Eine Placebo-kontrollierte, doppelblinde Phase-3-Studie zur Bewertung der Rocatinlimab (AMG 451)-Monotherapie bei mittelschwerer bis schwerer atopischer Dermatitis (AD) (ROCKET-Horizon) (ROCKET-Horizon)
2. Juni 2026 aktualisiert von: Amgen
Eine randomisierte, 24-wöchige, placebokontrollierte Doppelblindstudie der Phase 3 zur Bewertung der Wirksamkeit, Sicherheit und Verträglichkeit von Rocatinlimab (AMG 451) als Monotherapie bei erwachsenen Probanden mit mittelschwerer bis schwerer atopischer Dermatitis (AD) (ROCKET- Horizont)
Die co-primären Ziele der Studie sind:
- Bewerten Sie die Wirksamkeit von Rocatinlimab im Vergleich zu Placebo in Woche 24, beurteilt anhand des Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
- Bewerten Sie die Wirksamkeit von Rocatinlimab im Vergleich zu Placebo in Woche 24, bewertet anhand des Eczema Area and Severity Index (EASI).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
726
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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New South Wales
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Darlinghurst, New South Wales, Australien, 2010
- St George Dermatology and Skin Cancer Centre
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Kogarah, New South Wales, Australien, 2217
- Premier Specialists
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Victoria
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Box Hill, Victoria, Australien, 3128
- Box Hill Hospital
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Carlton, Victoria, Australien, 3053
- Skin Health Institute
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East Melbourne, Victoria, Australien, 3002
- Sinclair Dermatology
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Melbourne, Victoria, Australien, 3004
- The Alfred Hospital
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Parkville, Victoria, Australien, 3050
- The Royal Melbourne Hospital
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Brussels, Belgien, 1070
- Hopital Erasme
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Herstal, Belgien, 4040
- Clinique Andre Renard
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Maldegem, Belgien, 9990
- Dermatologie Maldegem
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Paraná
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Curitiba, Paraná, Brasilien, 80030-110
- CETI - Centro de Estudo em Terapias Inovadoras
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São Paulo
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São Bernardo do Campo, São Paulo, Brasilien, 09715-090
- Centro Multidisciplinar de Estudos Clínicos - CEMEC
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São José dos Campos, São Paulo, Brasilien, 12243-280
- ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
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Bad Bentheim, Deutschland, 48455
- Fachklinik Bad Bentheim
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Berlin, Deutschland, 10247
- Hautzentrum Friedrichshain - Dermatologie
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Berlin, Deutschland, 13672
- Clinical Research Services Berlin GmbH
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Halle, Deutschland, 06120
- Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
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Hamburg, Deutschland, 20354
- Dermatologikum Hamburg
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Kiel, Deutschland, 24105
- Universitaetsklinikum Schleswig-Holstein
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Leipzig, Deutschland, 04103
- Velocity Clinical Research
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Münster, Deutschland, 48149
- Universitaetsklinikum Muenster
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Osnabrück, Deutschland, 49074
- KliFOs Klinische Forschung Osnabrueck
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Remscheid, Deutschland, 42897
- Hautarztpraxis Mortazawi
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Wuppertal, Deutschland, 42283
- Helios Klinikum Wuppertal
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Hellerup, Dänemark, 2900
- Gentofte Hospital
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Odense, Dänemark, 5000
- Odense University Hospital
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Tallinn, Estland, 13419
- North Estonia Medical Centre
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Tartu, Estland, 50106
- Clinical Research Centre
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Helsinki, Finnland, 00180
- CRST Helsinki
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Helsinki, Finnland, 00180
- CRST Turku
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Oulu, Finnland, 90029
- Oulun Yliopistollinen sairaala (OYS)
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Tampere, Finnland, 33100
- Terveystalo Tampere
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Chiba
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Matsudo-shi, Chiba, Japan, 271-0092
- Miyata Dermatology Clinic
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Narita-shi, Chiba, Japan, 286-8520
- International University of Health and Welfare Narita Hospital
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0017
- Kobe University Hospital
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Kanagawa
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Kawasaki-shi, Kanagawa, Japan, 216-8511
- St Marianna University Hospital
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Sagamihara-shi, Kanagawa, Japan, 252-0392
- National Hospital Organization Sagamihara National Hospital
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Yokohama, Kanagawa, Japan, 224-8503
- Showa University Northern Yokohama Hospital
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Nagasaki
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Nagasaki, Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
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Osaka
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Habikino-shi, Osaka, Japan, 583-8588
- Osaka Habikino Medical Center
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Sakai-shi, Osaka, Japan, 593-8324
- Dermatology and Ophthalmology Kume Clinic
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 431-3192
- Hamamatsu University Hospital
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Tokyo
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Minato-ku, Tokyo, Japan, 108-0014
- Mita Dermatology Clinic
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Shinagawa-ku, Tokyo, Japan, 142-8666
- Showa University Hospital
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Shinjuku-ku, Tokyo, Japan, 161-8521
- Seibo International Catholic Hospital
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Toshima-ku, Tokyo, Japan, 170-0002
- Sugamo Kobayashi Derma Clinic
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Toyama
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Takaoka-shi, Toyama, Japan, 933-0871
- Shirasaki dermatology clinic
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Alberta
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Calgary, Alberta, Kanada, T3E 0B2
- Beacon Dermatology
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British Columbia
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Surrey, British Columbia, Kanada, V3R 6A7
- Doctor Chih-Ho Hong Medical Incorporated
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Ontario
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Etobicoke, Ontario, Kanada, M8X 1Y9
- Kingsway Clinical Research
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Markham, Ontario, Kanada, L3P 1X3
- Lynderm Research Inc
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Oakville, Ontario, Kanada, L6J 7W5
- The Centre for Clinical Trials Inc
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Peterborough, Ontario, Kanada, K9J 5K2
- SKiN Centre for Dermatology
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Richmond Hill, Ontario, Kanada, L4B 1A5
- The Centre for Dermatology
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Toronto, Ontario, Kanada, M4W 2N4
- Research Toronto
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Windsor, Ontario, Kanada, N8T 1E6
- XLR8 Medical Research, Incorporated
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Quebec
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Québec, Quebec, Kanada, G1V 4X7
- Centre de Recherche Dermatologique du Quebec metropolitain
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Sherbrooke, Quebec, Kanada, J1G 1X9
- Clinique Dermatologique de Sherbrooke
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Chihuahua City, Mexiko, 31203
- SCIENTIA Investigacion Clinica SC
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Cuautitlán Izcalli, Mexiko, 54750
- Phylasis Clínicas Research S. De R. L. De C. V.
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Michoacán
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Morelia, Michoacán, Mexiko, 58249
- Clinica de Enfermedades Crónicas y de Procedimientos Especiales
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Bialystok, Polen, 15-879
- ClinicMed Daniluk Nowak Spolka Komandytowa
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Chorzów, Polen, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
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Gdansk, Polen, 80-214
- Uniwersyteckie Centrum Kliniczne
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Krakow, Polen, 31-530
- Centermed krakow sp zoo
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Lodz, Polen, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Polen, 90-338
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
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Lodz, Polen, 91-495
- Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
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Lublin, Polen, 20-078
- Clinical Best Solutions Sp zoo Spolka komandytowa
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Poznan, Polen, 61-731
- Clinical Research Center Spzoo Medic-R Spolka Komandytowa
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Warsaw, Polen, 02-625
- Evimed sp zoo centrum medyczne evimed
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Almada, Portugal, 2801-951
- Hospital Garcia de Orta, EPE
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Coimbra, Portugal, 3000-075
- Centro Hospitalar e Universitário de Coimbra, EPE
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Lisbon, Portugal, 1998-018
- Hospital CUF Descobertas
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Porto, Portugal, 4099-001
- Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
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Porto, Portugal, 4200-319
- Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
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Bucharest, Rumänien, 020125
- Spitalul Clinic Colentina
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Stockholm, Schweden, 171 76
- Karolinska Universitetssjukhuset Solna
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Madrid, Spanien, 28034
- Hospital Universitario Ramón y Cajal
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Madrid, Spanien, 28046
- Hospital Universitario La Paz
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Majadahonda, Spanien, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Andalusia
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Seville, Andalusia, Spanien, 41009
- Hospital Universitario Virgen Macarena
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Navarre
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Pamplona, Navarre, Spanien, 31008
- Clinica Universidad de Navarra
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Valencia
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Alicante, Valencia, Spanien, 03010
- Hospital General Universitario de Alicante
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Manises, Valencia, Spanien, 46940
- Hospital de Manises
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Valencia, Valencia, Spanien, 46015
- Hospital Arnau de Vilanova de Valencia
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Durban, Südafrika, 3630
- Hiway Medical Centre
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Gauteng
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Centurion, Gauteng, Südafrika, 0157
- Ryexo Clinical Research
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Johannesburg, Gauteng, Südafrika, 2057
- About Allergy
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Ansansi, Gyeonggido, Südkorea, 15355
- Korea University Ansan Hospital
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Bucheon-si, Gyeonggi-do, Südkorea, 14584
- Soon Chun Hyang University Bucheon Hospital
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Busan, Südkorea, 49241
- Pusan National University Hospital
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Daegu, Südkorea, 41944
- Kyungpook National University Hospital
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Gwangju, Südkorea, 61453
- Chosun University Hospital
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Incheon, Südkorea, 22332
- Inha University Hospital
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Incheon, Südkorea, 21431
- The Catholic University of Korea Incheon St Marys Hospital
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Seongnam-si, Gyeonggi-do, Südkorea, 13620
- Seoul National University Bundang Hospital
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Seoul, Südkorea, 03080
- Seoul National University Hospital
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Seoul, Südkorea, 05505
- Asan Medical Center
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Seoul, Südkorea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Südkorea, 05278
- Kyung Hee University Hospital at Gangdong
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Seoul, Südkorea, 02841
- Korea University Anam Hospital
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Seoul, Südkorea, 05030
- Konkuk University Medical Center
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Seoul, Südkorea, 06973
- Chung-Ang University Hospital
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Seoul, Südkorea, 07441
- Hallym University Kangnam Sacred Heart Hospital
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Seoul, Südkorea, 04564
- National Medical Center
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Seoul, Südkorea, 07804
- Ewha Womans University Seoul Hospital
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Seoul, Südkorea, 06591
- The Catholic Univ of Korea Seoul St Marys Hospital
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Suwon-si, Gyeonggi-do, Südkorea, 16499
- Ajou University Hospital
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Kutná Hora, Tschechien, 284 01
- Kozni ambulance Kutna Hora sro
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Nový Jičín, Tschechien, 741 01
- Nemocnice Novy Jicin as
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Pardubice, Tschechien, 530 02
- CCR Czech as
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Pilsen, Tschechien, 305 99
- Fakultni Nemocnice Plzen
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Prague, Tschechien, 130 00
- CCR Prague sro
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Prague, Tschechien, 120 00
- Dermamedest sro
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Prague, Tschechien, 106 00
- Kozni ambulance Fialova sro
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Prague, Tschechien, 150 00
- Praglandia sro
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Svitavy, Tschechien, 568 02
- Dermatologicka ambulance MUDr Petr Trestik
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Ankara, Türkei (türkiye), 06230
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Gaziantep, Türkei (türkiye), 27310
- Gaziantep Universitesi Tip Fakultesi Hastanesi
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Istanbul, Türkei (türkiye), 34093
- Bezmialem Vakif Universitesi Hastanesi
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Izmir, Türkei (türkiye), 35620
- Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
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Kayseri, Türkei (türkiye), 38030
- Erciyes Universitesi Tip Fakultesi Hastanesi
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Kocaeli, Türkei (türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi Hastanesi
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Sakarya, Türkei (türkiye), 54050
- Sakarya Egitim ve Arastirma Hastanesi
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Arizona
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Litchfield Park, Arizona, Vereinigte Staaten, 85340
- Research Solutions of Arizona, PC
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Scottsdale, Arizona, Vereinigte Staaten, 85260
- Center for Dermatology and Plastic Surgery
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Arkansas
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Fayetteville, Arkansas, Vereinigte Staaten, 72703
- Clinical Trials Institute of Northwest Arkansas
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Hot Springs, Arkansas, Vereinigte Staaten, 71913
- Burke Pharmaceutical Research
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California
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Chula Vista, California, Vereinigte Staaten, 91911
- Velocity Clinical Research Chula Vista
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Dublin, California, Vereinigte Staaten, 94568
- West Coast Research LLC
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Encinitas, California, Vereinigte Staaten, 92024
- California Dermatology and Clinical Research Institute
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Fremont, California, Vereinigte Staaten, 94538
- Center for Dermatology Clinical Research Inc
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La Mesa, California, Vereinigte Staaten, 91942
- Velocity Clinical Research - San Diego
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North Hollywood, California, Vereinigte Staaten, 91606
- Velocity Clinical Research - North Hollywood
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Palmdale, California, Vereinigte Staaten, 93551
- Cura Clinical Research
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San Francisco, California, Vereinigte Staaten, 94115
- University of California at San Francisco, Dermatology Clinic at Mount Zion
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Santa Monica, California, Vereinigte Staaten, 90404
- Clinical Science Institute
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Colorado
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Castle Rock, Colorado, Vereinigte Staaten, 80109
- Clarity Dermatology
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Denver, Colorado, Vereinigte Staaten, 80209
- Velocity Clinical Research - Denver
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District of Columbia
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Washington D.C., District of Columbia, Vereinigte Staaten, 20016
- Foxhall Research Center
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Florida
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Cape Coral, Florida, Vereinigte Staaten, 33991
- Renaissance Research and Medical Group
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Coral Gables, Florida, Vereinigte Staaten, 33134
- Driven Research LLC
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Doral, Florida, Vereinigte Staaten, 33172
- Saint Jude Clinical Research
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Hialeah, Florida, Vereinigte Staaten, 33012
- Direct Helpers Research Center
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Margate, Florida, Vereinigte Staaten, 33063
- Glick Skin Institute
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Miami, Florida, Vereinigte Staaten, 33176
- Miami Dade Medical Research Institute, LLC
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Palmetto Bay, Florida, Vereinigte Staaten, 33157
- Innovation Medical Research Center Inc
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Tampa, Florida, Vereinigte Staaten, 33612
- University of South Florida Health Morsani Center for Advanced Healthcare
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Georgia
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Sandy Springs, Georgia, Vereinigte Staaten, 30328
- Advanced Medical Research Pc
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Illinois
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Normal, Illinois, Vereinigte Staaten, 61761
- Sneeze, Wheeze, and Itch Associates, LLC
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Indiana
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South Bend, Indiana, Vereinigte Staaten, 46617
- The South Bend Clinic LLP
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West Lafayette, Indiana, Vereinigte Staaten, 47906
- Options Research Group LLC
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Kansas
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Overland Park, Kansas, Vereinigte Staaten, 66223
- Dermatology and Skin Cancer Center of Overland Park
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Kentucky
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Louisville, Kentucky, Vereinigte Staaten, 40241
- DS Research
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Murray, Kentucky, Vereinigte Staaten, 42071
- Kentucky Advanced Medical Research LLC
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Massachusetts
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Brighton, Massachusetts, Vereinigte Staaten, 02135
- MetroBoston Clinical Partners
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Michigan
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Farmington Hills, Michigan, Vereinigte Staaten, 48334
- Wendy Sadoff MD Dermatology PC
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Troy, Michigan, Vereinigte Staaten, 48084
- Somerset Skin Centre
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Troy, Michigan, Vereinigte Staaten, 48084
- Revival Research Institute LLC
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Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68144
- Advanced Dermatology of the Midlands
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89117
- James Del Rosso Dermatology Research
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Reno, Nevada, Vereinigte Staaten, 89509
- Skin Cancer and Dermatology Institute
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New Hampshire
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Lebanon, New Hampshire, Vereinigte Staaten, 03766
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Riverdale, New Jersey, Vereinigte Staaten, 07457
- Weiss Medical
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New York
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Horseheads, New York, Vereinigte Staaten, 14845
- Corning Center for Clinical Research
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Kew Gardens, New York, Vereinigte Staaten, 11415
- Forest Hills Dermatology Group
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Monroe, New York, Vereinigte Staaten, 10950
- Crystal Run Healthcare
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New York, New York, Vereinigte Staaten, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, Vereinigte Staaten, 10022
- Ace Clinical Trials
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New York, New York, Vereinigte Staaten, 10128
- OptiSkin Medical
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The Bronx, New York, Vereinigte Staaten, 10467
- Montefiore Medical Center
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27713
- Duke South Durham
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45219
- University of Cincinnati
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Cincinnati, Ohio, Vereinigte Staaten, 45236
- Bernstein Clinical Research Center LLC
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Gahanna, Ohio, Vereinigte Staaten, 43230
- The Ohio State University Dermatology East
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Oregon
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Grants Pass, Oregon, Vereinigte Staaten, 97527
- Velocity Clinical Research - Grants Pass
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Portland, Oregon, Vereinigte Staaten, 97223
- Oregon Medical Research Center
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Rhode Island
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Warwick, Rhode Island, Vereinigte Staaten, 02886
- Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
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Texas
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Bellaire, Texas, Vereinigte Staaten, 77401
- Bellaire Dermatology Associates
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Cedar Park, Texas, Vereinigte Staaten, 78613
- US Dermatology Partners Cedar Park
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Dallas, Texas, Vereinigte Staaten, 75225
- Alina Clinical Trials, LLC
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Dallas, Texas, Vereinigte Staaten, 75230
- Zenos Clinical Research, LLC
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Houston, Texas, Vereinigte Staaten, 77030
- The University of Texas Health Science Center at Houston
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Houston, Texas, Vereinigte Staaten, 77037
- MedCare Pharma - Houston
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Lampasas, Texas, Vereinigte Staaten, 76550
- FMCScience LLC
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Lewisville, Texas, Vereinigte Staaten, 75057
- Epic Clinical Research Incorporated
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Missouri City, Texas, Vereinigte Staaten, 77459
- Sienna Dermatology Research
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San Antonio, Texas, Vereinigte Staaten, 78218
- Texas Dermatology and Laser Specialists
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San Antonio, Texas, Vereinigte Staaten, 78229
- Dermatology Clinical Research Center of San Antonio
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San Antonio, Texas, Vereinigte Staaten, 78229
- Andante Research
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Utah
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Murray, Utah, Vereinigte Staaten, 84107
- University of Utah Midvalley Dermatology
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Virginia
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Norfolk, Virginia, Vereinigte Staaten, 23507
- Eastern Virginia Medical School
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Washington
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Spokane, Washington, Vereinigte Staaten, 99202
- MultiCare Institute for Research and Innovation
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Corby, Vereinigtes Königreich, NN17 2UR
- Lakeside Healthcare
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London, Vereinigtes Königreich, SE1 9RT
- Guys Hospital
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Southampton, Vereinigtes Königreich, SO16 6YD
- Southampton General Hospital
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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 seit mindestens 6 Monaten bestehender AD-Diagnose gemäß AAD Consensus Criteria (2014).
- Anamnestisch unzureichendes Ansprechen auf TCS (topisches Kortikosteroid) mittlerer oder höherer Potenz innerhalb von 6 Monaten (mit oder ohne topische Calcineurin-Inhibitoren [TCI])
- EASI-Score ≥16
- vIGA-AD-Score ≥3
- ≥10 % Körperoberfläche (BSA) der AD-Beteiligung
- Schlimmste numerische Bewertungsskala für Pruritus ≥ 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:
- TCS jeder Potenz
- TCI
- Topische Phosphodiesterase-Typ-4-Hemmer
- 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: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Rocatinlimab
Rocatinlimab Dosis 1 alle 4 Wochen (Q4W) für 24 Wochen mit einer Aufsättigungsdosis in Woche 2.
|
Rocatinlimab wird durch eine subkutane (s.c.) Injektion verabreicht.
Andere Namen:
|
|
Placebo-Komparator: Placebo
Placebo Q4W für 24 Wochen mit einer Aufsättigungsdosis in Woche 2.
|
Das passende Placebo wird durch eine SC-Injektion verabreicht.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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," the participant met rIGA 0/1; if "No," they did not.
If vIGA-AD = 0, the participant met rIGA 0/1.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
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
|
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 ≥ 4-point Reduction From Baseline in Weekly Average of 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 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 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
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
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 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 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 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 AD.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD severity.
|
Baseline and Week 16
|
|
Change From Baseline in SCORAD Itch VAS Score at Week 24
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 more severe 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 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
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of 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 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
|
|
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 ≥ 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 daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
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
|
|
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Zeitfenster: Baseline and Week 24
|
Weekly average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours.
Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance.
Participants were asked to rate the intensity of their sleep disturbance using this scale each day.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in level of sleep disturbance.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
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
|
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.
Allgemeine Veröffentlichungen
- Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
- Guttman-Yassky E, Kabashima K, Worm M, Luna PC, Hong HC, Chovatiya R, Bernstein JA, Kern JS, Ehst BD, Magnolo N, Herranz-Pinto P, Stein Gold L, Sofen H, Pink AE, Esfandiari E, Arai T, Yang Y, Shi R, Barragan C, Kricorian G, Schwartz-Sagi L, Bissonnette R. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials. Lancet. 2026 Jan 3;407(10523):53-66. doi: 10.1016/S0140-6736(25)01865-3. Epub 2025 Nov 25.
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)
14. Dezember 2022
Primärer Abschluss (Tatsächlich)
5. Juni 2024
Studienabschluss (Tatsächlich)
27. August 2024
Studienanmeldedaten
Zuerst eingereicht
7. Dezember 2022
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. Dezember 2022
Zuerst gepostet (Tatsächlich)
15. Dezember 2022
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
26. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. Juni 2026
Zuletzt verifiziert
1. Mai 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
- Dermatologische Wirkstoffe
- KHK4083
Andere Studien-ID-Nummern
- 20210143
- 2022-501538-44 (Andere Kennung: EU CT Number)
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 und entweder 1) dem Produkt und der Indikation eine Marktzulassung in den USA und Europa erteilt wurden oder 2) die klinische Entwicklung für das Produkt und/oder die Indikation eingestellt 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
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .