量で投与します。	薬：ロカチンリマブロカチンリマブは皮下（SC）注射で投与されます。他の名前： AMG 451 KHK4083
プラセボコンパレーター：プラセボプラセボ Q4W を 24 週間、2 週目に負荷用量を投与。	他の：プラセボ一致するプラセボは、SC 注射によって投与されます。

中等度から重度のアトピー性皮膚炎（AD）におけるロカチンリマブ（AMG 451）単剤療法を評価する第3相プラセボ対照二重盲検試験（ROCKET-Horizo​​n） (ROCKET-Horizon)

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、無作為化、24週間、プラセボ対照、二重盲検試験（ROCKET-地平線）

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

中等度から重度のアトピー性皮膚炎（AD）におけるロカチンリマブ（AMG 451）単剤療法を評価する第3相プラセボ対照二重盲検試験（ROCKET-Horizon） (ROCKET-Horizon)