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Исследование по оценке применения Рокатинлимаба при атопическом дерматите средней и тяжелой степени (ROCKET-IGNITE) (ROCKET-Ignite)

25 июня 2026 г. обновлено: Amgen

Фаза 3, 24-недельное, рандомизированное, плацебо-контролируемое, двойное слепое исследование для оценки эффективности, безопасности и переносимости монотерапии рокатинлимабом (AMG 451) у взрослых субъектов с атопическим дерматитом от умеренной до тяжелой степени (АД)

Целью данного исследования является оценка эффективности и безопасности рокатинлимаба при монотерапии.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

769

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 100 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Описание

Критерии включения:

  • Возраст ≥ 18 лет с диагнозом БА в соответствии с Консенсусными критериями БА (2014 г.) в течение не менее 6 месяцев.
  • История неадекватного ответа на ТКС (местные кортикостероиды) средней или высокой активности в течение 6 месяцев (с местными ингибиторами кальциневрина [TCI] или без них)
  • Оценка EASI ≥16
  • показатель vIGA-AD ≥3
  • ≥10% площади поверхности тела (ППТ) с поражением атопического дерматита
  • Числовая шкала оценки выраженного зуда ≥ 4

Критерий исключения:

  • Лечение биологическим препаратом в течение 12 недель или 5 периодов полувыведения, в зависимости от того, что дольше, до 1-го дня.

  • Лечение любым из следующих препаратов или методов лечения в течение 4 недель или 5 периодов полувыведения, в зависимости от того, что дольше, до 1-го дня:

    • Системные кортикостероиды
    • Системные иммунодепрессанты
    • Фототерапия
    • Ингибиторы янус-киназы

  • Лечение любым из следующих препаратов или методов лечения в течение 1 недели до 1-го дня:

    • ТКС любой потенции
    • ОТК
    • Противозудный препарат
    • Местные ингибиторы фосфодиэстеразы 4 типа
    • Другие местные иммунодепрессанты

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Рука А
Рокатинлимаб 1 доза каждые 4 недели (Q4W) + нагрузочная доза на 2-й неделе
Лекарство: Рокатинлимаб
Участники будут получать Рокатинлимаб подкожно.
Другие имена:
  • АМГ 451
Экспериментальный: Рука Б
Рокатинлимаб, доза 2 каждые 4 недели + нагрузочная доза на 2-й неделе
Лекарство: Рокатинлимаб
Участники будут получать Рокатинлимаб подкожно.
Другие имена:
  • АМГ 451
Плацебо Компаратор: Рука С
Плацебо Q4W+ нагрузочная доза на 2 неделе
Лекарство: Плацебо
Участники будут получать плацебо подкожно.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants Who Achieved EASI 75 at Week 16
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Amgen

Следователи

  • Директор по исследованиям: MD, Amgen

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

31 мая 2022 г.

Первичное завершение (Действительный)

28 ноября 2024 г.

Завершение исследования (Действительный)

13 января 2025 г.

Даты регистрации исследования

Первый отправленный

24 мая 2022 г.

Впервые представлено, что соответствует критериям контроля качества

31 мая 2022 г.

Первый опубликованный (Действительный)

1 июня 2022 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

23 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

25 июня 2026 г.

Последняя проверка

1 февраля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 20210142
  • 2022-501540-15-00 (Ктис)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Деидентифицированные данные отдельных пациентов для переменных, необходимых для решения конкретного исследовательского вопроса в утвержденном запросе на обмен данными.

Сроки обмена IPD

Запросы на обмен данными, относящиеся к этому исследованию, будут рассматриваться через 18 месяцев после окончания исследования, и либо 1) продукт и показание получили регистрационное удостоверение как в США, так и в Европе, либо 2) клиническая разработка продукта и/или показания прекращена. данные не будут переданы в регулирующие органы. Нет даты окончания права на подачу запроса на обмен данными для этого исследования.

Критерии совместного доступа к IPD

Квалифицированные исследователи могут подать запрос, содержащий цели исследования, продукт(ы) Amgen и исследование/исследования Amgen по объему, интересующие конечные точки/результаты, план статистического анализа, требования к данным, план публикации и квалификацию исследователя(ей). Как правило, Amgen не предоставляет внешние запросы на предоставление данных об отдельных пациентах с целью переоценки вопросов безопасности и эффективности, уже отраженных в маркировке продукта. Запросы рассматриваются комитетом внутренних консультантов. Если решение не будет одобрено, независимая комиссия по обмену данными вынесет третейский суд и примет окончательное решение. После утверждения информация, необходимая для решения вопроса исследования, будет предоставлена ​​в соответствии с условиями соглашения об обмене данными. Это может включать анонимизированные данные отдельных пациентов и/или доступные подтверждающие документы, содержащие фрагменты кода анализа, если они указаны в спецификациях анализа. Более подробная информация доступна по URL-адресу ниже.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • МКФ
  • КСО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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