Un estudio que evalúa rocatinlimab en combinación con corticosteroides tópicos y/o inhibidores de calcineurina tópicos en participantes adultos con dermatitis atópica (DA) de moderada a grave (ROCKET-SHUTTLE)
4 de agosto de 2026 actualizado por: Amgen
Estudio de fase 3, aleatorizado, de 24 semanas, controlado con placebo, doble ciego para evaluar la eficacia, seguridad y tolerabilidad de rocatinlimab (AMG 451) en combinación con corticosteroides tópicos y/o inhibidores de la calcineurina tópicos en sujetos adultos con Dermatitis atópica (DA) a severa (ROCKET-SHUTTLE)
Los objetivos coprincipales del estudio son:
- Evaluar la eficacia de rocatinlimab en combinación con corticosteroides tópicos y/o inhibidores de calcineurina tópicos (TCS/TCI), en comparación con placebo en combinación con TCS/TCI en la semana 24, evaluada mediante la Evaluación global del investigador validado para la dermatitis atópica (vIGA-AD) .
- Evaluar la eficacia de rocatinlimab, en combinación con TCS/TCI, en comparación con placebo en combinación con TCS/TCI en la semana 24, evaluada mediante el índice de gravedad y área de eccema (EASI).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
746
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Frankfurt am Main, Alemania, 60590
- Universitaetsklinikum Frankfurt
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Göttingen, Alemania, 37075
- Universitaetsmedizin Goettingen - Georg-August-Universitaet
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Hamburg, Alemania, 22391
- MensingDerma Research GmbH
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Hamburg, Alemania, 20537
- TFS Trial Form Support GmbH
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Hanover, Alemania, 30625
- Medizinische Hochschule Hannover
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Hanover, Alemania, 30159
- Hautaerzte Zentrum Hannover
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Mainz, Alemania, 55101
- Universitaetsmedizin Mainz
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Memmingen, Alemania, 87700
- Beldio Research Gmbh
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Merzing, Alemania, 66663
- Hautmedizin Saar
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München, Alemania, 80802
- Klinikum rechts der Isar der TUM
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
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La Plata, Buenos Aires, Argentina, B1902COS
- Framingham Centro Medico
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Ramos Mejía, Buenos Aires, Argentina, 1704
- DIM Clinica Privada
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Distrito Federal
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Buenos Aires, Distrito Federal, Argentina, 1121
- Fundacion CIDEA
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Buenos Aires, Distrito Federal, Argentina, 1054
- Buenos Aires Skin SA
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Buenos Aires, Distrito Federal, Argentina, 1414
- Care- Centro de Alergia y Enfermedades Respiratorias
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Buenos Aires, Distrito Federal, Argentina, 1425
- Psoriahue Medicina Interdisciplinaria SRL
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
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New South Wales
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Botany, New South Wales, Australia, 2019
- Emeritus Research Sydney
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital
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Queensland
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Benowa, Queensland, Australia, 4217
- The Skin Centre
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South Brisbane, Queensland, Australia, 4101
- Princess Alexandra Hospital
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Woolloongabba, Queensland, Australia, 4102
- Veracity Clinical Research
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Victoria
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Camberwell, Victoria, Australia, 3124
- Emeritus Research Melbourne
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Graz, Austria, 8036
- Medizinische Universitaet Graz
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Innsbruck, Austria, 6020
- Medizinische Universitaet Innsbruck
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Salzburg, Austria, 5020
- Landeskrankenhaus Salzburg
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Vienna, Austria, 1030
- Klinik Landstrasse
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Vienna, Austria, 1130
- Klinik Hietzing
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Dupnitsa, Bulgaria, 2600
- Medical Center Asklepii OOD
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Pleven, Bulgaria, 5800
- Medical center Medconsult Pleven OOD
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Sofia, Bulgaria, 1407
- Medical Center Excelsior OOD
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Sofia, Bulgaria, 1431
- Diagnostic-Consultative Center Alexandrovska EOOD
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Sofia, Bulgaria, 1463
- Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
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Bruges, Bélgica, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
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Brussels, Bélgica, 1090
- Universitair Ziekenhuis Brussel
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Brussels, Bélgica, 1020
- Centre Hospitalier Universitaire Brugmann
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Brussels, Bélgica, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Ghent, Bélgica, 9000
- Universitair Ziekenhuis Gent
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Herstal, Bélgica, 4040
- Clinique Andre Renard
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Kortrijk, Bélgica, 8500
- Dermatologie Handelskaai
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Leuven, Bélgica, 3000
- Universitaire Ziekenhuizen Leuven Gasthuisberg
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Liège, Bélgica, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
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Loverval, Bélgica, 6280
- Grand Hôpital de Charleroi
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Alberta
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Calgary, Alberta, Canadá, T2J 7E1
- Dermatology Research Institute Incorporated
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Edmonton, Alberta, Canadá, T5J 3S9
- Laser Rejuvenation Clinics Edmonton D T Incorporated
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Edmonton, Alberta, Canadá, T6G 1C3
- Alberta Derma Surgery Centre
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British Columbia
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Surrey, British Columbia, Canadá, V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg, Manitoba, Canadá, R3M 3Z4
- Wiseman Dermatology Research Incorporated
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Ontario
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Coburg, Ontario, Canadá, K9A 4J9
- Skin Health
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London, Ontario, Canadá, N6A 2C2
- Centricity Research London
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Newmarket, Ontario, Canadá, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
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Niagara Falls, Ontario, Canadá, L2H 1H5
- Allergy Research Canada Incorporated
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North Bay, Ontario, Canadá, P1B 3Z7
- North Bay Dermatology Centre
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Ottawa, Ontario, Canadá, K2C 3N2
- Dermatology Ottawa Research Centre
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Ottawa, Ontario, Canadá, K2C 3N2
- JRB Research Incorporated
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Richmond Hill, Ontario, Canadá, L4B 1A5
- The Centre for Dermatology
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Toronto, Ontario, Canadá, M2N 3A6
- North York Research Incorporated
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Toronto, Ontario, Canadá, M3H 5Y8
- Toronto Research Centre Inc
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Waterloo, Ontario, Canadá, N2J 1C4
- Alliance Clinical Trials
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Quebec
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Montreal, Quebec, Canadá, H2X 2V1
- Innovaderm Research Inc
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Montreal, Quebec, Canadá, H1Y 3L1
- Clinique de Dermatologie Rosemont
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Québec, Quebec, Canadá, G1W 4R4
- Centre de Recherche Saint-Louis
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Québec, Quebec, Canadá, G1V 4T3
- Diex Recherche Québec
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7T 0G3
- Saskatoon Dermatology Centre
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Bardejov, Eslovaquia, 085 01
- Maxderm, sro
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Bratislava, Eslovaquia, 813 69
- Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
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Prešov, Eslovaquia, 081 81
- Fakultna nemocnica s poliklinikou JA Reimana Presov
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Svidník, Eslovaquia, 089 01
- Sanare spol sro
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Ljubljana, Eslovenia, 1000
- Univerzitetni klinicni center Ljubljana
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Maribor, Eslovenia, 2000
- Univerzitetni Klinicni Center Maribor
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Madrid, España, 28041
- Hospital Universitario 12 de Octubre
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Pontevedra, España, 36001
- Complexo Hospitalario Universitario de Pontevedra
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Basque Country
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Bilbao, Basque Country, España, 48013
- Hospital Universitario Basurto
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Catalonia
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Barcelona, Catalonia, España, 08036
- Hospital Clinic i Provincial de Barcelona
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Valencia
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Valencia, Valencia, España, 46014
- Hospital General Universitario de Valencia
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- The University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Medical Dermatology Specialists
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Phoenix, Arizona, Estados Unidos, 85018
- Southwest Skin Specialists
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Sun City West, Arizona, Estados Unidos, 85375
- US Dermatology Partners Sun City West
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Arkansas
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North Little Rock, Arkansas, Estados Unidos, 72117
- Arkansas Research Trials, LLC
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California
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Bakersfield, California, Estados Unidos, 93301
- Kern Research Inc
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Los Angeles, California, Estados Unidos, 90056
- Wallace Medical Group Inc
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Los Angeles, California, Estados Unidos, 90033
- Keck Medicine of University of Southern California
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Palmdale, California, Estados Unidos, 93551
- Antelope Valley Clinical Trials
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Sacramento, California, Estados Unidos, 95816
- University of California at Davis Medical Center
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Sacramento, California, Estados Unidos, 95823
- Kaiser Permanente South Sacramento Medical Center
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San Diego, California, Estados Unidos, 92120
- Acclaim Clinical Research
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San Francisco, California, Estados Unidos, 94132
- Synergy Dermatology
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San Francisco, California, Estados Unidos, 94118
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Estados Unidos, 94118
- Kaiser Permanente Medical Center - San Francisco
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Florida
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Tampa, Florida, Estados Unidos, 33609
- TrueBlue Clinical Research
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Tampa, Florida, Estados Unidos, 33615
- Olympian Clinical Research - Tampa
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Georgia
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Alpharetta, Georgia, Estados Unidos, 30022
- Atlanta Dermatology, Vein and Research Center, PC
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Atlanta, Georgia, Estados Unidos, 30315
- Divine Dermatology and Aesthetics
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Illinois
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Skokie, Illinois, Estados Unidos, 60077
- Northshore University Healthsystem
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Indiana
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Clarksville, Indiana, Estados Unidos, 47129
- DS Research
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Indianapolis, Indiana, Estados Unidos, 46250
- Dawes Fretzin Clinical Research Group, LLC
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Kansas
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Leawood, Kansas, Estados Unidos, 66211
- Dermatology and Skin Cancer Center Leawood
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Louisiana
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Monroe, Louisiana, Estados Unidos, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
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Maryland
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Rockville, Maryland, Estados Unidos, 20850
- Aesthetic and Dermatology Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Medical Center
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Auburn Hills, Michigan, Estados Unidos, 48326
- Oakland Hills Dermatology
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68505
- Somnos Clinical Research
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Omaha, Nebraska, Estados Unidos, 68144
- Skin Specialists PC
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89119
- Vivida Dermatology
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North Las Vegas, Nevada, Estados Unidos, 89030
- Las Vegas Clinical Trials
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Schweiger Dermatology Group, PC Research Division
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87102
- Albuquerque Clinical Trials Incorporated
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New York
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The Bronx, New York, Estados Unidos, 10455
- CHEAR Center LLC
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North Carolina
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Wilmington, North Carolina, Estados Unidos, 28401
- Accellacare of Wilmington
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Ohio
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Bexley, Ohio, Estados Unidos, 43209
- Bexley Dermatology Research
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Oregon
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Medford, Oregon, Estados Unidos, 97504
- Velocity Clinical Research Inc
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19103
- Paddington Testing Company Inc
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57702
- Health Concepts
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Texas
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Austin, Texas, Estados Unidos, 78759
- US Dermatology Partners Jollyville
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El Paso, Texas, Estados Unidos, 79925
- Newco 3A Research LLC
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Kerrville, Texas, Estados Unidos, 78028
- Sante Clinical Research
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Plano, Texas, Estados Unidos, 75025
- Texas Dermatology Research Center
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
- Virginia Dermatology and Skin Cancer Center
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Antony, Francia, 92160
- Hopital Prive d Antony
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Bordeaux, Francia, Cedex
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
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Brest, Francia, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
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Lille, Francia, 59037
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
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Lorient, Francia, 56322
- Centre Hospitalier de Bretagne Sud - Hopital du Scorff
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Marseille, Francia, 13385
- Hôpital La Timone
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Martigues, Francia, 13500
- Cabinet du Docteur Ruer-Mulard Mireille
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Nantes, Francia, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
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Nice, Francia, 06202
- Centre Hospitalier Universitaire Archet 2
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Paris, Francia, 75020
- Hôpital Tenon
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Paris, Francia, 75475
- Hopital Saint Louis
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Paris, Francia, 75018
- Hopital Bichat Claude Bernard
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Reims, Francia, 51100
- Polyclinique de Courlancy
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Rennes, Francia, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Rouen, Francia, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
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Saint-Priest-en-Jarez, Francia, 42270
- Centre Hospitalier Universitaire Saint Etienne Hopital Nord
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Toulon, Francia, 83800
- Hopital d instruction des armees sainte anne
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Athens, Grecia, 11525
- 401 General Military Hospital Of Athens
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Athens, Grecia, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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Heraklion, Grecia, 71500
- University General Hospital of Heraklion
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Nea Ionia, Grecia, 14233
- General Hospital Of Nea Ionia Konstantopouleio Patision
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Piraeus, Grecia, 18536
- Geniko Nosokomeio Peiraia Tzaneio
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Thessaloniki, Grecia, 54642
- Ippokratio General Hospital of Thessaloniki
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Budapest, Hungría, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, Hungría, 1027
- Csalogany Orvosi Kozpont
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Budapest, Hungría, 1033
- Clinexpert Kft
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Békéscsaba, Hungría, 5600
- Trial Pharma Kft
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Debrecen, Hungría, 4032
- Debreceni Egyetem Klinikai Kozpont
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Gyöngyös, Hungría, 3200
- Gyongyosi Bugat Pal Korhaz
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Kaposvár, Hungría, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Orosháza, Hungría, 5900
- DermaMed Research Kft
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Szolnok, Hungría, 5000
- Allergo-Derm Bakos Kft
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Zalaegerszeg, Hungría, 8900
- Obudai Egeszsegugyi Centrum Kft
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Genova, Italia, 16132
- Ospedale Policlinico San Martino IRCCS
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LAquila, Italia, 67100
- Ospedale San Salvatore
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Roma, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Rozzano MI, Italia, 20089
- IRCCS Istituto Clinico Humanitas
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Aichi-ken
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Nagoya, Aichi-ken, Japón, 454-0803
- Fukui Dermatology Clinic
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Fukuoka
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Fukuoka, Fukuoka, Japón, 812-0013
- Ekihigashi Dermatology Allergy Clinic
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Hokkaido
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Obihiro-shi, Hokkaido, Japón, 080-0013
- Takagi Dermatological Clinic Branch
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Sapporo, Hokkaido, Japón, 060-0063
- Medical Corporation Kojinkai Sapporo Skin Clinic
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japón, 890-0063
- Katahira Dermatology Urology Clinic
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Kanagawa
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Kawasaki-shi, Kanagawa, Japón, 211-0063
- Kosugi Dermatology Clinic
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Yokohama, Kanagawa, Japón, 221-0825
- Nomura Dermatology Clinic
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Kumamoto
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Kumamoto, Kumamoto, Japón, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
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Kumamoto, Kumamoto, Japón, 862-0950
- Suizenji Dermatology Clinic
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Osaka
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Neyagawa, Osaka, Japón, 572-0838
- Yoshioka Dermatology Clinic
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Shizuoka
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Hamamatsu, Shizuoka, Japón, 430-0929
- JA Shizuoka Kohseiren Enshu Hospital
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Tokyo
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Adachi-ku, Tokyo, Japón, 120-0034
- Mildix Skin Clinic
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Setagaya-ku, Tokyo, Japón, 158-0097
- Naoko Dermatology Clinic
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Shinagawa-ku, Tokyo, Japón, 141-8625
- NTT Medical Center Tokyo
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Shinjuku-ku, Tokyo, Japón, 169-0075
- Yamate Dermatology Clinic
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Johor
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Johor Bahru, Johor, Malasia, 81100
- Hospital Sultan Ismail
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malasia, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malasia, 59100
- University Malaya Medical Centre
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Kuala Lumpur, Kuala Lumpur, Malasia, 56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
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Perak
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Ipoh, Perak, Malasia, 30450
- Hospital Raja Permaisuri Bainun
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Pulau Pinang
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George Town, Pulau Pinang, Malasia, 10990
- Hospital Pulau Pinang
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Sabah
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Kota Kinabalu, Sabah, Malasia, 88586
- Queen Elizabeth Hospital
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Bergen op Zoom, Países Bajos, 4624 VT
- Bravis Ziekenhuis
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Groningen, Países Bajos, 9700 RB
- Universitair Medisch Centrum Groningen
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Utrecht, Países Bajos, 3584 CX
- Universitair Medisch Centrum Utrecht
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Chorzów, Polonia, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
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Katowice, Polonia, 40-600
- GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
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Krakow, Polonia, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
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Lodz, Polonia, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Polonia, 90-752
- Ip Clinic Sp zoo
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Szczecin, Polonia, 71-500
- Twoja Przychodnia SCM
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Wroclaw, Polonia, 51-503
- DermMedica Spzoo Centrum Columbus
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Beijing, Porcelana, 100044
- Peking University Peoples Hospital
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Shanghai, Porcelana, 200443
- Shanghai Skin Disease Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, Porcelana, 100050
- Beijing Friendship hospital, Capital Medical University
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Fujian
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Fuzhou, Fujian, Porcelana, 350000
- The First Affiliated Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510091
- Dermatology Hospital of Southern Medical University
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Guangzhou, Guangdong, Porcelana, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
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Guangzhou, Guangdong, Porcelana, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
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Shantou, Guangdong, Porcelana, 515041
- The Fist Affiliated Hospital of Shantou University Medical College
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Shenzhen, Guangdong, Porcelana, 518101
- Shenzhen Qianhai Shekou Free Trade Zone Hospital
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Henan
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Nanyang, Henan, Porcelana, 473002
- Nanyang First Peoples Hospital
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Hubei
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Wuhan, Hubei, Porcelana, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Jiangsu
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Wuxi, Jiangsu, Porcelana, 214001
- Wuxi Second Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330000
- Dermatology Hospital of Jiangxi Province
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Jilin
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Changchun, Jilin, Porcelana, 130021
- The First Hospital of Jilin University
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Sichuan
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Chengdu, Sichuan, Porcelana, 610017
- Chengdu Second Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Porcelana, 310016
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Porcelana, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
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Ningbo, Zhejiang, Porcelana, 315010
- The First Affiliation Hospital Of Ningbo University
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Taizhou, Zhejiang, Porcelana, 318000
- Taizhou Central Hospital
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Caguas, Puerto Rico, 00727-9507
- Doctor Samuel Sanchez PSC
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Bath, Reino Unido, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
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Dudley, Reino Unido, DY1 2HQ
- Russells Hall Hospital
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Isleworth, Reino Unido, TW7 6AF
- West Middlesex University Hospital
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London, Reino Unido, NW3 2PF
- The Royal Free Hospital
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Salford, Reino Unido, M6 8HD
- Salford Care Organisation
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Shipley, Reino Unido, BD18 3SA
- Accellacare Yorkshire
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Brasov, Rumania, 500112
- Theramed Healthcare SRL
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Cluj-Napoca, Rumania, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
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Târgu Mureş, Rumania, 540613
- Spitalul Clinic Judetean Mures
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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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Bern, Suiza, 3010
- Inselspital Bern
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Geneva, Suiza, 1211
- Hopitaux Universitaires de Geneve
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Lausanne, Suiza, 1011
- Centre Hospitalier Universitaire Vaudois
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Sankt Gallen, Suiza, 9007
- Kantonsspital Sankt Gallen
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Zurich, Suiza, 8091
- Universitaetsspital Zuerich
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Ankara, Turquía (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
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Istanbul, Turquía (Türkiye), 34390
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
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Istanbul, Turquía (Türkiye), 34662
- Acibadem Altunizade Hastanesi
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Istanbul, Turquía (Türkiye), 34899
- Marmara Universitesi Tip Fakultesi Hastanesi
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Samsun, Turquía (Türkiye), 55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 100 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Edad ≥ 18 años con diagnóstico de DA según los Consensus Criteria de la AAD (American Academy of Dermatology) (2014) presente durante al menos 6 meses
- Historial de respuesta inadecuada a TCS de potencia media o alta dentro de los 6 meses (con o sin TCI)
- Puntuación EASI ≥16
- Puntuación vIGA-AD ≥3
- ≥10% del área de superficie corporal (BSA) de compromiso de AD
- Escala de calificación numérica del peor prurito ≥ 4
Criterio de exclusión:
- Tratamiento con un producto biológico dentro de las 12 semanas o 5 semividas, lo que sea más largo, antes del Día 1
Tratamiento con cualquiera de los siguientes medicamentos o terapias dentro de las 4 semanas o 5 semividas, lo que sea más largo, antes del Día 1:
- corticosteroides sistémicos
- Inmunosupresores sistémicos
- Fototerapia
- Inhibidores de la cinasa Janus
Tratamiento con cualquiera de los siguientes medicamentos o terapias dentro de 1 semana, antes del Día 1:
- TCS
- TCI
- Agentes antipruriginosos
- Inhibidores tópicos de la fosfodiesterasa tipo 4
- Otros agentes inmunosupresores tópicos
- Combinación de agentes tópicos que incluyen TCS de cualquier potencia o TCI, inhibidores de PDE4 u otros agentes inmunosupresores tópicos
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Rocatinlimab Dosis 1 + TCS/TCI
Rocatinlimab Dosis 1 cada 4 semanas (Q4W) durante 24 semanas + TCS/TCI + dosis de carga en la Semana 2.
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Inyección subcutánea (SC)
Otros nombres:
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Experimental: Rocatinlimab Dosis 2 + TCS/TCI
Rocatinlimab dosis 2 Q4W durante 24 semanas + TCS/TCI + dosis de carga en la semana 2.
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Inyección subcutánea (SC)
Otros nombres:
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Comparador de placebos: Placebo + TCS/TCI
Placebo Q4W durante 24 semanas + TCS/TCI + dosis de carga en la Semana 2.
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Inyección SC
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Periodo de tiempo: Baseline and Week 24
|
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
|
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Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (vIGA-AD) 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
Periodo de tiempo: Baseline and Week 24
|
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity.
Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'.
For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?"
If "Yes," participant met rIGA 0/1; if "No," they did not.
If vIGA-AD = 0, participant met rIGA 0/1.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Periodo de tiempo: Baseline and Week 16
|
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 16
|
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Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (vIGA-AD 0/1) at Week 16
Periodo de tiempo: Baseline and Week 16
|
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe.
Higher scores indicated greater disease severity.
Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 16
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Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Periodo de tiempo: Baseline and Week 16
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The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 16
|
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Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Periodo de tiempo: Baseline and Week 24
|
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Periodo de tiempo: Baseline and Week 24
|
The EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
|
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Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) With a ≥ 2-Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
Periodo de tiempo: Baseline and Week 24
|
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe.
Higher scores indicated greater disease severity.
Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
Periodo de tiempo: Baseline and Week 24
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The severity of facial AD was assessed using the Facial AD Severity Scale (FASS).
The FASS was an instrument used to rate the overall severity of facial AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline
Periodo de tiempo: Baseline and Week 24
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The severity of hand AD was assessed using the Hand Atopic Dermatitis Severity Scale (HASS).
The HASS was an instrument used to rate the overall severity of hand AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
Periodo de tiempo: 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.
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Baseline and Week 24
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Change From Baseline in DLQI Score at Week 24
Periodo de tiempo: Baseline and Week 24
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The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adult patients suffering from skin disease.
The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
Periodo de tiempo: Baseline and Week 24
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The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD.
It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
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Change From Baseline in POEM Score at Week 24
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Periodo de tiempo: 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
|
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Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Periodo de tiempo: 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.
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Baseline and Week 24
|
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Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Periodo de tiempo: 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
Periodo de tiempo: Baseline and Week 24
|
The worst pruritus score was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in itch intensity.
|
Baseline and Week 24
|
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Change From Baseline in SCORAD Itch VAS Score at Week 24
Periodo de tiempo: 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
|
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Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Periodo de tiempo: Baseline and Week 16
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AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 16
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Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Periodo de tiempo: Baseline and Week 24
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AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Periodo de tiempo: Baseline and Week 16
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AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 16
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: MD, Amgen
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
21 de febrero de 2023
Finalización primaria (Actual)
15 de septiembre de 2024
Finalización del estudio (Actual)
4 de diciembre de 2024
Fechas de registro del estudio
Enviado por primera vez
2 de febrero de 2023
Primero enviado que cumplió con los criterios de control de calidad
2 de febrero de 2023
Publicado por primera vez (Actual)
13 de febrero de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Genéticas Congénitas
- Enfermedades del sistema inmunológico
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Enfermedades de la piel
- Enfermedades De La Piel Genéticas
- Enfermedades De La Piel Eccematosas
- Dermatitis
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades de la piel y del tejido conectivo
- Dermatitis Atópica
- Eczema
Otros números de identificación del estudio
- 20210144
- 2022-501585-22-00 (Identificador de registro: CTIS (EU))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Datos de pacientes individuales desidentificados para las variables necesarias para abordar la pregunta de investigación específica en una solicitud de intercambio de datos aprobada.
Marco de tiempo para compartir IPD
Las solicitudes de intercambio de datos relacionadas con este estudio se considerarán a partir de los 18 meses posteriores a la finalización del estudio y 1) el producto y la indicación han obtenido la autorización de comercialización tanto en los EE. UU. como en Europa o 2) el desarrollo clínico del producto y/o la indicación se interrumpe y los datos no se enviarán a las autoridades reguladoras.
No hay una fecha límite para la elegibilidad para enviar una solicitud de intercambio de datos para este estudio.
Criterios de acceso compartido de IPD
Los investigadores calificados pueden enviar una solicitud que contenga los objetivos de la investigación, los productos de Amgen y el alcance de los estudios de Amgen, los criterios de valoración/resultados de interés, el plan de análisis estadístico, los requisitos de datos, el plan de publicación y las calificaciones de los investigadores.
En general, Amgen no concede solicitudes externas de datos de pacientes individuales con el fin de reevaluar los problemas de seguridad y eficacia ya abordados en la etiqueta del producto.
Las solicitudes son revisadas por un comité de asesores internos.
Si no se aprueba, un Panel de Revisión Independiente de Intercambio de Datos arbitrará y tomará la decisión final.
Tras la aprobación, la información necesaria para abordar la pregunta de investigación se proporcionará bajo los términos de un acuerdo de intercambio de datos.
Esto puede incluir datos de pacientes individuales anonimizados y/o documentos de respaldo disponibles, que contengan fragmentos de código de análisis donde se proporcione en las especificaciones de análisis.
Más detalles están disponibles en la siguiente URL.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .