Uno studio che valuta Rocatinlimab in combinazione con corticosteroidi topici e/o inibitori topici della calcineurina in partecipanti adulti con dermatite atopica da moderata a grave (AD) (ROCKET-SHUTTLE)
4 agosto 2026 aggiornato da: Amgen
Uno studio di fase 3, randomizzato, di 24 settimane, controllato con placebo, in doppio cieco per valutare l'efficacia, la sicurezza e la tollerabilità di rocatinlimab (AMG 451) in combinazione con corticosteroidi topici e/o inibitori topici della calcineurina in soggetti adulti con a grave dermatite atopica (AD) (ROCKET-SHUTTLE)
Gli obiettivi coprimari dello studio sono:
- Valutare l'efficacia di rocatinlimab in combinazione con corticosteroidi topici e/o inibitore topico della calcineurina (TCS/TCI), rispetto al placebo in combinazione con TCS/TCI alla settimana 24, valutata utilizzando il Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) .
- È stata valutata l'efficacia di rocatinlimab, in combinazione con TCS/TCI, rispetto al placebo in combinazione con TCS/TCI alla settimana 24, valutata utilizzando l'Eczema Area and Severity Index (EASI).
Panoramica dello studio
Stato
Stato
Completato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
Iscrizione
746
Fase
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: Amgen Call Center
- Numero di telefono: 866-572-6436
- Email: medinfo@amgen.com
Luoghi di studio
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
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La Plata, Buenos Aires, Argentina, B1902COS
- Framingham Centro Medico
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Ramos Mejía, Buenos Aires, Argentina, 1704
- DIM Clinica Privada
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Distrito Federal
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Buenos Aires, Distrito Federal, Argentina, 1121
- Fundacion CIDEA
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Buenos Aires, Distrito Federal, Argentina, 1054
- Buenos Aires Skin SA
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Buenos Aires, Distrito Federal, Argentina, 1414
- Care- Centro de Alergia y Enfermedades Respiratorias
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Buenos Aires, Distrito Federal, Argentina, 1425
- Psoriahue Medicina Interdisciplinaria SRL
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
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New South Wales
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Botany, New South Wales, Australia, 2019
- Emeritus Research Sydney
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital
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Queensland
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Benowa, Queensland, Australia, 4217
- The Skin Centre
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South Brisbane, Queensland, Australia, 4101
- Princess Alexandra Hospital
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Woolloongabba, Queensland, Australia, 4102
- Veracity Clinical Research
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Victoria
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Camberwell, Victoria, Australia, 3124
- Emeritus Research Melbourne
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Graz, Austria, 8036
- Medizinische Universitaet Graz
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Innsbruck, Austria, 6020
- Medizinische Universitaet Innsbruck
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Salzburg, Austria, 5020
- Landeskrankenhaus Salzburg
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Vienna, Austria, 1030
- Klinik Landstrasse
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Vienna, Austria, 1130
- Klinik Hietzing
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Bruges, Belgio, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
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Brussels, Belgio, 1090
- Universitair Ziekenhuis Brussel
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Brussels, Belgio, 1020
- Centre Hospitalier Universitaire Brugmann
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Brussels, Belgio, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Ghent, Belgio, 9000
- Universitair Ziekenhuis Gent
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Herstal, Belgio, 4040
- Clinique Andre Renard
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Kortrijk, Belgio, 8500
- Dermatologie Handelskaai
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Leuven, Belgio, 3000
- Universitaire Ziekenhuizen Leuven Gasthuisberg
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Liège, Belgio, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
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Loverval, Belgio, 6280
- Grand Hôpital de Charleroi
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Dupnitsa, Bulgaria, 2600
- Medical Center Asklepii OOD
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Pleven, Bulgaria, 5800
- Medical center Medconsult Pleven OOD
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Sofia, Bulgaria, 1407
- Medical Center Excelsior OOD
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Sofia, Bulgaria, 1431
- Diagnostic-Consultative Center Alexandrovska EOOD
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Sofia, Bulgaria, 1463
- Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
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Alberta
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Calgary, Alberta, Canada, T2J 7E1
- Dermatology Research Institute Incorporated
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Edmonton, Alberta, Canada, T5J 3S9
- Laser Rejuvenation Clinics Edmonton D T Incorporated
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Edmonton, Alberta, Canada, T6G 1C3
- Alberta Derma Surgery Centre
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British Columbia
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Surrey, British Columbia, Canada, V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg, Manitoba, Canada, R3M 3Z4
- Wiseman Dermatology Research Incorporated
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Ontario
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Coburg, Ontario, Canada, K9A 4J9
- Skin Health
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London, Ontario, Canada, N6A 2C2
- Centricity Research London
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Newmarket, Ontario, Canada, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
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Niagara Falls, Ontario, Canada, L2H 1H5
- Allergy Research Canada Incorporated
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North Bay, Ontario, Canada, P1B 3Z7
- North Bay Dermatology Centre
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Ottawa, Ontario, Canada, K2C 3N2
- Dermatology Ottawa Research Centre
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Ottawa, Ontario, Canada, K2C 3N2
- JRB Research Incorporated
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Richmond Hill, Ontario, Canada, L4B 1A5
- The Centre for Dermatology
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Toronto, Ontario, Canada, M2N 3A6
- North York Research Incorporated
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Toronto, Ontario, Canada, M3H 5Y8
- Toronto Research Centre Inc
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Waterloo, Ontario, Canada, N2J 1C4
- Alliance Clinical Trials
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Quebec
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Montreal, Quebec, Canada, H2X 2V1
- Innovaderm Research Inc
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Montreal, Quebec, Canada, H1Y 3L1
- Clinique de Dermatologie Rosemont
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Québec, Quebec, Canada, G1W 4R4
- Centre de Recherche Saint-Louis
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Québec, Quebec, Canada, G1V 4T3
- Diex Recherche Québec
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7T 0G3
- Saskatoon Dermatology Centre
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Beijing, Cina, 100044
- Peking University Peoples Hospital
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Shanghai, Cina, 200443
- Shanghai Skin Disease Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, Cina, 100050
- Beijing Friendship hospital, Capital Medical University
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Fujian
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Fuzhou, Fujian, Cina, 350000
- The First Affiliated Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, Cina, 510091
- Dermatology Hospital of Southern Medical University
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Guangzhou, Guangdong, Cina, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
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Guangzhou, Guangdong, Cina, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
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Shantou, Guangdong, Cina, 515041
- The Fist Affiliated Hospital of Shantou University Medical College
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Shenzhen, Guangdong, Cina, 518101
- Shenzhen Qianhai Shekou Free Trade Zone Hospital
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Henan
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Nanyang, Henan, Cina, 473002
- Nanyang First Peoples Hospital
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Hubei
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Wuhan, Hubei, Cina, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Jiangsu
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Wuxi, Jiangsu, Cina, 214001
- Wuxi Second Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, Cina, 330000
- Dermatology Hospital of Jiangxi Province
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Jilin
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Changchun, Jilin, Cina, 130021
- The First Hospital of Jilin University
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Sichuan
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Chengdu, Sichuan, Cina, 610017
- Chengdu Second Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Cina, 310016
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Cina, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
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Ningbo, Zhejiang, Cina, 315010
- The First Affiliation Hospital Of Ningbo University
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Taizhou, Zhejiang, Cina, 318000
- Taizhou Central Hospital
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Antony, Francia, 92160
- Hopital Prive d Antony
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Bordeaux, Francia, Cedex
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
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Brest, Francia, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
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Lille, Francia, 59037
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
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Lorient, Francia, 56322
- Centre Hospitalier de Bretagne Sud - Hopital du Scorff
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Marseille, Francia, 13385
- Hôpital La Timone
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Martigues, Francia, 13500
- Cabinet du Docteur Ruer-Mulard Mireille
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Nantes, Francia, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
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Nice, Francia, 06202
- Centre Hospitalier Universitaire Archet 2
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Paris, Francia, 75020
- Hôpital Tenon
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Paris, Francia, 75475
- Hopital Saint Louis
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Paris, Francia, 75018
- Hopital Bichat Claude Bernard
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Reims, Francia, 51100
- Polyclinique de Courlancy
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Rennes, Francia, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Rouen, Francia, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
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Saint-Priest-en-Jarez, Francia, 42270
- Centre Hospitalier Universitaire Saint Etienne Hopital Nord
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Toulon, Francia, 83800
- Hopital d instruction des armees sainte anne
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Frankfurt am Main, Germania, 60590
- Universitaetsklinikum Frankfurt
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Göttingen, Germania, 37075
- Universitaetsmedizin Goettingen - Georg-August-Universitaet
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Hamburg, Germania, 22391
- MensingDerma Research GmbH
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Hamburg, Germania, 20537
- TFS Trial Form Support GmbH
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Hanover, Germania, 30625
- Medizinische Hochschule Hannover
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Hanover, Germania, 30159
- Hautaerzte Zentrum Hannover
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Mainz, Germania, 55101
- Universitaetsmedizin Mainz
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Memmingen, Germania, 87700
- Beldio Research Gmbh
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Merzing, Germania, 66663
- Hautmedizin Saar
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München, Germania, 80802
- Klinikum rechts der Isar der TUM
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Aichi-ken
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Nagoya, Aichi-ken, Giappone, 454-0803
- Fukui Dermatology Clinic
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Fukuoka
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Fukuoka, Fukuoka, Giappone, 812-0013
- Ekihigashi Dermatology Allergy Clinic
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Hokkaido
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Obihiro-shi, Hokkaido, Giappone, 080-0013
- Takagi Dermatological Clinic Branch
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Sapporo, Hokkaido, Giappone, 060-0063
- Medical Corporation Kojinkai Sapporo Skin Clinic
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Giappone, 890-0063
- Katahira Dermatology Urology Clinic
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Kanagawa
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Kawasaki-shi, Kanagawa, Giappone, 211-0063
- Kosugi Dermatology Clinic
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Yokohama, Kanagawa, Giappone, 221-0825
- Nomura Dermatology Clinic
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Kumamoto
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Kumamoto, Kumamoto, Giappone, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
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Kumamoto, Kumamoto, Giappone, 862-0950
- Suizenji Dermatology Clinic
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Osaka
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Neyagawa, Osaka, Giappone, 572-0838
- Yoshioka Dermatology Clinic
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Shizuoka
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Hamamatsu, Shizuoka, Giappone, 430-0929
- JA Shizuoka Kohseiren Enshu Hospital
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Tokyo
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Adachi-ku, Tokyo, Giappone, 120-0034
- Mildix Skin Clinic
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Setagaya-ku, Tokyo, Giappone, 158-0097
- Naoko Dermatology Clinic
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Shinagawa-ku, Tokyo, Giappone, 141-8625
- NTT Medical Center Tokyo
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Shinjuku-ku, Tokyo, Giappone, 169-0075
- Yamate Dermatology Clinic
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Athens, Grecia, 11525
- 401 General Military Hospital Of Athens
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Athens, Grecia, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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Heraklion, Grecia, 71500
- University General Hospital of Heraklion
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Nea Ionia, Grecia, 14233
- General Hospital Of Nea Ionia Konstantopouleio Patision
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Piraeus, Grecia, 18536
- Geniko Nosokomeio Peiraia Tzaneio
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Thessaloniki, Grecia, 54642
- Ippokratio General Hospital of Thessaloniki
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Genova, Italia, 16132
- Ospedale Policlinico San Martino IRCCS
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LAquila, Italia, 67100
- Ospedale San Salvatore
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Roma, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Rozzano MI, Italia, 20089
- IRCCS Istituto Clinico Humanitas
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Johor
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Johor Bahru, Johor, Malaysia, 81100
- Hospital Sultan Ismail
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
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Perak
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Ipoh, Perak, Malaysia, 30450
- Hospital Raja Permaisuri Bainun
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Pulau Pinang
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George Town, Pulau Pinang, Malaysia, 10990
- Hospital Pulau Pinang
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Sabah
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Kota Kinabalu, Sabah, Malaysia, 88586
- Queen Elizabeth Hospital
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Bergen op Zoom, Olanda, 4624 VT
- Bravis Ziekenhuis
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Groningen, Olanda, 9700 RB
- Universitair Medisch Centrum Groningen
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Utrecht, Olanda, 3584 CX
- Universitair Medisch Centrum Utrecht
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Chorzów, Polonia, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
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Katowice, Polonia, 40-600
- GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
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Krakow, Polonia, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
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Lodz, Polonia, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Polonia, 90-752
- Ip Clinic Sp zoo
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Szczecin, Polonia, 71-500
- Twoja Przychodnia SCM
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Wroclaw, Polonia, 51-503
- DermMedica Spzoo Centrum Columbus
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Caguas, Porto Rico, 00727-9507
- Doctor Samuel Sanchez PSC
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Bath, Regno Unito, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
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Dudley, Regno Unito, DY1 2HQ
- Russells Hall Hospital
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Isleworth, Regno Unito, TW7 6AF
- West Middlesex University Hospital
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London, Regno Unito, NW3 2PF
- The Royal Free Hospital
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Salford, Regno Unito, M6 8HD
- Salford Care Organisation
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Shipley, Regno Unito, BD18 3SA
- Accellacare Yorkshire
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Brasov, Romania, 500112
- Theramed Healthcare SRL
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Cluj-Napoca, Romania, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
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Târgu Mureş, Romania, 540613
- Spitalul Clinic Judetean Mures
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Singapore, Singapore, 308205
- National Skin Centre
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Singapore, Singapore, 168753
- Singapore General Hospital
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Singapore, Singapore, 117599
- National University Hospital
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Bardejov, Slovacchia, 085 01
- Maxderm, sro
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Bratislava, Slovacchia, 813 69
- Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
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Prešov, Slovacchia, 081 81
- Fakultna nemocnica s poliklinikou JA Reimana Presov
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Svidník, Slovacchia, 089 01
- Sanare spol sro
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Ljubljana, Slovenia, 1000
- Univerzitetni klinicni center Ljubljana
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Maribor, Slovenia, 2000
- Univerzitetni Klinicni Center Maribor
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Madrid, Spagna, 28041
- Hospital Universitario 12 de Octubre
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Pontevedra, Spagna, 36001
- Complexo Hospitalario Universitario de Pontevedra
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Basque Country
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Bilbao, Basque Country, Spagna, 48013
- Hospital Universitario Basurto
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Catalonia
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Barcelona, Catalonia, Spagna, 08036
- Hospital Clinic i Provincial de Barcelona
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Valencia
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Valencia, Valencia, Spagna, 46014
- Hospital General Universitario de Valencia
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- The University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006
- Medical Dermatology Specialists
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Phoenix, Arizona, Stati Uniti, 85018
- Southwest Skin Specialists
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Sun City West, Arizona, Stati Uniti, 85375
- US Dermatology Partners Sun City West
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Arkansas
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North Little Rock, Arkansas, Stati Uniti, 72117
- Arkansas Research Trials, LLC
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California
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Bakersfield, California, Stati Uniti, 93301
- Kern Research Inc
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Los Angeles, California, Stati Uniti, 90056
- Wallace Medical Group Inc
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Los Angeles, California, Stati Uniti, 90033
- Keck Medicine of University of Southern California
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Palmdale, California, Stati Uniti, 93551
- Antelope Valley Clinical Trials
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Sacramento, California, Stati Uniti, 95816
- University of California at Davis Medical Center
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Sacramento, California, Stati Uniti, 95823
- Kaiser Permanente South Sacramento Medical Center
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San Diego, California, Stati Uniti, 92120
- Acclaim Clinical Research
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San Francisco, California, Stati Uniti, 94132
- Synergy Dermatology
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San Francisco, California, Stati Uniti, 94118
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Stati Uniti, 94118
- Kaiser Permanente Medical Center - San Francisco
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Florida
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Tampa, Florida, Stati Uniti, 33609
- TrueBlue Clinical Research
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Tampa, Florida, Stati Uniti, 33615
- Olympian Clinical Research - Tampa
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Georgia
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Alpharetta, Georgia, Stati Uniti, 30022
- Atlanta Dermatology, Vein and Research Center, PC
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Atlanta, Georgia, Stati Uniti, 30315
- Divine Dermatology and Aesthetics
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Illinois
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Skokie, Illinois, Stati Uniti, 60077
- Northshore University Healthsystem
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Indiana
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Clarksville, Indiana, Stati Uniti, 47129
- DS Research
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Indianapolis, Indiana, Stati Uniti, 46250
- Dawes Fretzin Clinical Research Group, LLC
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Kansas
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Leawood, Kansas, Stati Uniti, 66211
- Dermatology and Skin Cancer Center Leawood
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Louisiana
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Monroe, Louisiana, Stati Uniti, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
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Maryland
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Rockville, Maryland, Stati Uniti, 20850
- Aesthetic and Dermatology Center
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan Medical Center
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Auburn Hills, Michigan, Stati Uniti, 48326
- Oakland Hills Dermatology
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Nebraska
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Lincoln, Nebraska, Stati Uniti, 68505
- Somnos Clinical Research
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Omaha, Nebraska, Stati Uniti, 68144
- Skin Specialists PC
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89119
- Vivida Dermatology
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North Las Vegas, Nevada, Stati Uniti, 89030
- Las Vegas Clinical Trials
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New Jersey
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Hackensack, New Jersey, Stati Uniti, 07601
- Schweiger Dermatology Group, PC Research Division
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87102
- Albuquerque Clinical Trials Incorporated
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New York
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The Bronx, New York, Stati Uniti, 10455
- CHEAR Center LLC
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North Carolina
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Wilmington, North Carolina, Stati Uniti, 28401
- Accellacare of Wilmington
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Ohio
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Bexley, Ohio, Stati Uniti, 43209
- Bexley Dermatology Research
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Oregon
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Medford, Oregon, Stati Uniti, 97504
- Velocity Clinical Research Inc
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19103
- Paddington Testing Company Inc
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- University of Pittsburgh Medical Center
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South Dakota
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Rapid City, South Dakota, Stati Uniti, 57702
- Health Concepts
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Texas
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Austin, Texas, Stati Uniti, 78759
- US Dermatology Partners Jollyville
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El Paso, Texas, Stati Uniti, 79925
- Newco 3A Research LLC
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Kerrville, Texas, Stati Uniti, 78028
- Sante Clinical Research
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Plano, Texas, Stati Uniti, 75025
- Texas Dermatology Research Center
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Virginia
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Norfolk, Virginia, Stati Uniti, 23502
- Virginia Dermatology and Skin Cancer Center
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Bern, Svizzera, 3010
- Inselspital Bern
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Geneva, Svizzera, 1211
- Hopitaux Universitaires de Geneve
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Lausanne, Svizzera, 1011
- Centre Hospitalier Universitaire Vaudois
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Sankt Gallen, Svizzera, 9007
- Kantonsspital Sankt Gallen
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Zurich, Svizzera, 8091
- Universitaetsspital Zuerich
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Ankara, Turchia (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
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Istanbul, Turchia (Türkiye), 34390
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
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Istanbul, Turchia (Türkiye), 34662
- Acibadem Altunizade Hastanesi
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Istanbul, Turchia (Türkiye), 34899
- Marmara Universitesi Tip Fakultesi Hastanesi
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Samsun, Turchia (Türkiye), 55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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Budapest, Ungheria, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, Ungheria, 1027
- Csalogany Orvosi Kozpont
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Budapest, Ungheria, 1033
- Clinexpert Kft
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Békéscsaba, Ungheria, 5600
- Trial Pharma Kft
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Debrecen, Ungheria, 4032
- Debreceni Egyetem Klinikai Kozpont
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Gyöngyös, Ungheria, 3200
- Gyongyosi Bugat Pal Korhaz
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Kaposvár, Ungheria, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Orosháza, Ungheria, 5900
- DermaMed Research Kft
-
Szolnok, Ungheria, 5000
- Allergo-Derm Bakos Kft
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Zalaegerszeg, Ungheria, 8900
- Obudai Egeszsegugyi Centrum Kft
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 100 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- Età ≥ 18 anni con diagnosi di AD secondo i criteri di consenso AAD (American Academy of Dermatology) (2014) presente da almeno 6 mesi
- Storia di risposta inadeguata a TCS di potenza media o superiore entro 6 mesi (con o senza TCI)
- Punteggio EASI ≥16
- Punteggio vIGA-AD ≥3
- ≥10% della superficie corporea (BSA) del coinvolgimento di AD
- Scala di valutazione numerica del prurito peggiore ≥ 4
Criteri di esclusione:
- Trattamento con un prodotto biologico entro 12 settimane o 5 emivite, a seconda di quale sia più lunga, prima del Giorno 1
Trattamento con uno qualsiasi dei seguenti farmaci o terapie entro 4 settimane o 5 emivite, qualunque sia il più lungo, prima del Giorno 1:
- Corticosteroidi sistemici
- Immunosoppressori sistemici
- Fototerapia
- Inibitori della Janus chinasi
Trattamento con uno qualsiasi dei seguenti farmaci o terapie entro 1 settimana, prima del Giorno 1:
- TCS
- TCI
- Agenti antiprurito
- Inibitori topici della fosfodiesterasi di tipo 4
- Altri agenti immunosoppressori topici
- Combinazione di agenti topici inclusi TCS di qualsiasi potenza o TCI, inibitori della PDE4 o altri agenti immunosoppressori topici
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Doppio
Numero di armi
3
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Rocatinlimab Dose 1 + TCS/TCI
Rocatinlimab Dose 1 ogni 4 settimane (Q4W) per 24 settimane + TCS/TCI + dose di carico alla Settimana 2.
|
Iniezione sottocutanea (SC).
Altri nomi:
|
|
Sperimentale: Rocatinlimab Dose 2 + TCS/TCI
Rocatinlimab Dose 2 Q4W per 24 settimane + TCS/TCI + dose di carico alla Settimana 2.
|
Iniezione sottocutanea (SC).
Altri nomi:
|
|
Comparatore placebo: Placebo + TCS/TCI
Placebo Q4W per 24 settimane + TCS/TCI + dose di carico alla settimana 2.
|
Iniezione SC
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: MD, Amgen
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
21 febbraio 2023
Completamento primario (Effettivo)
Completamento primario
15 settembre 2024
Completamento dello studio (Effettivo)
Completamento dello studio
4 dicembre 2024
Date di iscrizione allo studio
Primo inviato
Primo inviato
2 febbraio 2023
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
2 febbraio 2023
Primo Inserito (Effettivo)
Primo Inserito
13 febbraio 2023
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
6 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 agosto 2026
Ultimo verificato
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie genetiche, congenite
- Malattie del sistema immunitario
- Ipersensibilità, immediata
- Ipersensibilità
- Malattie della pelle
- Malattie della pelle, genetiche
- Malattie della pelle, eczematose
- Dermatite
- Malattie e anomalie congenite, ereditarie e neonatali
- Malattie della pelle e del tessuto connettivo
- Dermatite, atopica
- Eczema
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 20210144
- 2022-501585-22-00 (Identificatore di registro: CTIS (EU))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Dati dei singoli pazienti anonimizzati per le variabili necessarie per affrontare la domanda di ricerca specifica in una richiesta di condivisione dei dati approvata.
Periodo di condivisione IPD
Le richieste di condivisione dei dati relative a questo studio saranno prese in considerazione a partire da 18 mesi dopo la conclusione dello studio e se 1) il prodotto e l'indicazione hanno ottenuto l'autorizzazione all'immissione in commercio sia negli Stati Uniti che in Europa o 2) lo sviluppo clinico per il prodotto e/o l'indicazione è interrotto e i dati non saranno presentati alle autorità di regolamentazione.
Non esiste una data di fine per l'idoneità a inviare una richiesta di condivisione dei dati per questo studio.
Criteri di accesso alla condivisione IPD
I ricercatori qualificati possono presentare una richiesta contenente gli obiettivi della ricerca, il/i prodotto/i Amgen e lo/gli studio/studi Amgen nell'ambito, gli endpoint/i risultati di interesse, il piano di analisi statistica, i requisiti in materia di dati, il piano di pubblicazione e le qualifiche del/i ricercatore/i.
In generale, Amgen non soddisfa le richieste esterne di dati dei singoli pazienti allo scopo di rivalutare i problemi di sicurezza ed efficacia già affrontati nell'etichettatura del prodotto.
Le richieste vengono esaminate da un comitato di consulenti interni.
In caso di mancata approvazione, un comitato di revisione indipendente sulla condivisione dei dati arbitrerà e prenderà la decisione finale.
Dopo l'approvazione, le informazioni necessarie per affrontare la domanda di ricerca saranno fornite secondo i termini di un accordo di condivisione dei dati.
Ciò può includere dati anonimizzati di singoli pazienti e/o documenti di supporto disponibili, contenenti frammenti di codice di analisi ove previsto nelle specifiche di analisi.
Ulteriori dettagli sono disponibili all'URL sottostante.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .