Eine Studie zur Bewertung von Rocatinlimab in Kombination mit topischen Kortikosteroiden und/oder topischen Calcineurin-Inhibitoren bei erwachsenen Teilnehmern mit mittelschwerer bis schwerer atopischer Dermatitis (AD) (ROCKET-SHUTTLE)
4. August 2026 aktualisiert von: Amgen
Eine randomisierte, 24-wöchige, placebokontrollierte Doppelblindstudie der Phase 3 zur Bewertung der Wirksamkeit, Sicherheit und Verträglichkeit von Rocatinlimab (AMG 451) in Kombination mit topischen Kortikosteroiden und/oder topischen Calcineurin-Inhibitoren bei erwachsenen Probanden mit mittelschwerer bis schwerer atopischer Dermatitis (AD) (ROCKET-SHUTTLE)
Die koprimären Ziele der Studie sind:
- Bewertung der Wirksamkeit von Rocatinlimab in Kombination mit topischem Kortikosteroid und/oder topischem Calcineurin-Inhibitor (TCS/TCI) im Vergleich zu Placebo in Kombination mit TCS/TCI in Woche 24, bewertet anhand des Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) .
- Bewertung der Wirksamkeit von Rocatinlimab in Kombination mit TCS/TCI im Vergleich zu Placebo in Kombination mit TCS/TCI in Woche 24, bewertet anhand des Eczema Area and Severity Index (EASI).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
746
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Buenos Aires
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CABA, Buenos Aires, Argentinien, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
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La Plata, Buenos Aires, Argentinien, B1902COS
- Framingham Centro Medico
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Ramos Mejía, Buenos Aires, Argentinien, 1704
- DIM Clinica Privada
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Distrito Federal
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Buenos Aires, Distrito Federal, Argentinien, 1121
- Fundacion CIDEA
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Buenos Aires, Distrito Federal, Argentinien, 1054
- Buenos Aires Skin SA
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Buenos Aires, Distrito Federal, Argentinien, 1414
- Care- Centro de Alergia y Enfermedades Respiratorias
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Buenos Aires, Distrito Federal, Argentinien, 1425
- Psoriahue Medicina Interdisciplinaria SRL
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Santa Fe Province
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Rosario, Santa Fe Province, Argentinien, 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, Australien, 2019
- Emeritus Research Sydney
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Westmead, New South Wales, Australien, 2145
- Westmead Hospital
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Queensland
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Benowa, Queensland, Australien, 4217
- The Skin Centre
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South Brisbane, Queensland, Australien, 4101
- Princess Alexandra Hospital
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Woolloongabba, Queensland, Australien, 4102
- Veracity Clinical Research
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Victoria
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Camberwell, Victoria, Australien, 3124
- Emeritus Research Melbourne
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Bruges, Belgien, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
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Brussels, Belgien, 1090
- Universitair Ziekenhuis Brussel
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Brussels, Belgien, 1020
- Centre Hospitalier Universitaire Brugmann
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Brussels, Belgien, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Ghent, Belgien, 9000
- Universitair Ziekenhuis Gent
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Herstal, Belgien, 4040
- Clinique Andre Renard
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Kortrijk, Belgien, 8500
- Dermatologie Handelskaai
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Leuven, Belgien, 3000
- Universitaire Ziekenhuizen Leuven Gasthuisberg
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Liège, Belgien, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
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Loverval, Belgien, 6280
- Grand Hôpital de Charleroi
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Dupnitsa, Bulgarien, 2600
- Medical Center Asklepii OOD
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Pleven, Bulgarien, 5800
- Medical center Medconsult Pleven OOD
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Sofia, Bulgarien, 1407
- Medical Center Excelsior OOD
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Sofia, Bulgarien, 1431
- Diagnostic-Consultative Center Alexandrovska EOOD
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Sofia, Bulgarien, 1463
- Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
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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, Deutschland, 60590
- Universitaetsklinikum Frankfurt
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Göttingen, Deutschland, 37075
- Universitaetsmedizin Goettingen - Georg-August-Universitaet
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Hamburg, Deutschland, 22391
- MensingDerma Research GmbH
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Hamburg, Deutschland, 20537
- TFS Trial Form Support GmbH
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Hanover, Deutschland, 30625
- Medizinische Hochschule Hannover
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Hanover, Deutschland, 30159
- Hautaerzte Zentrum Hannover
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Mainz, Deutschland, 55101
- Universitaetsmedizin Mainz
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Memmingen, Deutschland, 87700
- Beldio Research Gmbh
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Merzing, Deutschland, 66663
- Hautmedizin Saar
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München, Deutschland, 80802
- Klinikum rechts der Isar der TUM
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Antony, Frankreich, 92160
- Hopital Prive d Antony
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Bordeaux, Frankreich, Cedex
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
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Brest, Frankreich, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
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Lille, Frankreich, 59037
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
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Lorient, Frankreich, 56322
- Centre Hospitalier de Bretagne Sud - Hopital du Scorff
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Marseille, Frankreich, 13385
- Hôpital La Timone
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Martigues, Frankreich, 13500
- Cabinet du Docteur Ruer-Mulard Mireille
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Nantes, Frankreich, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
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Nice, Frankreich, 06202
- Centre Hospitalier Universitaire Archet 2
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Paris, Frankreich, 75020
- Hôpital Tenon
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Paris, Frankreich, 75475
- Hopital Saint Louis
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Paris, Frankreich, 75018
- Hopital Bichat Claude Bernard
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Reims, Frankreich, 51100
- Polyclinique de Courlancy
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Rennes, Frankreich, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Rouen, Frankreich, 76031
- Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
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Saint-Priest-en-Jarez, Frankreich, 42270
- Centre Hospitalier Universitaire Saint Etienne Hopital Nord
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Toulon, Frankreich, 83800
- Hopital d instruction des armees sainte anne
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Athens, Griechenland, 11525
- 401 General Military Hospital Of Athens
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Athens, Griechenland, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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Heraklion, Griechenland, 71500
- University General Hospital of Heraklion
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Nea Ionia, Griechenland, 14233
- General Hospital Of Nea Ionia Konstantopouleio Patision
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Piraeus, Griechenland, 18536
- Geniko Nosokomeio Peiraia Tzaneio
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Thessaloniki, Griechenland, 54642
- Ippokratio General Hospital of Thessaloniki
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Genova, Italien, 16132
- Ospedale Policlinico San Martino IRCCS
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LAquila, Italien, 67100
- Ospedale San Salvatore
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Roma, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Rozzano MI, Italien, 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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Alberta
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Calgary, Alberta, Kanada, T2J 7E1
- Dermatology Research Institute Incorporated
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Edmonton, Alberta, Kanada, T5J 3S9
- Laser Rejuvenation Clinics Edmonton D T Incorporated
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Edmonton, Alberta, Kanada, T6G 1C3
- Alberta Derma Surgery Centre
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British Columbia
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Surrey, British Columbia, Kanada, V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg, Manitoba, Kanada, R3M 3Z4
- Wiseman Dermatology Research Incorporated
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Ontario
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Coburg, Ontario, Kanada, K9A 4J9
- Skin Health
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London, Ontario, Kanada, N6A 2C2
- Centricity Research London
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Newmarket, Ontario, Kanada, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
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Niagara Falls, Ontario, Kanada, L2H 1H5
- Allergy Research Canada Incorporated
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North Bay, Ontario, Kanada, P1B 3Z7
- North Bay Dermatology Centre
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Ottawa, Ontario, Kanada, K2C 3N2
- Dermatology Ottawa Research Centre
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Ottawa, Ontario, Kanada, K2C 3N2
- JRB Research Incorporated
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Richmond Hill, Ontario, Kanada, L4B 1A5
- The Centre for Dermatology
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Toronto, Ontario, Kanada, M2N 3A6
- North York Research Incorporated
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Toronto, Ontario, Kanada, M3H 5Y8
- Toronto Research Centre Inc
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Waterloo, Ontario, Kanada, N2J 1C4
- Alliance Clinical Trials
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Quebec
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Montreal, Quebec, Kanada, H2X 2V1
- Innovaderm Research Inc
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Montreal, Quebec, Kanada, H1Y 3L1
- Clinique de Dermatologie Rosemont
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Québec, Quebec, Kanada, G1W 4R4
- Centre de Recherche Saint-Louis
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Québec, Quebec, Kanada, G1V 4T3
- Diex Recherche Québec
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7T 0G3
- Saskatoon Dermatology Centre
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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, Niederlande, 4624 VT
- Bravis Ziekenhuis
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Groningen, Niederlande, 9700 RB
- Universitair Medisch Centrum Groningen
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Utrecht, Niederlande, 3584 CX
- Universitair Medisch Centrum Utrecht
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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, Rumänien, 500112
- Theramed Healthcare SRL
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Cluj-Napoca, Rumänien, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
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Târgu Mureş, Rumänien, 540613
- Spitalul Clinic Judetean Mures
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Bern, Schweiz, 3010
- Inselspital Bern
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Geneva, Schweiz, 1211
- Hôpitaux Universitaires de Genève
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Lausanne, Schweiz, 1011
- Centre hospitalier universitaire vaudois
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Sankt Gallen, Schweiz, 9007
- Kantonsspital Sankt Gallen
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Zurich, Schweiz, 8091
- Universitaetsspital Zuerich
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Singapore, Singapur, 308205
- National Skin Centre
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Singapore, Singapur, 168753
- Singapore General Hospital
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Singapore, Singapur, 117599
- National University Hospital
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Bardejov, Slowakei, 085 01
- Maxderm, sro
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Bratislava, Slowakei, 813 69
- Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
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Prešov, Slowakei, 081 81
- Fakultna nemocnica s poliklinikou JA Reimana Presov
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Svidník, Slowakei, 089 01
- Sanare spol sro
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Ljubljana, Slowenien, 1000
- Univerzitetni klinicni center Ljubljana
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Maribor, Slowenien, 2000
- Univerzitetni Klinicni Center Maribor
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre
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Pontevedra, Spanien, 36001
- Complexo Hospitalario Universitario de Pontevedra
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Basque Country
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Bilbao, Basque Country, Spanien, 48013
- Hospital Universitario Basurto
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Catalonia
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Barcelona, Catalonia, Spanien, 08036
- Hospital Clinic i Provincial de Barcelona
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Valencia
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Valencia, Valencia, Spanien, 46014
- Hospital General Universitario de Valencia
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Ankara, Türkei (türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
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Istanbul, Türkei (türkiye), 34390
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
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Istanbul, Türkei (türkiye), 34662
- Acibadem Altunizade Hastanesi
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Istanbul, Türkei (türkiye), 34899
- Marmara Universitesi Tip Fakultesi Hastanesi
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Samsun, Türkei (türkiye), 55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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Budapest, Ungarn, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, Ungarn, 1027
- Csalogany Orvosi Kozpont
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Budapest, Ungarn, 1033
- Clinexpert Kft
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Békéscsaba, Ungarn, 5600
- Trial Pharma Kft
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Debrecen, Ungarn, 4032
- Debreceni Egyetem Klinikai Kozpont
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Gyöngyös, Ungarn, 3200
- Gyongyosi Bugat Pal Korhaz
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Kaposvár, Ungarn, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Orosháza, Ungarn, 5900
- DermaMed Research Kft
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Szolnok, Ungarn, 5000
- Allergo-Derm Bakos Kft
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Zalaegerszeg, Ungarn, 8900
- Obudai Egeszsegugyi Centrum Kft
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35233
- The University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85006
- Medical Dermatology Specialists
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Phoenix, Arizona, Vereinigte Staaten, 85018
- Southwest Skin Specialists
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Sun City West, Arizona, Vereinigte Staaten, 85375
- US Dermatology Partners Sun City West
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Arkansas
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North Little Rock, Arkansas, Vereinigte Staaten, 72117
- Arkansas Research Trials, LLC
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California
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Bakersfield, California, Vereinigte Staaten, 93301
- Kern Research Inc
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Los Angeles, California, Vereinigte Staaten, 90056
- Wallace Medical Group Inc
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Los Angeles, California, Vereinigte Staaten, 90033
- Keck Medicine of University of Southern California
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Palmdale, California, Vereinigte Staaten, 93551
- Antelope Valley Clinical Trials
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Sacramento, California, Vereinigte Staaten, 95816
- University of California at Davis Medical Center
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Sacramento, California, Vereinigte Staaten, 95823
- Kaiser Permanente South Sacramento Medical Center
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San Diego, California, Vereinigte Staaten, 92120
- Acclaim Clinical Research
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San Francisco, California, Vereinigte Staaten, 94132
- Synergy Dermatology
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San Francisco, California, Vereinigte Staaten, 94118
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Vereinigte Staaten, 94118
- Kaiser Permanente Medical Center - San Francisco
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Florida
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Tampa, Florida, Vereinigte Staaten, 33609
- TrueBlue Clinical Research
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Tampa, Florida, Vereinigte Staaten, 33615
- Olympian Clinical Research - Tampa
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Georgia
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Alpharetta, Georgia, Vereinigte Staaten, 30022
- Atlanta Dermatology, Vein and Research Center, PC
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Atlanta, Georgia, Vereinigte Staaten, 30315
- Divine Dermatology and Aesthetics
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Illinois
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Skokie, Illinois, Vereinigte Staaten, 60077
- NorthShore University HealthSystem
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Indiana
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Clarksville, Indiana, Vereinigte Staaten, 47129
- DS Research
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Indianapolis, Indiana, Vereinigte Staaten, 46250
- Dawes Fretzin Clinical Research Group, LLC
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Kansas
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Leawood, Kansas, Vereinigte Staaten, 66211
- Dermatology and Skin Cancer Center Leawood
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Louisiana
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Monroe, Louisiana, Vereinigte Staaten, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
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Maryland
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Rockville, Maryland, Vereinigte Staaten, 20850
- Aesthetic and Dermatology Center
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109
- University of Michigan Medical Center
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Auburn Hills, Michigan, Vereinigte Staaten, 48326
- Oakland Hills Dermatology
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Nebraska
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Lincoln, Nebraska, Vereinigte Staaten, 68505
- Somnos Clinical Research
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Omaha, Nebraska, Vereinigte Staaten, 68144
- Skin Specialists PC
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89119
- Vivida Dermatology
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North Las Vegas, Nevada, Vereinigte Staaten, 89030
- Las Vegas Clinical Trials
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New Jersey
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Hackensack, New Jersey, Vereinigte Staaten, 07601
- Schweiger Dermatology Group, PC Research Division
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New Mexico
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Albuquerque, New Mexico, Vereinigte Staaten, 87102
- Albuquerque Clinical Trials Incorporated
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New York
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The Bronx, New York, Vereinigte Staaten, 10455
- Chear Center LLC
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North Carolina
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Wilmington, North Carolina, Vereinigte Staaten, 28401
- Accellacare of Wilmington
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Ohio
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Bexley, Ohio, Vereinigte Staaten, 43209
- Bexley dermatology research
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Oregon
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Medford, Oregon, Vereinigte Staaten, 97504
- Velocity Clinical Research Inc
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19103
- Paddington Testing Company Inc
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- University of Pittsburgh Medical Center
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South Dakota
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Rapid City, South Dakota, Vereinigte Staaten, 57702
- Health Concepts
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Texas
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Austin, Texas, Vereinigte Staaten, 78759
- US Dermatology Partners Jollyville
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El Paso, Texas, Vereinigte Staaten, 79925
- Newco 3A Research LLC
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Kerrville, Texas, Vereinigte Staaten, 78028
- Sante Clinical Research
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Plano, Texas, Vereinigte Staaten, 75025
- Texas Dermatology Research Center
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Virginia
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Norfolk, Virginia, Vereinigte Staaten, 23502
- Virginia Dermatology and Skin Cancer Center
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Bath, Vereinigtes Königreich, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
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Dudley, Vereinigtes Königreich, DY1 2HQ
- Russells Hall Hospital
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Isleworth, Vereinigtes Königreich, TW7 6AF
- West Middlesex University Hospital
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London, Vereinigtes Königreich, NW3 2PF
- The Royal Free Hospital
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Salford, Vereinigtes Königreich, M6 8HD
- Salford Care Organisation
-
Shipley, Vereinigtes Königreich, BD18 3SA
- Accellacare Yorkshire
-
-
-
-
-
Graz, Österreich, 8036
- Medizinische Universitaet Graz
-
Innsbruck, Österreich, 6020
- Medizinische Universitaet Innsbruck
-
Salzburg, Österreich, 5020
- Landeskrankenhaus Salzburg
-
Vienna, Österreich, 1030
- Klinik Landstraße
-
Vienna, Österreich, 1130
- Klinik Hietzing
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 100 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Einschlusskriterien:
- Alter ≥ 18 Jahre mit einer AD-Diagnose gemäß AAD (American Academy of Dermatology) Consensus Criteria (2014) seit mindestens 6 Monaten
- Anamnestisch unzureichendes Ansprechen auf TCS mittlerer oder höherer Potenz innerhalb von 6 Monaten (mit oder ohne TCI)
- EASI-Score ≥16
- vIGA-AD-Score ≥3
- ≥10 % Körperoberfläche (BSA) der AD-Beteiligung
- Schlimmste numerische Bewertungsskala für Juckreiz ≥ 4
Ausschlusskriterien:
- Behandlung mit einem biologischen Produkt innerhalb von 12 Wochen oder 5 Halbwertszeiten, je nachdem, was länger ist, vor Tag 1
Behandlung mit einem der folgenden Medikamente oder Therapien innerhalb von 4 Wochen oder 5 Halbwertszeiten, je nachdem, was länger ist, vor Tag 1:
- Systemische Kortikosteroide
- Systemische Immunsuppressiva
- Phototherapie
- Januskinase-Inhibitoren
Behandlung mit einem der folgenden Medikamente oder Therapien innerhalb von 1 Woche vor Tag 1:
- TKS
- TCI
- Mittel gegen Juckreiz
- Topische Phosphodiesterase-Typ-4-Hemmer
- Andere topische Immunsuppressiva
- Topische Kombinationswirkstoffe einschließlich TCS jeder Potenz oder TCI, PDE4-Hemmer oder andere topische Immunsuppressiva
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Rocatinlimab Dosis 1 + TCS/TCI
Rocatinlimab Dosis 1 alle 4 Wochen (Q4W) für 24 Wochen + TCS/TCI + Aufsättigungsdosis in Woche 2.
|
Subkutane (SC) Injektion
Andere Namen:
|
|
Experimental: Rocatinlimab Dosis 2 + TCS/TCI
Rocatinlimab Dosis 2 Q4W für 24 Wochen + TCS/TCI + Aufsättigungsdosis in Woche 2.
|
Subkutane (SC) Injektion
Andere Namen:
|
|
Placebo-Komparator: Placebo + TCS/TCI
Placebo Q4W für 24 Wochen + TCS/TCI + Aufsättigungsdosis in Woche 2.
|
SC-Injektion
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: MD, Amgen
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
21. Februar 2023
Primärer Abschluss (Tatsächlich)
15. September 2024
Studienabschluss (Tatsächlich)
4. Dezember 2024
Studienanmeldedaten
Zuerst eingereicht
2. Februar 2023
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Februar 2023
Zuerst gepostet (Tatsächlich)
13. Februar 2023
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. August 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Genetische Krankheiten, angeboren
- Erkrankungen des Immunsystems
- Überempfindlichkeit, sofort
- Überempfindlichkeit
- Hautkrankheiten
- Hautkrankheiten, genetisch
- Hautkrankheiten, Ekzem
- Dermatitis
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Haut- und Bindegewebserkrankungen
- Dermatitis, atopisch
- Ekzem
Andere Studien-ID-Nummern
- 20210144
- 2022-501585-22-00 (Registrierungskennung: CTIS (EU))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Anonymisierte individuelle Patientendaten für Variablen, die zur Beantwortung der spezifischen Forschungsfrage in einem genehmigten Antrag auf gemeinsame Nutzung von Daten erforderlich sind.
IPD-Sharing-Zeitrahmen
Anfragen zur gemeinsamen Nutzung von Daten im Zusammenhang mit dieser Studie werden ab 18 Monaten nach Abschluss der Studie berücksichtigt, wenn entweder 1) das Produkt und die Indikation sowohl in den USA als auch in Europa eine Marktzulassung erhalten haben oder 2) die klinische Entwicklung für das Produkt und/oder die Indikation eingestellt wurde und die Daten werden nicht an Aufsichtsbehörden übermittelt.
Es gibt kein Enddatum für die Berechtigung zur Einreichung eines Antrags auf gemeinsame Nutzung von Daten für diese Studie.
IPD-Sharing-Zugriffskriterien
Qualifizierte Forscher können eine Anfrage einreichen, die die Forschungsziele, das/die Amgen-Produkt(e) und Amgen-Studie(n) im Umfang, Endpunkte/Ergebnisse von Interesse, statistischen Analyseplan, Datenanforderungen, Veröffentlichungsplan und Qualifikationen des/der Forscher(s) enthält.
Im Allgemeinen gewährt Amgen keine externen Anfragen nach individuellen Patientendaten zum Zwecke der Neubewertung von Sicherheits- und Wirksamkeitsfragen, die bereits in der Produktkennzeichnung angesprochen wurden.
Anträge werden von einem Ausschuss interner Berater geprüft.
Wenn dies nicht genehmigt wird, entscheidet ein unabhängiges Prüfgremium für die gemeinsame Nutzung von Daten und trifft die endgültige Entscheidung.
Nach der Genehmigung werden die zur Beantwortung der Forschungsfrage erforderlichen Informationen im Rahmen einer Vereinbarung zur gemeinsamen Nutzung von Daten bereitgestellt.
Dazu können anonymisierte individuelle Patientendaten und/oder verfügbare unterstützende Dokumente gehören, die Fragmente des Analysecodes enthalten, sofern dies in den Analysespezifikationen vorgesehen ist.
Weitere Einzelheiten finden Sie unter der nachstehenden URL.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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