Исследование по оценке применения Рокатинлимаба в комбинации с топическими кортикостероидами и/или топическими ингибиторами кальциневрина у взрослых участников с атопическим дерматитом от умеренной до тяжелой степени (АД) (ROCKET-SHUTTLE)
4 августа 2026 г. обновлено: Amgen
Фаза 3, рандомизированное, 24-недельное, плацебо-контролируемое, двойное слепое исследование для оценки эффективности, безопасности и переносимости рокатинлимаба (AMG 451) в комбинации с топическими кортикостероидами и/или топическими ингибиторами кальциневрина у взрослых субъектов с умеренным до тяжелого атопического дерматита (АД) (ROCKET-SHUTTLE)
Второстепенными задачами исследования являются:
- Оценить эффективность рокатинлимаба в комбинации с кортикостероидом для местного применения и/или ингибитором кальциневрина для местного применения (TCS/TCI) по сравнению с плацебо в комбинации с TCS/TCI на 24-й неделе, оцененную с использованием глобальной оценки атопического дерматита утвержденного исследователя (vIGA-AD). .
- Для оценки эффективности рокатинлимаба в комбинации с ТКС/ТХИ по сравнению с плацебо в комбинации с ТХС/ТХИ на 24-й неделе, оцененной с использованием индекса площади и тяжести экземы (EASI).
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
746
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
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New South Wales
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Botany, New South Wales, Австралия, 2019
- Emeritus Research Sydney
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Westmead, New South Wales, Австралия, 2145
- Westmead Hospital
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Queensland
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Benowa, Queensland, Австралия, 4217
- The Skin Centre
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South Brisbane, Queensland, Австралия, 4101
- Princess Alexandra Hospital
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Woolloongabba, Queensland, Австралия, 4102
- Veracity Clinical Research
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Victoria
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Camberwell, Victoria, Австралия, 3124
- Emeritus Research Melbourne
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Graz, Австрия, 8036
- Medizinische Universitaet Graz
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Innsbruck, Австрия, 6020
- Medizinische Universitaet Innsbruck
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Salzburg, Австрия, 5020
- Landeskrankenhaus Salzburg
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Vienna, Австрия, 1030
- Klinik Landstrasse
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Vienna, Австрия, 1130
- Klinik Hietzing
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Buenos Aires
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CABA, Buenos Aires, Аргентина, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
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La Plata, Buenos Aires, Аргентина, B1902COS
- Framingham Centro Medico
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Ramos Mejía, Buenos Aires, Аргентина, 1704
- DIM Clinica Privada
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Distrito Federal
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Buenos Aires, Distrito Federal, Аргентина, 1121
- Fundacion CIDEA
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Buenos Aires, Distrito Federal, Аргентина, 1054
- Buenos Aires Skin SA
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Buenos Aires, Distrito Federal, Аргентина, 1414
- Care- Centro de Alergia y Enfermedades Respiratorias
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Buenos Aires, Distrito Federal, Аргентина, 1425
- Psoriahue Medicina Interdisciplinaria SRL
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Santa Fe Province
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Rosario, Santa Fe Province, Аргентина, 2000
- Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
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Bruges, Бельгия, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
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Brussels, Бельгия, 1090
- Universitair Ziekenhuis Brussel
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Brussels, Бельгия, 1020
- Centre Hospitalier Universitaire Brugmann
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Brussels, Бельгия, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Ghent, Бельгия, 9000
- Universitair Ziekenhuis Gent
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Herstal, Бельгия, 4040
- Clinique Andre Renard
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Kortrijk, Бельгия, 8500
- Dermatologie Handelskaai
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Leuven, Бельгия, 3000
- Universitaire Ziekenhuizen Leuven Gasthuisberg
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Liège, Бельгия, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
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Loverval, Бельгия, 6280
- Grand Hôpital de Charleroi
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Dupnitsa, Болгария, 2600
- Medical Center Asklepii OOD
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Pleven, Болгария, 5800
- Medical center Medconsult Pleven OOD
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Sofia, Болгария, 1407
- Medical Center Excelsior OOD
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Sofia, Болгария, 1431
- Diagnostic-Consultative Center Alexandrovska EOOD
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Sofia, Болгария, 1463
- Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
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Budapest, Венгрия, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, Венгрия, 1027
- Csalogany Orvosi Kozpont
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Budapest, Венгрия, 1033
- Clinexpert Kft
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Békéscsaba, Венгрия, 5600
- Trial Pharma Kft
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Debrecen, Венгрия, 4032
- Debreceni Egyetem Klinikai Kozpont
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Gyöngyös, Венгрия, 3200
- Gyongyosi Bugat Pal Korhaz
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Kaposvár, Венгрия, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Orosháza, Венгрия, 5900
- DermaMed Research Kft
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Szolnok, Венгрия, 5000
- Allergo-Derm Bakos Kft
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Zalaegerszeg, Венгрия, 8900
- Obudai Egeszsegugyi Centrum Kft
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Frankfurt am Main, Германия, 60590
- Universitaetsklinikum Frankfurt
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Göttingen, Германия, 37075
- Universitaetsmedizin Goettingen - Georg-August-Universitaet
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Hamburg, Германия, 22391
- MensingDerma Research GmbH
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Hamburg, Германия, 20537
- TFS Trial Form Support GmbH
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Hanover, Германия, 30625
- Medizinische Hochschule Hannover
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Hanover, Германия, 30159
- Hautaerzte Zentrum Hannover
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Mainz, Германия, 55101
- Universitaetsmedizin Mainz
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Memmingen, Германия, 87700
- Beldio Research Gmbh
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Merzing, Германия, 66663
- Hautmedizin Saar
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München, Германия, 80802
- Klinikum rechts der Isar der TUM
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Athens, Греция, 11525
- 401 General Military Hospital Of Athens
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Athens, Греция, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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Heraklion, Греция, 71500
- University General Hospital of Heraklion
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Nea Ionia, Греция, 14233
- General Hospital Of Nea Ionia Konstantopouleio Patision
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Piraeus, Греция, 18536
- Geniko Nosokomeio Peiraia Tzaneio
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Thessaloniki, Греция, 54642
- Ippokratio General Hospital of Thessaloniki
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Madrid, Испания, 28041
- Hospital Universitario 12 de Octubre
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Pontevedra, Испания, 36001
- Complexo Hospitalario Universitario de Pontevedra
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Basque Country
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Bilbao, Basque Country, Испания, 48013
- Hospital Universitario Basurto
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Catalonia
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Barcelona, Catalonia, Испания, 08036
- Hospital Clinic i Provincial de Barcelona
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Valencia
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Valencia, Valencia, Испания, 46014
- Hospital General Universitario de Valencia
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Genova, Италия, 16132
- Ospedale Policlinico San Martino IRCCS
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LAquila, Италия, 67100
- Ospedale San Salvatore
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Roma, Италия, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Rozzano MI, Италия, 20089
- IRCCS Istituto Clinico Humanitas
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Alberta
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Calgary, Alberta, Канада, T2J 7E1
- Dermatology Research Institute Incorporated
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Edmonton, Alberta, Канада, T5J 3S9
- Laser Rejuvenation Clinics Edmonton D T Incorporated
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Edmonton, Alberta, Канада, T6G 1C3
- Alberta Derma Surgery Centre
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British Columbia
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Surrey, British Columbia, Канада, V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg, Manitoba, Канада, R3M 3Z4
- Wiseman Dermatology Research Incorporated
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Ontario
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Coburg, Ontario, Канада, K9A 4J9
- Skin Health
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London, Ontario, Канада, N6A 2C2
- Centricity Research London
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Newmarket, Ontario, Канада, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
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Niagara Falls, Ontario, Канада, L2H 1H5
- Allergy Research Canada Incorporated
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North Bay, Ontario, Канада, P1B 3Z7
- North Bay Dermatology Centre
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Ottawa, Ontario, Канада, K2C 3N2
- Dermatology Ottawa Research Centre
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Ottawa, Ontario, Канада, K2C 3N2
- JRB Research Incorporated
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Richmond Hill, Ontario, Канада, L4B 1A5
- The Centre for Dermatology
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Toronto, Ontario, Канада, M2N 3A6
- North York Research Incorporated
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Toronto, Ontario, Канада, M3H 5Y8
- Toronto Research Centre Inc
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Waterloo, Ontario, Канада, N2J 1C4
- Alliance Clinical Trials
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Quebec
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Montreal, Quebec, Канада, H2X 2V1
- Innovaderm Research Inc
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Montreal, Quebec, Канада, H1Y 3L1
- Clinique de Dermatologie Rosemont
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Québec, Quebec, Канада, G1W 4R4
- Centre de Recherche Saint-Louis
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Québec, Quebec, Канада, G1V 4T3
- Diex Recherche Québec
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Saskatchewan
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Saskatoon, Saskatchewan, Канада, S7T 0G3
- Saskatoon Dermatology Centre
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Beijing, Китай, 100044
- Peking University Peoples Hospital
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Shanghai, Китай, 200443
- Shanghai Skin Disease Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Китай, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, Китай, 100050
- Beijing Friendship hospital, Capital Medical University
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Fujian
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Fuzhou, Fujian, Китай, 350000
- The First Affiliated Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, Китай, 510091
- Dermatology Hospital of Southern Medical University
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Guangzhou, Guangdong, Китай, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
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Guangzhou, Guangdong, Китай, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
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Shantou, Guangdong, Китай, 515041
- The Fist Affiliated Hospital of Shantou University Medical College
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Shenzhen, Guangdong, Китай, 518101
- Shenzhen Qianhai Shekou Free Trade Zone Hospital
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Henan
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Nanyang, Henan, Китай, 473002
- Nanyang First Peoples Hospital
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Hubei
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Wuhan, Hubei, Китай, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Jiangsu
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Wuxi, Jiangsu, Китай, 214001
- Wuxi Second Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, Китай, 330000
- Dermatology Hospital of Jiangxi Province
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Jilin
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Changchun, Jilin, Китай, 130021
- The First Hospital of Jilin University
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Sichuan
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Chengdu, Sichuan, Китай, 610017
- Chengdu Second Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Китай, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Китай, 310016
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Китай, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
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Ningbo, Zhejiang, Китай, 315010
- The First Affiliation Hospital Of Ningbo University
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Taizhou, Zhejiang, Китай, 318000
- Taizhou Central Hospital
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Johor
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Johor Bahru, Johor, Малайзия, 81100
- Hospital Sultan Ismail
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Малайзия, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Малайзия, 59100
- University Malaya Medical Centre
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Kuala Lumpur, Kuala Lumpur, Малайзия, 56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
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Perak
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Ipoh, Perak, Малайзия, 30450
- Hospital Raja Permaisuri Bainun
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Pulau Pinang
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George Town, Pulau Pinang, Малайзия, 10990
- Hospital Pulau Pinang
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Sabah
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Kota Kinabalu, Sabah, Малайзия, 88586
- Queen Elizabeth Hospital
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Bergen op Zoom, Нидерланды, 4624 VT
- Bravis Ziekenhuis
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Groningen, Нидерланды, 9700 RB
- Universitair Medisch Centrum Groningen
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Utrecht, Нидерланды, 3584 CX
- Universitair Medisch Centrum Utrecht
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Chorzów, Польша, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
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Katowice, Польша, 40-600
- GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
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Krakow, Польша, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
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Lodz, Польша, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Польша, 90-752
- Ip Clinic Sp zoo
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Szczecin, Польша, 71-500
- Twoja Przychodnia SCM
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Wroclaw, Польша, 51-503
- DermMedica Spzoo Centrum Columbus
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Caguas, Пуэрто-Рико, 00727-9507
- Doctor Samuel Sanchez PSC
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Brasov, Румыния, 500112
- Theramed Healthcare SRL
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Cluj-Napoca, Румыния, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
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Târgu Mureş, Румыния, 540613
- Spitalul Clinic Judetean Mures
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Singapore, Сингапур, 308205
- National Skin Centre
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Singapore, Сингапур, 168753
- Singapore General Hospital
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Singapore, Сингапур, 117599
- National University Hospital
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Bardejov, Словакия, 085 01
- Maxderm, sro
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Bratislava, Словакия, 813 69
- Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
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Prešov, Словакия, 081 81
- Fakultna nemocnica s poliklinikou JA Reimana Presov
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Svidník, Словакия, 089 01
- Sanare spol sro
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Ljubljana, Словения, 1000
- Univerzitetni klinicni center Ljubljana
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Maribor, Словения, 2000
- Univerzitetni Klinicni Center Maribor
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Bath, Соединенное Королевство, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
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Dudley, Соединенное Королевство, DY1 2HQ
- Russells Hall Hospital
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Isleworth, Соединенное Королевство, TW7 6AF
- West Middlesex University Hospital
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London, Соединенное Королевство, NW3 2PF
- The Royal Free Hospital
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Salford, Соединенное Королевство, M6 8HD
- Salford Care Organisation
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Shipley, Соединенное Королевство, BD18 3SA
- Accellacare Yorkshire
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Alabama
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Birmingham, Alabama, Соединенные Штаты, 35233
- The University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85006
- Medical Dermatology Specialists
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Phoenix, Arizona, Соединенные Штаты, 85018
- Southwest Skin Specialists
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Sun City West, Arizona, Соединенные Штаты, 85375
- US Dermatology Partners Sun City West
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Arkansas
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North Little Rock, Arkansas, Соединенные Штаты, 72117
- Arkansas Research Trials, LLC
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California
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Bakersfield, California, Соединенные Штаты, 93301
- Kern Research Inc
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Los Angeles, California, Соединенные Штаты, 90056
- Wallace Medical Group Inc
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Los Angeles, California, Соединенные Штаты, 90033
- Keck Medicine of University of Southern California
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Palmdale, California, Соединенные Штаты, 93551
- Antelope Valley Clinical Trials
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Sacramento, California, Соединенные Штаты, 95816
- University of California at Davis Medical Center
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Sacramento, California, Соединенные Штаты, 95823
- Kaiser Permanente South Sacramento Medical Center
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San Diego, California, Соединенные Штаты, 92120
- Acclaim Clinical Research
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San Francisco, California, Соединенные Штаты, 94132
- Synergy Dermatology
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San Francisco, California, Соединенные Штаты, 94118
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Соединенные Штаты, 94118
- Kaiser Permanente Medical Center - San Francisco
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Florida
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Tampa, Florida, Соединенные Штаты, 33609
- TrueBlue Clinical Research
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Tampa, Florida, Соединенные Штаты, 33615
- Olympian Clinical Research - Tampa
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Georgia
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Alpharetta, Georgia, Соединенные Штаты, 30022
- Atlanta Dermatology, Vein and Research Center, PC
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Atlanta, Georgia, Соединенные Штаты, 30315
- Divine Dermatology and Aesthetics
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Illinois
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Skokie, Illinois, Соединенные Штаты, 60077
- Northshore University Healthsystem
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Indiana
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Clarksville, Indiana, Соединенные Штаты, 47129
- DS Research
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Indianapolis, Indiana, Соединенные Штаты, 46250
- Dawes Fretzin Clinical Research Group, LLC
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Kansas
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Leawood, Kansas, Соединенные Штаты, 66211
- Dermatology and Skin Cancer Center Leawood
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Louisiana
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Monroe, Louisiana, Соединенные Штаты, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
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Maryland
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Rockville, Maryland, Соединенные Штаты, 20850
- Aesthetic and Dermatology Center
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48109
- University of Michigan Medical Center
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Auburn Hills, Michigan, Соединенные Штаты, 48326
- Oakland Hills Dermatology
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Nebraska
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Lincoln, Nebraska, Соединенные Штаты, 68505
- Somnos Clinical Research
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Omaha, Nebraska, Соединенные Штаты, 68144
- Skin Specialists PC
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Nevada
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Las Vegas, Nevada, Соединенные Штаты, 89119
- Vivida Dermatology
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North Las Vegas, Nevada, Соединенные Штаты, 89030
- Las Vegas Clinical Trials
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New Jersey
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Hackensack, New Jersey, Соединенные Штаты, 07601
- Schweiger Dermatology Group, PC Research Division
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New Mexico
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Albuquerque, New Mexico, Соединенные Штаты, 87102
- Albuquerque Clinical Trials Incorporated
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New York
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The Bronx, New York, Соединенные Штаты, 10455
- CHEAR Center LLC
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North Carolina
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Wilmington, North Carolina, Соединенные Штаты, 28401
- Accellacare of Wilmington
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Ohio
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Bexley, Ohio, Соединенные Штаты, 43209
- Bexley Dermatology Research
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Oregon
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Medford, Oregon, Соединенные Штаты, 97504
- Velocity Clinical Research Inc
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19103
- Paddington Testing Company Inc
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
- University of Pittsburgh Medical Center
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South Dakota
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Rapid City, South Dakota, Соединенные Штаты, 57702
- Health Concepts
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Texas
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Austin, Texas, Соединенные Штаты, 78759
- US Dermatology Partners Jollyville
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El Paso, Texas, Соединенные Штаты, 79925
- Newco 3A Research LLC
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Kerrville, Texas, Соединенные Штаты, 78028
- Sante Clinical Research
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Plano, Texas, Соединенные Штаты, 75025
- Texas Dermatology Research Center
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Virginia
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Norfolk, Virginia, Соединенные Штаты, 23502
- Virginia Dermatology and Skin Cancer Center
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Ankara, Турция (Туркие), 06800
- Ankara Bilkent Sehir Hastanesi
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Istanbul, Турция (Туркие), 34390
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
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Istanbul, Турция (Туркие), 34662
- Acibadem Altunizade Hastanesi
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Istanbul, Турция (Туркие), 34899
- Marmara Universitesi Tip Fakultesi Hastanesi
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Samsun, Турция (Туркие), 55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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Antony, Франция, 92160
- Hopital Prive d Antony
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Bordeaux, Франция, Cedex
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
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Brest, Франция, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
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Lille, Франция, 59037
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
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Lorient, Франция, 56322
- Centre Hospitalier de Bretagne Sud - Hopital du Scorff
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Marseille, Франция, 13385
- Hôpital La Timone
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Martigues, Франция, 13500
- Cabinet du Docteur Ruer-Mulard Mireille
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Nantes, Франция, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
-
Nice, Франция, 06202
- Centre Hospitalier Universitaire Archet 2
-
Paris, Франция, 75020
- Hôpital Tenon
-
Paris, Франция, 75475
- Hopital Saint Louis
-
Paris, Франция, 75018
- Hopital Bichat Claude Bernard
-
Reims, Франция, 51100
- Polyclinique de Courlancy
-
Rennes, Франция, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
-
Rouen, Франция, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
-
Saint-Priest-en-Jarez, Франция, 42270
- Centre Hospitalier Universitaire Saint Etienne Hopital Nord
-
Toulon, Франция, 83800
- Hopital d instruction des armees sainte anne
-
-
-
-
-
Bern, Швейцария, 3010
- Inselspital Bern
-
Geneva, Швейцария, 1211
- Hopitaux Universitaires de Geneve
-
Lausanne, Швейцария, 1011
- Centre Hospitalier Universitaire Vaudois
-
Sankt Gallen, Швейцария, 9007
- Kantonsspital Sankt Gallen
-
Zurich, Швейцария, 8091
- Universitaetsspital Zuerich
-
-
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Япония, 454-0803
- Fukui Dermatology Clinic
-
-
Fukuoka
-
Fukuoka, Fukuoka, Япония, 812-0013
- Ekihigashi Dermatology Allergy Clinic
-
-
Hokkaido
-
Obihiro-shi, Hokkaido, Япония, 080-0013
- Takagi Dermatological Clinic Branch
-
Sapporo, Hokkaido, Япония, 060-0063
- Medical Corporation Kojinkai Sapporo Skin Clinic
-
-
Kagoshima-ken
-
Kagoshima, Kagoshima-ken, Япония, 890-0063
- Katahira Dermatology Urology Clinic
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, Япония, 211-0063
- Kosugi Dermatology Clinic
-
Yokohama, Kanagawa, Япония, 221-0825
- Nomura Dermatology Clinic
-
-
Kumamoto
-
Kumamoto, Kumamoto, Япония, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
-
Kumamoto, Kumamoto, Япония, 862-0950
- Suizenji Dermatology Clinic
-
-
Osaka
-
Neyagawa, Osaka, Япония, 572-0838
- Yoshioka Dermatology Clinic
-
-
Shizuoka
-
Hamamatsu, Shizuoka, Япония, 430-0929
- JA Shizuoka Kohseiren Enshu Hospital
-
-
Tokyo
-
Adachi-ku, Tokyo, Япония, 120-0034
- Mildix Skin Clinic
-
Setagaya-ku, Tokyo, Япония, 158-0097
- Naoko Dermatology Clinic
-
Shinagawa-ku, Tokyo, Япония, 141-8625
- NTT Medical Center Tokyo
-
Shinjuku-ku, Tokyo, Япония, 169-0075
- Yamate Dermatology Clinic
-
-
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 AD в соответствии с критериями консенсуса AAD (Американской академии дерматологии) (2014 г.) в течение не менее 6 месяцев.
- Неадекватная реакция на ТКС средней или высокой активности в анамнезе в течение 6 месяцев (с или без ТХИ)
- 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
- ОТК
- Противозудные средства
- Местные ингибиторы фосфодиэстеразы 4 типа
- Другие местные иммунодепрессанты
- Комбинированные препараты для местного применения, включая ТКС любой силы действия или ТХИ, ингибиторы ФДЭ4 или другие иммунодепрессанты для местного применения.
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: Последовательное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Рокатинлимаб доза 1 + TCS/TCI
Рокатинлимаб 1 доза каждые 4 недели (Q4W) в течение 24 недель + TCS/TCI + нагрузочная доза на 2-й неделе.
|
Подкожная (п/к) инъекция
Другие имена:
|
|
Экспериментальный: Рокатинлимаб, доза 2 + TCS/TCI
Рокатинлимаб, доза 2 каждые 4 недели в течение 24 недель + TCS/TCI + нагрузочная доза на 2-й неделе.
|
Подкожная (п/к) инъекция
Другие имена:
|
|
Плацебо Компаратор: Плацебо + TCS/TCI
Плацебо Q4W в течение 24 недель + TCS/TCI + нагрузочная доза на 2-й неделе.
|
П/к инъекция
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
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
|
|
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," participant met rIGA 0/1; if "No," they did not.
If vIGA-AD = 0, participant met rIGA 0/1.
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 vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (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 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
|
|
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 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
|
|
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 ≥ 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 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
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Временное ограничение: Baseline and Week 16
|
The worst pruritus score 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 score 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 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 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.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
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 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 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
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.
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)
21 февраля 2023 г.
Первичное завершение (Действительный)
15 сентября 2024 г.
Завершение исследования (Действительный)
4 декабря 2024 г.
Даты регистрации исследования
Первый отправленный
2 февраля 2023 г.
Впервые представлено, что соответствует критериям контроля качества
2 февраля 2023 г.
Первый опубликованный (Действительный)
13 февраля 2023 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
6 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
4 августа 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Генетические заболевания, врожденные
- Заболевания иммунной системы
- Гиперчувствительность, немедленная
- Гиперчувствительность
- Кожные заболевания
- Кожные заболевания, генетические
- Кожные заболевания, экзематозные
- Дерматит
- Врожденные, наследственные и неонатальные заболевания и аномалии
- Заболевания кожи и соединительной ткани
- Дерматит, атопический
- Экзема
Другие идентификационные номера исследования
- 20210144
- 2022-501585-22-00 (Идентификатор реестра: CTIS (EU))
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. .