Een onderzoek waarin Rocatinlimab wordt beoordeeld in combinatie met lokale corticosteroïden en/of lokale calcineurineremmers bij volwassen deelnemers met matige tot ernstige atopische dermatitis (AD) (ROCKET-SHUTTLE)
4 augustus 2026 bijgewerkt door: Amgen
Een gerandomiseerde, 24 weken durende, placebogecontroleerde, dubbelblinde fase 3-studie ter beoordeling van de werkzaamheid, veiligheid en verdraagbaarheid van Rocatinlimab (AMG 451) in combinatie met lokale corticosteroïden en/of lokale calcineurineremmers bij volwassen proefpersonen met matige tot ernstige atopische dermatitis (AD) (ROCKET-SHUTTLE)
De coprimaire doelstellingen van de studie zijn:
- Ter evaluatie van de werkzaamheid van rocatinlimab in combinatie met topische corticosteroïden en/of topische calcineurineremmers (TCS/TCI), vergeleken met placebo in combinatie met TCS/TCI in week 24, beoordeeld met behulp van Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) .
- Om de werkzaamheid van rocatinlimab, in combinatie met TCS/TCI, te evalueren in vergelijking met placebo in combinatie met TCS/TCI in week 24, beoordeeld met behulp van Eczema Area and Severity Index (EASI).
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
746
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Buenos Aires
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CABA, Buenos Aires, Argentinië, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
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La Plata, Buenos Aires, Argentinië, B1902COS
- Framingham Centro Medico
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Ramos Mejía, Buenos Aires, Argentinië, 1704
- DIM Clinica Privada
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Distrito Federal
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Buenos Aires, Distrito Federal, Argentinië, 1121
- Fundacion CIDEA
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Buenos Aires, Distrito Federal, Argentinië, 1054
- Buenos Aires Skin SA
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Buenos Aires, Distrito Federal, Argentinië, 1414
- Care- Centro de Alergia y Enfermedades Respiratorias
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Buenos Aires, Distrito Federal, Argentinië, 1425
- Psoriahue Medicina Interdisciplinaria SRL
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Santa Fe Province
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Rosario, Santa Fe Province, Argentinië, 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, Australië, 2019
- Emeritus Research Sydney
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Westmead, New South Wales, Australië, 2145
- Westmead Hospital
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Queensland
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Benowa, Queensland, Australië, 4217
- The Skin Centre
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South Brisbane, Queensland, Australië, 4101
- Princess Alexandra Hospital
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Woolloongabba, Queensland, Australië, 4102
- Veracity Clinical Research
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Victoria
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Camberwell, Victoria, Australië, 3124
- Emeritus Research Melbourne
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Bruges, België, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
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Brussels, België, 1090
- Universitair Ziekenhuis Brussel
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Brussels, België, 1020
- Centre Hospitalier Universitaire Brugmann
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Brussels, België, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Ghent, België, 9000
- Universitair Ziekenhuis Gent
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Herstal, België, 4040
- Clinique Andre Renard
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Kortrijk, België, 8500
- Dermatologie Handelskaai
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Leuven, België, 3000
- Universitaire Ziekenhuizen Leuven Gasthuisberg
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Liège, België, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
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Loverval, België, 6280
- Grand Hôpital de Charleroi
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Dupnitsa, Bulgarije, 2600
- Medical Center Asklepii OOD
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Pleven, Bulgarije, 5800
- Medical center Medconsult Pleven OOD
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Sofia, Bulgarije, 1407
- Medical Center Excelsior OOD
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Sofia, Bulgarije, 1431
- Diagnostic-Consultative Center Alexandrovska EOOD
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Sofia, Bulgarije, 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, China, 100044
- Peking University Peoples Hospital
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Shanghai, China, 200443
- Shanghai Skin Disease Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, China, 100050
- Beijing Friendship hospital, Capital Medical University
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Fujian
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Fuzhou, Fujian, China, 350000
- The First Affiliated Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, China, 510091
- Dermatology Hospital of Southern Medical University
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Guangzhou, Guangdong, China, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
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Guangzhou, Guangdong, China, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
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Shantou, Guangdong, China, 515041
- The Fist Affiliated Hospital of Shantou University Medical College
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Shenzhen, Guangdong, China, 518101
- Shenzhen Qianhai Shekou Free Trade Zone Hospital
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Henan
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Nanyang, Henan, China, 473002
- Nanyang First Peoples Hospital
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Hubei
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Wuhan, Hubei, China, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Jiangsu
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Wuxi, Jiangsu, China, 214001
- Wuxi Second Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, China, 330000
- Dermatology Hospital of Jiangxi Province
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Jilin
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Changchun, Jilin, China, 130021
- The First Hospital of Jilin University
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Sichuan
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Chengdu, Sichuan, China, 610017
- Chengdu Second Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, China, 310016
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
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Hangzhou, Zhejiang, China, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
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Ningbo, Zhejiang, China, 315010
- The First Affiliation Hospital Of Ningbo University
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Taizhou, Zhejiang, China, 318000
- Taizhou Central Hospital
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Frankfurt am Main, Duitsland, 60590
- Universitaetsklinikum Frankfurt
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Göttingen, Duitsland, 37075
- Universitaetsmedizin Goettingen - Georg-August-Universitaet
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Hamburg, Duitsland, 22391
- MensingDerma Research GmbH
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Hamburg, Duitsland, 20537
- TFS Trial Form Support GmbH
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Hanover, Duitsland, 30625
- Medizinische Hochschule Hannover
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Hanover, Duitsland, 30159
- Hautaerzte Zentrum Hannover
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Mainz, Duitsland, 55101
- Universitaetsmedizin Mainz
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Memmingen, Duitsland, 87700
- Beldio Research Gmbh
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Merzing, Duitsland, 66663
- Hautmedizin Saar
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München, Duitsland, 80802
- Klinikum rechts der Isar der TUM
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Antony, Frankrijk, 92160
- Hopital Prive d Antony
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Bordeaux, Frankrijk, Cedex
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
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Brest, Frankrijk, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
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Lille, Frankrijk, 59037
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
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Lorient, Frankrijk, 56322
- Centre Hospitalier de Bretagne Sud - Hopital du Scorff
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Marseille, Frankrijk, 13385
- Hôpital La Timone
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Martigues, Frankrijk, 13500
- Cabinet du Docteur Ruer-Mulard Mireille
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Nantes, Frankrijk, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
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Nice, Frankrijk, 06202
- Centre Hospitalier Universitaire Archet 2
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Paris, Frankrijk, 75020
- Hôpital Tenon
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Paris, Frankrijk, 75475
- Hopital Saint Louis
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Paris, Frankrijk, 75018
- Hopital Bichat Claude Bernard
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Reims, Frankrijk, 51100
- Polyclinique de Courlancy
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Rennes, Frankrijk, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Rouen, Frankrijk, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
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Saint-Priest-en-Jarez, Frankrijk, 42270
- Centre Hospitalier Universitaire Saint Etienne Hopital Nord
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Toulon, Frankrijk, 83800
- Hopital d instruction des armees sainte anne
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Athens, Griekenland, 11525
- 401 General Military Hospital Of Athens
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Athens, Griekenland, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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Heraklion, Griekenland, 71500
- University General Hospital of Heraklion
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Nea Ionia, Griekenland, 14233
- General Hospital Of Nea Ionia Konstantopouleio Patision
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Piraeus, Griekenland, 18536
- Geniko Nosokomeio Peiraia Tzaneio
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Thessaloniki, Griekenland, 54642
- Ippokratio General Hospital of Thessaloniki
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Budapest, Hongarije, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, Hongarije, 1027
- Csalogany Orvosi Kozpont
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Budapest, Hongarije, 1033
- Clinexpert Kft
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Békéscsaba, Hongarije, 5600
- Trial Pharma Kft
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Debrecen, Hongarije, 4032
- Debreceni Egyetem Klinikai Kozpont
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Gyöngyös, Hongarije, 3200
- Gyongyosi Bugat Pal Korhaz
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Kaposvár, Hongarije, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Orosháza, Hongarije, 5900
- DermaMed Research Kft
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Szolnok, Hongarije, 5000
- Allergo-Derm Bakos Kft
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Zalaegerszeg, Hongarije, 8900
- Obudai Egeszsegugyi Centrum Kft
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Genova, Italië, 16132
- Ospedale Policlinico San Martino IRCCS
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LAquila, Italië, 67100
- Ospedale San Salvatore
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Roma, Italië, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Rozzano MI, Italië, 20089
- IRCCS Istituto Clinico Humanitas
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 454-0803
- Fukui Dermatology Clinic
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Fukuoka
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Fukuoka, Fukuoka, Japan, 812-0013
- Ekihigashi Dermatology Allergy Clinic
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Hokkaido
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Obihiro-shi, Hokkaido, Japan, 080-0013
- Takagi Dermatological Clinic Branch
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Sapporo, Hokkaido, Japan, 060-0063
- Medical Corporation Kojinkai Sapporo Skin Clinic
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japan, 890-0063
- Katahira Dermatology Urology Clinic
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Kanagawa
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Kawasaki-shi, Kanagawa, Japan, 211-0063
- Kosugi Dermatology Clinic
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Yokohama, Kanagawa, Japan, 221-0825
- Nomura Dermatology Clinic
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Kumamoto
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Kumamoto, Kumamoto, Japan, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
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Kumamoto, Kumamoto, Japan, 862-0950
- Suizenji Dermatology Clinic
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Osaka
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Neyagawa, Osaka, Japan, 572-0838
- Yoshioka Dermatology Clinic
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 430-0929
- JA Shizuoka Kohseiren Enshu Hospital
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Tokyo
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Adachi-ku, Tokyo, Japan, 120-0034
- Mildix Skin Clinic
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Setagaya-ku, Tokyo, Japan, 158-0097
- Naoko Dermatology Clinic
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Shinagawa-ku, Tokyo, Japan, 141-8625
- NTT Medical Center Tokyo
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Shinjuku-ku, Tokyo, Japan, 169-0075
- Yamate Dermatology Clinic
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Johor
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Johor Bahru, Johor, Maleisië, 81100
- Hospital Sultan Ismail
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Maleisië, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Maleisië, 59100
- University Malaya Medical Centre
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Kuala Lumpur, Kuala Lumpur, Maleisië, 56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
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Perak
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Ipoh, Perak, Maleisië, 30450
- Hospital Raja Permaisuri Bainun
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Pulau Pinang
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George Town, Pulau Pinang, Maleisië, 10990
- Hospital Pulau Pinang
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Sabah
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Kota Kinabalu, Sabah, Maleisië, 88586
- Queen Elizabeth Hospital
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Bergen op Zoom, Nederland, 4624 VT
- Bravis Ziekenhuis
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Groningen, Nederland, 9700 RB
- Universitair Medisch Centrum Groningen
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Utrecht, Nederland, 3584 CX
- Universitair Medisch Centrum Utrecht
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Graz, Oostenrijk, 8036
- Medizinische Universitaet Graz
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Innsbruck, Oostenrijk, 6020
- Medizinische Universitaet Innsbruck
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Salzburg, Oostenrijk, 5020
- Landeskrankenhaus Salzburg
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Vienna, Oostenrijk, 1030
- Klinik Landstrasse
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Vienna, Oostenrijk, 1130
- Klinik Hietzing
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Chorzów, Polen, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
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Katowice, Polen, 40-600
- GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
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Krakow, Polen, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
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Lodz, Polen, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Polen, 90-752
- Ip Clinic Sp zoo
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Szczecin, Polen, 71-500
- Twoja Przychodnia SCM
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Wroclaw, Polen, 51-503
- DermMedica Spzoo Centrum Columbus
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Caguas, Puerto Rico, 00727-9507
- Doctor Samuel Sanchez PSC
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Brasov, Roemenië, 500112
- Theramed Healthcare SRL
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Cluj-Napoca, Roemenië, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
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Târgu Mureş, Roemenië, 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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Ljubljana, Slovenië, 1000
- Univerzitetni klinicni center Ljubljana
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Maribor, Slovenië, 2000
- Univerzitetni Klinicni Center Maribor
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Bardejov, Slowakije, 085 01
- Maxderm, sro
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Bratislava, Slowakije, 813 69
- Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
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Prešov, Slowakije, 081 81
- Fakultna nemocnica s poliklinikou JA Reimana Presov
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Svidník, Slowakije, 089 01
- Sanare spol sro
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Madrid, Spanje, 28041
- Hospital Universitario 12 de Octubre
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Pontevedra, Spanje, 36001
- Complexo Hospitalario Universitario de Pontevedra
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Basque Country
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Bilbao, Basque Country, Spanje, 48013
- Hospital Universitario Basurto
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Catalonia
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Barcelona, Catalonia, Spanje, 08036
- Hospital Clinic i Provincial de Barcelona
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Valencia
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Valencia, Valencia, Spanje, 46014
- Hospital General Universitario de Valencia
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Ankara, Turkije (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
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Istanbul, Turkije (Türkiye), 34390
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
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Istanbul, Turkije (Türkiye), 34662
- Acibadem Altunizade Hastanesi
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Istanbul, Turkije (Türkiye), 34899
- Marmara Universitesi Tip Fakultesi Hastanesi
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Samsun, Turkije (Türkiye), 55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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Bath, Verenigd Koninkrijk, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
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Dudley, Verenigd Koninkrijk, DY1 2HQ
- Russells Hall Hospital
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Isleworth, Verenigd Koninkrijk, TW7 6AF
- West Middlesex University Hospital
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London, Verenigd Koninkrijk, NW3 2PF
- The Royal Free Hospital
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Salford, Verenigd Koninkrijk, M6 8HD
- Salford Care Organisation
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Shipley, Verenigd Koninkrijk, BD18 3SA
- Accellacare Yorkshire
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35233
- The University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85006
- Medical Dermatology Specialists
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Phoenix, Arizona, Verenigde Staten, 85018
- Southwest Skin Specialists
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Sun City West, Arizona, Verenigde Staten, 85375
- US Dermatology Partners Sun City West
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Arkansas
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North Little Rock, Arkansas, Verenigde Staten, 72117
- Arkansas Research Trials, LLC
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California
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Bakersfield, California, Verenigde Staten, 93301
- Kern Research Inc
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Los Angeles, California, Verenigde Staten, 90056
- Wallace Medical Group Inc
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Los Angeles, California, Verenigde Staten, 90033
- Keck Medicine of University of Southern California
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Palmdale, California, Verenigde Staten, 93551
- Antelope Valley Clinical Trials
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Sacramento, California, Verenigde Staten, 95816
- University of California at Davis Medical Center
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Sacramento, California, Verenigde Staten, 95823
- Kaiser Permanente South Sacramento Medical Center
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San Diego, California, Verenigde Staten, 92120
- Acclaim Clinical Research
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San Francisco, California, Verenigde Staten, 94132
- Synergy Dermatology
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San Francisco, California, Verenigde Staten, 94118
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Verenigde Staten, 94118
- Kaiser Permanente Medical Center - San Francisco
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Florida
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Tampa, Florida, Verenigde Staten, 33609
- TrueBlue Clinical Research
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Tampa, Florida, Verenigde Staten, 33615
- Olympian Clinical Research - Tampa
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Georgia
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Alpharetta, Georgia, Verenigde Staten, 30022
- Atlanta Dermatology, Vein and Research Center, PC
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Atlanta, Georgia, Verenigde Staten, 30315
- Divine Dermatology and Aesthetics
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Illinois
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Skokie, Illinois, Verenigde Staten, 60077
- Northshore University Healthsystem
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Indiana
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Clarksville, Indiana, Verenigde Staten, 47129
- DS Research
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Indianapolis, Indiana, Verenigde Staten, 46250
- Dawes Fretzin Clinical Research Group, LLC
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Kansas
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Leawood, Kansas, Verenigde Staten, 66211
- Dermatology and Skin Cancer Center Leawood
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Louisiana
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Monroe, Louisiana, Verenigde Staten, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
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Maryland
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Rockville, Maryland, Verenigde Staten, 20850
- Aesthetic and Dermatology Center
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan Medical Center
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Auburn Hills, Michigan, Verenigde Staten, 48326
- Oakland Hills Dermatology
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Nebraska
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Lincoln, Nebraska, Verenigde Staten, 68505
- Somnos Clinical Research
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Omaha, Nebraska, Verenigde Staten, 68144
- Skin Specialists PC
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89119
- Vivida Dermatology
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North Las Vegas, Nevada, Verenigde Staten, 89030
- Las Vegas Clinical Trials
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New Jersey
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Hackensack, New Jersey, Verenigde Staten, 07601
- Schweiger Dermatology Group, PC Research Division
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87102
- Albuquerque Clinical Trials Incorporated
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New York
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The Bronx, New York, Verenigde Staten, 10455
- CHEAR Center LLC
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North Carolina
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Wilmington, North Carolina, Verenigde Staten, 28401
- Accellacare of Wilmington
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Ohio
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Bexley, Ohio, Verenigde Staten, 43209
- Bexley Dermatology Research
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Oregon
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Medford, Oregon, Verenigde Staten, 97504
- Velocity Clinical Research Inc
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19103
- Paddington Testing Company Inc
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- University of Pittsburgh Medical Center
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South Dakota
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Rapid City, South Dakota, Verenigde Staten, 57702
- Health Concepts
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Texas
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Austin, Texas, Verenigde Staten, 78759
- US Dermatology Partners Jollyville
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El Paso, Texas, Verenigde Staten, 79925
- Newco 3A Research LLC
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Kerrville, Texas, Verenigde Staten, 78028
- Sante Clinical Research
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Plano, Texas, Verenigde Staten, 75025
- Texas Dermatology Research Center
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Virginia
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Norfolk, Virginia, Verenigde Staten, 23502
- Virginia Dermatology and Skin Cancer Center
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Bern, Zwitserland, 3010
- Inselspital Bern
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Geneva, Zwitserland, 1211
- Hopitaux Universitaires de Geneve
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Lausanne, Zwitserland, 1011
- Centre Hospitalier Universitaire Vaudois
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Sankt Gallen, Zwitserland, 9007
- Kantonsspital Sankt Gallen
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Zurich, Zwitserland, 8091
- Universitaetsspital Zuerich
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 100 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusiecriteria:
- Leeftijd ≥ 18 jaar met een diagnose van AD volgens de AAD (American Academy of Dermatology) Consensus Criteria (2014) aanwezig gedurende ten minste 6 maanden
- Geschiedenis van onvoldoende respons op TCS van gemiddelde of hogere potentie binnen 6 maanden (met of zonder TCI)
- EASI-score ≥16
- vIGA-AD-score ≥3
- ≥10% lichaamsoppervlak (BSA) van AD-betrokkenheid
- Slechtste pruritus numerieke beoordelingsschaal ≥ 4
Uitsluitingscriteria:
- Behandeling met een biologisch product binnen 12 weken of 5 halfwaardetijden, afhankelijk van welke langer is, voorafgaand aan Dag 1
Behandeling met een van de volgende medicijnen of therapieën binnen 4 weken of 5 halfwaardetijden, afhankelijk van welke langer is, voorafgaand aan dag 1:
- Systemische corticosteroïden
- Systemische immunosuppressiva
- Fototherapie
- Januskinaseremmers
Behandeling met een van de volgende medicijnen of therapieën binnen 1 week, voorafgaand aan Dag 1:
- TCS
- TCI
- Middelen tegen jeuk
- Topische fosfodiësterase type 4-remmers
- Andere lokale immunosuppressiva
- Combinatie van topische middelen, waaronder TCS van elke potentie of TCI, PDE4-remmers of andere topische immunosuppressieve middelen
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Rocatinlimab dosis 1 + TCS/TCI
Rocatinlimab dosis 1 elke 4 weken (Q4W) gedurende 24 weken + TCS/TCI + oplaaddosis in week 2.
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Subcutane (SC) injectie
Andere namen:
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Experimenteel: Rocatinlimab dosis 2 + TCS/TCI
Rocatinlimab dosis 2 Q4W gedurende 24 weken + TCS/TCI + oplaaddosis in week 2.
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Subcutane (SC) injectie
Andere namen:
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Placebo-vergelijker: Placebo + TCS/TCI
Placebo Q4W gedurende 24 weken + TCS/TCI + oplaaddosis in week 2.
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SC-injectie
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Tijdsspanne: 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.
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Baseline and Week 24
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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
Tijdsspanne: 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.
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Baseline and Week 24
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Participants Who Achieved EASI 75 at Week 16
Tijdsspanne: 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.
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Baseline and Week 16
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Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (vIGA-AD 0/1) at Week 16
Tijdsspanne: 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.
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Baseline and Week 16
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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
Tijdsspanne: Baseline and Week 16
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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.
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Baseline and Week 16
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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
Tijdsspanne: 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.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Tijdsspanne: 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.
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Baseline and Week 24
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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
Tijdsspanne: 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.
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Baseline and Week 24
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Number of Participants Who Achieved Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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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
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in DLQI Score at Week 24
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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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
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in POEM Score at Week 24
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Tijdsspanne: 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.
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Baseline and Week 16
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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
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in HADS-anxiety Subscale Score at Week 24
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in HADS-depression Subscale Score at Week 24
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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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
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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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
Tijdsspanne: 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.
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Baseline and Week 24
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Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Tijdsspanne: Baseline and Week 16
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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.
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Baseline and Week 16
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Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Tijdsspanne: Baseline and Week 16
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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.
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Baseline and Week 16
|
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Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Tijdsspanne: 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
|
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Change From Baseline in SCORAD Itch VAS Score at Week 24
Tijdsspanne: 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.
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Baseline and Week 24
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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
Tijdsspanne: Baseline and Week 16
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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.
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Baseline and Week 16
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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
Tijdsspanne: Baseline and Week 24
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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.
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Baseline and Week 24
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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
Tijdsspanne: 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.
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Baseline and Week 16
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: MD, Amgen
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
21 februari 2023
Primaire voltooiing (Werkelijk)
15 september 2024
Studie voltooiing (Werkelijk)
4 december 2024
Studieregistratiedata
Eerst ingediend
2 februari 2023
Eerst ingediend dat voldeed aan de QC-criteria
2 februari 2023
Eerst geplaatst (Werkelijk)
13 februari 2023
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
4 augustus 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20210144
- 2022-501585-22-00 (Register-ID: CTIS (EU))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Geanonimiseerde individuele patiëntgegevens voor variabelen die nodig zijn om de specifieke onderzoeksvraag te beantwoorden in een goedgekeurd verzoek om gegevensuitwisseling.
IPD-tijdsbestek voor delen
Verzoeken tot het delen van gegevens met betrekking tot deze studie worden overwogen vanaf 18 maanden nadat de studie is beëindigd en ofwel 1) voor het product en de indicatie een vergunning voor het in de handel brengen is verleend in zowel de VS als Europa, of 2) de klinische ontwikkeling van het product en/of de indicatie wordt stopgezet en de gegevens zullen niet worden ingediend bij regelgevende instanties.
Er is geen einddatum voor het in aanmerking komen voor het indienen van een verzoek om gegevensuitwisseling voor dit onderzoek.
IPD-toegangscriteria voor delen
Gekwalificeerde onderzoekers kunnen een verzoek indienen met daarin de onderzoeksdoelstellingen, het/de Amgen-product(en) en de Amgen-studie(s) in de reikwijdte, eindpunten/uitkomsten van belang, plan voor statistische analyse, gegevensvereisten, publicatieplan en kwalificaties van de onderzoeker(s).
Over het algemeen willigt Amgen geen externe verzoeken in voor individuele patiëntgegevens met als doel veiligheids- en werkzaamheidskwesties die al in de productetikettering aan bod zijn gekomen, opnieuw te evalueren.
Verzoeken worden beoordeeld door een commissie van interne adviseurs.
Indien niet goedgekeurd, zal een onafhankelijk beoordelingspanel voor gegevensuitwisseling arbitreren en de uiteindelijke beslissing nemen.
Na goedkeuring wordt de informatie die nodig is om de onderzoeksvraag te beantwoorden verstrekt onder de voorwaarden van een overeenkomst voor het delen van gegevens.
Dit kunnen geanonimiseerde individuele patiëntgegevens en/of beschikbare ondersteunende documenten zijn, die fragmenten van de analysecode bevatten, indien voorzien in de analysespecificaties.
Verdere details zijn beschikbaar op de onderstaande URL.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .