En undersøgelse, der vurderer rocatinlimab i kombination med topiske kortikosteroider og/eller topiske calcineurinhæmmere hos voksne deltagere med moderat til svær atopisk dermatitis (AD) (ROCKET-SHUTTLE)
4. august 2026 opdateret af: Amgen
Et fase 3, randomiseret, 24-ugers, placebokontrolleret, dobbeltblindt studie for at vurdere effektiviteten, sikkerheden og tolerabiliteten af Rocatinlimab (AMG 451) i kombination med topiske kortikosteroider og/eller topiske calcineurinhæmmere hos voksne patienter med moderat- til svær atopisk dermatitis (AD) (ROCKET-SHUTTLE)
De primære mål med undersøgelsen er at:
- For at evaluere effekten af rocatinlimab i kombination med topisk kortikosteroid og/eller topisk calcineurinhæmmer (TCS/TCI) sammenlignet med placebo i kombination med TCS/TCI i uge 24, vurderet ved hjælp af Validated Investigators Global Assessment for Atopisk Dermatitis (vIGA-AD) .
- For at evaluere effekten af rocatinlimab i kombination med TCS/TCI sammenlignet med placebo i kombination med TCS/TCI i uge 24, vurderet ved hjælp af Eczema Area and Severity Index (EASI).
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
746
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Amgen Call Center
- Telefonnummer: 866-572-6436
- E-mail: medinfo@amgen.com
Studiesteder
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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, Australien, 2019
- Emeritus Research Sydney
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Westmead, New South Wales, Australien, 2145
- Westmead Hospital
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Queensland
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Benowa, Queensland, Australien, 4217
- The Skin Centre
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South Brisbane, Queensland, Australien, 4101
- Princess Alexandra Hospital
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Woolloongabba, Queensland, Australien, 4102
- Veracity Clinical Research
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Victoria
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Camberwell, Victoria, Australien, 3124
- Emeritus Research Melbourne
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Bruges, Belgien, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
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Brussels, Belgien, 1090
- Universitair Ziekenhuis Brussel
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Brussels, Belgien, 1020
- Centre Hospitalier Universitaire Brugmann
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Brussels, Belgien, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Ghent, Belgien, 9000
- Universitair Ziekenhuis Gent
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Herstal, Belgien, 4040
- Clinique Andre Renard
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Kortrijk, Belgien, 8500
- Dermatologie Handelskaai
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Leuven, Belgien, 3000
- Universitaire Ziekenhuizen Leuven Gasthuisberg
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Liège, Belgien, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
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Loverval, Belgien, 6280
- Grand Hôpital de Charleroi
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Dupnitsa, Bulgarien, 2600
- Medical Center Asklepii OOD
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Pleven, Bulgarien, 5800
- Medical center Medconsult Pleven OOD
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Sofia, Bulgarien, 1407
- Medical Center Excelsior OOD
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Sofia, Bulgarien, 1431
- Diagnostic-Consultative Center Alexandrovska EOOD
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Sofia, Bulgarien, 1463
- Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
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Alberta
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Calgary, Alberta, Canada, T2J 7E1
- Dermatology Research Institute Incorporated
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Edmonton, Alberta, Canada, T5J 3S9
- Laser Rejuvenation Clinics Edmonton D T Incorporated
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Edmonton, Alberta, Canada, T6G 1C3
- Alberta Derma Surgery Centre
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British Columbia
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Surrey, British Columbia, Canada, V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg, Manitoba, Canada, R3M 3Z4
- Wiseman Dermatology Research Incorporated
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Ontario
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Coburg, Ontario, Canada, K9A 4J9
- Skin Health
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London, Ontario, Canada, N6A 2C2
- Centricity Research London
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Newmarket, Ontario, Canada, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
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Niagara Falls, Ontario, Canada, L2H 1H5
- Allergy Research Canada Incorporated
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North Bay, Ontario, Canada, P1B 3Z7
- North Bay Dermatology Centre
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Ottawa, Ontario, Canada, K2C 3N2
- Dermatology Ottawa Research Centre
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Ottawa, Ontario, Canada, K2C 3N2
- JRB Research Incorporated
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Richmond Hill, Ontario, Canada, L4B 1A5
- The Centre for Dermatology
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Toronto, Ontario, Canada, M2N 3A6
- North York Research Incorporated
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Toronto, Ontario, Canada, M3H 5Y8
- Toronto Research Centre Inc
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Waterloo, Ontario, Canada, N2J 1C4
- Alliance Clinical Trials
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Quebec
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Montreal, Quebec, Canada, H2X 2V1
- Innovaderm Research Inc
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Montreal, Quebec, Canada, H1Y 3L1
- Clinique de Dermatologie Rosemont
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Québec, Quebec, Canada, G1W 4R4
- Centre de Recherche Saint-Louis
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Québec, Quebec, Canada, G1V 4T3
- Diex Recherche Québec
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7T 0G3
- Saskatoon Dermatology Centre
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Bath, Det Forenede Kongerige, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
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Dudley, Det Forenede Kongerige, DY1 2HQ
- Russells Hall Hospital
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Isleworth, Det Forenede Kongerige, TW7 6AF
- West Middlesex University Hospital
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London, Det Forenede Kongerige, NW3 2PF
- The Royal Free Hospital
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Salford, Det Forenede Kongerige, M6 8HD
- Salford Care Organisation
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Shipley, Det Forenede Kongerige, BD18 3SA
- Accellacare Yorkshire
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- The University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006
- Medical Dermatology Specialists
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Phoenix, Arizona, Forenede Stater, 85018
- Southwest Skin Specialists
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Sun City West, Arizona, Forenede Stater, 85375
- US Dermatology Partners Sun City West
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Arkansas
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North Little Rock, Arkansas, Forenede Stater, 72117
- Arkansas Research Trials, LLC
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California
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Bakersfield, California, Forenede Stater, 93301
- Kern Research Inc
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Los Angeles, California, Forenede Stater, 90056
- Wallace Medical Group Inc
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Los Angeles, California, Forenede Stater, 90033
- Keck Medicine of University of Southern California
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Palmdale, California, Forenede Stater, 93551
- Antelope Valley Clinical Trials
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Sacramento, California, Forenede Stater, 95816
- University of California at Davis Medical Center
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Sacramento, California, Forenede Stater, 95823
- Kaiser Permanente South Sacramento Medical Center
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San Diego, California, Forenede Stater, 92120
- Acclaim Clinical Research
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San Francisco, California, Forenede Stater, 94132
- Synergy Dermatology
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San Francisco, California, Forenede Stater, 94118
- Kaiser Permanente Medical Center - Oakland
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San Francisco, California, Forenede Stater, 94118
- Kaiser Permanente Medical Center - San Francisco
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Florida
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Tampa, Florida, Forenede Stater, 33609
- TrueBlue Clinical Research
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Tampa, Florida, Forenede Stater, 33615
- Olympian Clinical Research - Tampa
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Georgia
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Alpharetta, Georgia, Forenede Stater, 30022
- Atlanta Dermatology, Vein and Research Center, PC
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Atlanta, Georgia, Forenede Stater, 30315
- Divine Dermatology and Aesthetics
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Illinois
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Skokie, Illinois, Forenede Stater, 60077
- Northshore University Healthsystem
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Indiana
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Clarksville, Indiana, Forenede Stater, 47129
- DS Research
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Indianapolis, Indiana, Forenede Stater, 46250
- Dawes Fretzin Clinical Research Group, LLC
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Kansas
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Leawood, Kansas, Forenede Stater, 66211
- Dermatology and Skin Cancer Center Leawood
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Louisiana
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Monroe, Louisiana, Forenede Stater, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
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Maryland
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Rockville, Maryland, Forenede Stater, 20850
- Aesthetic and Dermatology Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Medical Center
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Auburn Hills, Michigan, Forenede Stater, 48326
- Oakland Hills Dermatology
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68505
- Somnos Clinical Research
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Omaha, Nebraska, Forenede Stater, 68144
- Skin Specialists PC
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89119
- Vivida Dermatology
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North Las Vegas, Nevada, Forenede Stater, 89030
- Las Vegas Clinical Trials
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Schweiger Dermatology Group, PC Research Division
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- Albuquerque Clinical Trials Incorporated
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New York
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The Bronx, New York, Forenede Stater, 10455
- CHEAR Center LLC
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North Carolina
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Wilmington, North Carolina, Forenede Stater, 28401
- Accellacare of Wilmington
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Ohio
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Bexley, Ohio, Forenede Stater, 43209
- Bexley Dermatology Research
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Oregon
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Medford, Oregon, Forenede Stater, 97504
- Velocity Clinical Research Inc
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19103
- Paddington Testing Company Inc
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Medical Center
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57702
- Health Concepts
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Texas
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Austin, Texas, Forenede Stater, 78759
- US Dermatology Partners Jollyville
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El Paso, Texas, Forenede Stater, 79925
- Newco 3A Research LLC
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Kerrville, Texas, Forenede Stater, 78028
- Sante Clinical Research
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Plano, Texas, Forenede Stater, 75025
- Texas Dermatology Research Center
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Virginia
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Norfolk, Virginia, Forenede Stater, 23502
- Virginia Dermatology and Skin Cancer Center
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Antony, Frankrig, 92160
- Hopital Prive d Antony
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Bordeaux, Frankrig, Cedex
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
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Brest, Frankrig, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
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Lille, Frankrig, 59037
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
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Lorient, Frankrig, 56322
- Centre Hospitalier de Bretagne Sud - Hopital du Scorff
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Marseille, Frankrig, 13385
- Hôpital La Timone
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Martigues, Frankrig, 13500
- Cabinet du Docteur Ruer-Mulard Mireille
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Nantes, Frankrig, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
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Nice, Frankrig, 06202
- Centre Hospitalier Universitaire Archet 2
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Paris, Frankrig, 75020
- Hôpital Tenon
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Paris, Frankrig, 75475
- Hopital Saint Louis
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Paris, Frankrig, 75018
- Hopital Bichat Claude Bernard
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Reims, Frankrig, 51100
- Polyclinique de Courlancy
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Rennes, Frankrig, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Rouen, Frankrig, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
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Saint-Priest-en-Jarez, Frankrig, 42270
- Centre Hospitalier Universitaire Saint Etienne Hopital Nord
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Toulon, Frankrig, 83800
- Hopital d instruction des armees sainte anne
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Athens, Grækenland, 11525
- 401 General Military Hospital Of Athens
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Athens, Grækenland, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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Heraklion, Grækenland, 71500
- University General Hospital of Heraklion
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Nea Ionia, Grækenland, 14233
- General Hospital Of Nea Ionia Konstantopouleio Patision
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Piraeus, Grækenland, 18536
- Geniko Nosokomeio Peiraia Tzaneio
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Thessaloniki, Grækenland, 54642
- Ippokratio General Hospital of Thessaloniki
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Bergen op Zoom, Holland, 4624 VT
- Bravis Ziekenhuis
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Groningen, Holland, 9700 RB
- Universitair Medisch Centrum Groningen
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Utrecht, Holland, 3584 CX
- Universitair Medisch Centrum Utrecht
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Genova, Italien, 16132
- Ospedale Policlinico San Martino IRCCS
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LAquila, Italien, 67100
- Ospedale San Salvatore
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Roma, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Rozzano MI, Italien, 20089
- IRCCS Istituto Clinico Humanitas
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 454-0803
- Fukui Dermatology Clinic
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Fukuoka
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Fukuoka, Fukuoka, Japan, 812-0013
- Ekihigashi Dermatology Allergy Clinic
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Hokkaido
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Obihiro-shi, Hokkaido, Japan, 080-0013
- Takagi Dermatological Clinic Branch
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Sapporo, Hokkaido, Japan, 060-0063
- Medical Corporation Kojinkai Sapporo Skin Clinic
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japan, 890-0063
- Katahira Dermatology Urology Clinic
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Kanagawa
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Kawasaki-shi, Kanagawa, Japan, 211-0063
- Kosugi Dermatology Clinic
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Yokohama, Kanagawa, Japan, 221-0825
- Nomura Dermatology Clinic
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Kumamoto
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Kumamoto, Kumamoto, Japan, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
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Kumamoto, Kumamoto, Japan, 862-0950
- Suizenji Dermatology Clinic
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Osaka
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Neyagawa, Osaka, Japan, 572-0838
- Yoshioka Dermatology Clinic
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 430-0929
- JA Shizuoka Kohseiren Enshu Hospital
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Tokyo
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Adachi-ku, Tokyo, Japan, 120-0034
- Mildix Skin Clinic
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Setagaya-ku, Tokyo, Japan, 158-0097
- Naoko Dermatology Clinic
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Shinagawa-ku, Tokyo, Japan, 141-8625
- NTT Medical Center Tokyo
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Shinjuku-ku, Tokyo, Japan, 169-0075
- Yamate Dermatology Clinic
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Beijing, Kina, 100044
- Peking University Peoples Hospital
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Shanghai, Kina, 200443
- Shanghai Skin Disease Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, Kina, 100050
- Beijing Friendship hospital, Capital Medical University
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Fujian
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Fuzhou, Fujian, Kina, 350000
- The First Affiliated Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, Kina, 510091
- Dermatology Hospital of Southern Medical University
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Guangzhou, Guangdong, Kina, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
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Guangzhou, Guangdong, Kina, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
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Shantou, Guangdong, Kina, 515041
- The Fist Affiliated Hospital of Shantou University Medical College
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Shenzhen, Guangdong, Kina, 518101
- Shenzhen Qianhai Shekou Free Trade Zone Hospital
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Henan
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Nanyang, Henan, Kina, 473002
- Nanyang First Peoples Hospital
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Hubei
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Wuhan, Hubei, Kina, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Jiangsu
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Wuxi, Jiangsu, Kina, 214001
- Wuxi Second Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, Kina, 330000
- Dermatology Hospital of Jiangxi Province
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Jilin
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Changchun, Jilin, Kina, 130021
- The First Hospital of Jilin University
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Sichuan
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Chengdu, Sichuan, Kina, 610017
- Chengdu Second Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Kina, 310016
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Kina, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
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Ningbo, Zhejiang, Kina, 315010
- The First Affiliation Hospital Of Ningbo University
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Taizhou, Zhejiang, Kina, 318000
- Taizhou Central Hospital
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Johor
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Johor Bahru, Johor, Malaysia, 81100
- Hospital Sultan Ismail
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
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Perak
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Ipoh, Perak, Malaysia, 30450
- Hospital Raja Permaisuri Bainun
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Pulau Pinang
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George Town, Pulau Pinang, Malaysia, 10990
- Hospital Pulau Pinang
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Sabah
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Kota Kinabalu, Sabah, Malaysia, 88586
- Queen Elizabeth Hospital
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-
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Chorzów, Polen, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
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Katowice, Polen, 40-600
- GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
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Krakow, Polen, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
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Lodz, Polen, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Polen, 90-752
- Ip Clinic Sp zoo
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Szczecin, Polen, 71-500
- Twoja Przychodnia SCM
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Wroclaw, Polen, 51-503
- DermMedica Spzoo Centrum Columbus
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-
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Caguas, Puerto Rico, 00727-9507
- Doctor Samuel Sanchez PSC
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-
-
-
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Brasov, Rumænien, 500112
- Theramed Healthcare SRL
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Cluj-Napoca, Rumænien, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
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Târgu Mureş, Rumænien, 540613
- Spitalul Clinic Judetean Mures
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-
-
-
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Bern, Schweiz, 3010
- Inselspital Bern
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Geneva, Schweiz, 1211
- Hopitaux Universitaires de Geneve
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Lausanne, Schweiz, 1011
- Centre Hospitalier Universitaire Vaudois
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Sankt Gallen, Schweiz, 9007
- Kantonsspital Sankt Gallen
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Zurich, Schweiz, 8091
- Universitaetsspital Zuerich
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-
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-
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Singapore, Singapore, 308205
- National Skin Centre
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Singapore, Singapore, 168753
- Singapore General Hospital
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Singapore, Singapore, 117599
- National University Hospital
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-
-
-
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Bardejov, Slovakiet, 085 01
- Maxderm, sro
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Bratislava, Slovakiet, 813 69
- Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
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Prešov, Slovakiet, 081 81
- Fakultna nemocnica s poliklinikou JA Reimana Presov
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Svidník, Slovakiet, 089 01
- Sanare spol sro
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-
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-
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Ljubljana, Slovenien, 1000
- Univerzitetni klinicni center Ljubljana
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Maribor, Slovenien, 2000
- Univerzitetni Klinicni Center Maribor
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-
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-
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre
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Pontevedra, Spanien, 36001
- Complexo Hospitalario Universitario de Pontevedra
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Basque Country
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Bilbao, Basque Country, Spanien, 48013
- Hospital Universitario Basurto
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Catalonia
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Barcelona, Catalonia, Spanien, 08036
- Hospital Clinic i Provincial de Barcelona
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Valencia
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Valencia, Valencia, Spanien, 46014
- Hospital General Universitario de Valencia
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-
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-
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Ankara, Tyrkiet (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
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Istanbul, Tyrkiet (Türkiye), 34390
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
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Istanbul, Tyrkiet (Türkiye), 34662
- Acibadem Altunizade Hastanesi
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Istanbul, Tyrkiet (Türkiye), 34899
- Marmara Universitesi Tip Fakultesi Hastanesi
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Samsun, Tyrkiet (Türkiye), 55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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Frankfurt am Main, Tyskland, 60590
- Universitaetsklinikum Frankfurt
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Göttingen, Tyskland, 37075
- Universitaetsmedizin Goettingen - Georg-August-Universitaet
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Hamburg, Tyskland, 22391
- MensingDerma Research GmbH
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Hamburg, Tyskland, 20537
- TFS Trial Form Support GmbH
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Hanover, Tyskland, 30625
- Medizinische Hochschule Hannover
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Hanover, Tyskland, 30159
- Hautaerzte Zentrum Hannover
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Mainz, Tyskland, 55101
- Universitaetsmedizin Mainz
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Memmingen, Tyskland, 87700
- Beldio Research Gmbh
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Merzing, Tyskland, 66663
- Hautmedizin Saar
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München, Tyskland, 80802
- Klinikum rechts der Isar der TUM
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Budapest, Ungarn, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, Ungarn, 1027
- Csalogany Orvosi Kozpont
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Budapest, Ungarn, 1033
- Clinexpert Kft
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Békéscsaba, Ungarn, 5600
- Trial Pharma Kft
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Debrecen, Ungarn, 4032
- Debreceni Egyetem Klinikai Kozpont
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Gyöngyös, Ungarn, 3200
- Gyongyosi Bugat Pal Korhaz
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Kaposvár, Ungarn, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
Orosháza, Ungarn, 5900
- DermaMed Research Kft
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Szolnok, Ungarn, 5000
- Allergo-Derm Bakos Kft
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Zalaegerszeg, Ungarn, 8900
- Obudai Egeszsegugyi Centrum Kft
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Graz, Østrig, 8036
- Medizinische Universitaet Graz
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Innsbruck, Østrig, 6020
- Medizinische Universitaet Innsbruck
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Salzburg, Østrig, 5020
- Landeskrankenhaus Salzburg
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Vienna, Østrig, 1030
- Klinik Landstrasse
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Vienna, Østrig, 1130
- Klinik Hietzing
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Alder ≥ 18 år med diagnose AD i henhold til AAD (American Academy of Dermatology) Consensus Criteria (2014) til stede i mindst 6 måneder
- Anamnese med utilstrækkelig respons på TCS af medium eller højere styrke inden for 6 måneder (med eller uden TCI)
- EASI-score ≥16
- vIGA-AD-score ≥3
- ≥10 % kropsoverfladeareal (BSA) af AD-involvering
- Værste pruritus numerisk vurderingsskala ≥ 4
Ekskluderingskriterier:
- Behandling med et biologisk produkt inden for 12 uger eller 5 halveringstider, alt efter hvad der er længst, før dag 1
Behandling med nogen af følgende medikamenter eller terapier inden for 4 uger eller 5 halveringstider, alt efter hvad der er længst, før dag 1:
- Systemiske kortikosteroider
- Systemiske immunsuppressiva
- Fototerapi
- Janus kinase hæmmere
Behandling med nogen af følgende medikamenter eller terapier inden for 1 uge før dag 1:
- TCS
- TCI
- Anti-kløemidler
- Topiske phosphodiesterase type 4-hæmmere
- Andre topiske immunsuppressive midler
- Topiske kombinationsmidler, herunder TCS af enhver styrke eller TCI, PDE4-hæmmere eller andre topiske immunsuppressive midler
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Dobbelt
Antal våben
3
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Eksperimentel: Rocatinlimab Dosis 1 + TCS/TCI
Rocatinlimab dosis 1 hver 4. uge (Q4W) i 24 uger + TCS/TCI + startdosis i uge 2.
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Subkutan (SC) injektion
Andre navne:
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Eksperimentel: Rocatinlimab Dosis 2 + TCS/TCI
Rocatinlimab dosis 2 Q4W i 24 uger + TCS/TCI + startdosis i uge 2.
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Subkutan (SC) injektion
Andre navne:
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Placebo komparator: Placebo + TCS/TCI
Placebo Q4W i 24 uger + TCS/TCI + startdosis i uge 2.
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SC injektion
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Who Achieved EASI 75 at Week 16
Tidsramme: 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
|
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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
Tidsramme: Baseline and Week 16
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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
Tidsramme: 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
Tidsramme: 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
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Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and Week 24
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The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adult patients suffering from skin disease.
The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Change From Baseline in DLQI Score at Week 24
Tidsramme: 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
Tidsramme: 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.
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Baseline and Week 24
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Change From Baseline in POEM Score at Week 24
Tidsramme: 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
|
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Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Tidsramme: 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
|
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Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Tidsramme: 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
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Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
Tidsramme: 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
Tidsramme: 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.
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Baseline and Week 24
|
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Change From Baseline in HADS-anxiety Subscale Score at Week 24
Tidsramme: 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
|
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Change From Baseline in HADS-depression Subscale Score at Week 24
Tidsramme: 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
Tidsramme: 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
|
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Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Tidsramme: 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
Tidsramme: 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.
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Baseline and Week 16
|
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Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Tidsramme: Baseline and Week 24
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Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours.
Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance.
Participants were asked to rate the intensity of their sleep disturbance using this scale each day.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in level of sleep disturbance.
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Baseline and Week 24
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Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
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
Tidsramme: Baseline and Week 16
|
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 16
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: MD, Amgen
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
21. februar 2023
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
15. september 2024
Studieafslutning (Faktiske)
Studieafslutning
4. december 2024
Datoer for studieregistrering
Først indsendt
Først indsendt
2. februar 2023
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
2. februar 2023
Først opslået (Faktiske)
Først opslået
13. februar 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
6. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. august 2026
Sidst verificeret
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 20210144
- 2022-501585-22-00 (Registry Identifier: CTIS (EU))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Afidentificerede individuelle patientdata for variabler, der er nødvendige for at løse det specifikke forskningsspørgsmål i en godkendt anmodning om datadeling.
IPD-delingstidsramme
Anmodninger om datadeling i forbindelse med denne undersøgelse vil blive overvejet begyndende 18 måneder efter, at undersøgelsen er afsluttet, og enten 1) produktet og indikationen er blevet udstedt markedsføringstilladelse i både USA og Europa eller 2) den kliniske udvikling af produktet og/eller indikationen ophører og dataene vil ikke blive indsendt til de regulerende myndigheder.
Der er ingen slutdato for berettigelse til at indsende en anmodning om datadeling for denne undersøgelse.
IPD-delingsadgangskriterier
Kvalificerede forskere kan indsende en anmodning, der indeholder forskningsmålene, Amgen-produktet/-erne og Amgen-undersøgelsen/-undersøgelserne i omfang, endepunkter/resultater af interesse, statistisk analyseplan, datakrav, publikationsplan og forskerens/forskernes kvalifikationer.
Generelt imødekommer Amgen ikke eksterne anmodninger om individuelle patientdata med det formål at revurdere sikkerheds- og effektivitetsspørgsmål, der allerede er behandlet i produktmærkningen.
Anmodninger gennemgås af et udvalg af interne rådgivere.
Hvis den ikke godkendes, vil et uafhængigt datadelingspanel mægle og træffe den endelige beslutning.
Efter godkendelse vil oplysninger, der er nødvendige for at løse forskningsspørgsmålet, blive leveret i henhold til vilkårene i en datadelingsaftale.
Dette kan omfatte anonymiserede individuelle patientdata og/eller tilgængelige understøttende dokumenter, der indeholder fragmenter af analysekode, hvor det er angivet i analysespecifikationerne.
Yderligere detaljer er tilgængelige på URL'en nedenfor.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .