Un estudio de JNJ-77242113 para el tratamiento de participantes con psoriasis en placas de moderada a grave (ICONIC-ADVANCE 2)
27 de agosto de 2026 actualizado por: Janssen Research & Development, LLC
Un estudio de fase 3 multicéntrico, aleatorizado, doble ciego, controlado con placebo y controlado con comparador activo de deucravacitinib para evaluar la eficacia y seguridad de JNJ-77242113 para el tratamiento de participantes con psoriasis en placas de moderada a grave
El propósito del estudio es evaluar qué tan efectivo es JNJ-77242113 en participantes con psoriasis en placas de moderada a grave en comparación con placebo y deucravacitinib.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
731
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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Augsburg, Alemania, 86150
- Hautarztpraxis Dr. Mihaescu
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Bad Bentheim, Alemania, 48455
- Fachklinik Bad Bentheim
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Berlin, Alemania, 13627
- CRS Clinical Research Services Berlin GMBH
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Bochum, Alemania, 44793
- Niesmann & Othlinghaus GbR
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Darmstadt, Alemania, 64283
- Klinikum Darmstadt GmbH - Hautklinik
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Dresden, Alemania, 01307
- Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
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Dülmen, Alemania, 48249
- Hautzentrum Dulmen
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Düsseldorf, Alemania, 40212
- Privatpraxis Dr. Hilton & Partner
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Friedrichshafen, Alemania, 88045
- Derma-Study-Center Friedrichshafen GmbH
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Hamburg, Alemania, 20095
- Eurofins bioskin GmbH
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Heidelberg, Alemania, 69120
- Universitaetsklinikum Heidelberg
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Mahlow, Alemania, 15831
- Hautarztpraxis
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Mainz, Alemania, 55131
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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Merzig, Alemania, 66663
- Hautmedizin Saar Science Hms GmbH
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Münster, Alemania, 48149
- Universitaetsklinikum Muenster
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Oldenburg, Alemania, 26133
- Klinikum Oldenburg
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Witten, Alemania, 58453
- Hautarztpraxis 1
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Wuppertal, Alemania, 42287
- CentroDerm GmbH
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Benowa, Australia, 4217
- The Skin Centre
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Clayton, Australia, 3168
- Monash Medical Centre
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Kogarah, Australia, 2217
- Premier Specialists
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Melbourne, Australia, 3004
- The Alfred Hospital
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Mitcham, Australia, 3132
- ISHI dermatology
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Parkville, Australia, 3050
- Royal Melbourne Hospital
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Botucatu, Brasil, 18618-686
- UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
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Brasília, Brasil, 72145-450
- Chronos Clinica Medica Ltda
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Ribeirão Preto, Brasil, 14051140
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
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São José do Rio Preto, Brasil, 15090-000
- Funfarme Sjrp
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São Paulo, Brasil, 05403 900
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
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São Paulo, Brasil, 09060-870
- Cepes - Fmabc
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British Columbia
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Surrey, British Columbia, Canadá, V3R 6A7
- Dr. Chih ho Hong Medical
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Manitoba
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Winnipeg, Manitoba, Canadá, R3M 3Z4
- Wiseman Dermatology Research Inc.
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Ontario
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London, Ontario, Canadá, N6A 5R9
- Lovegrove Dermatology
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Markham, Ontario, Canadá, L3P 1X2
- Lynderm Research Inc.
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Mississauga, Ontario, Canadá, L4Y 4C5
- DermEdge Research
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Peterborough, Ontario, Canadá, K9J 5K2
- SKiN Centre for Dermatology
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Toronto, Ontario, Canadá, M3H 5Y8
- Toronto Research Centre
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Toronto, Ontario, Canadá, M2N 3A6
- North York Research Inc
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Windsor, Ontario, Canadá, N8T 1E6
- XLR8 Medical Research
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Quebec
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Montreal, Quebec, Canadá, H2X 2V1
- Innovaderm Research Inc.
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Québec, Quebec, Canadá, G1V 4X7
- Centre de Recherche Dermatologique du Quebec metropolitain
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Ansan-si, Corea del Sur, 15355
- Korea University Ansan Hospital
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Anyang-si, Corea del Sur, 14068
- Hallym University Sacred Heart Hospital
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Bucheon-si, Corea del Sur, 14647
- The Catholic University of Korea Bucheon St Mary s Hospital
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Gwangju, Corea del Sur, 61453
- Chosun University Hospital
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Seongnam, Corea del Sur, 13496
- CHA Bundang Medical Center, CHA University
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Seoul, Corea del Sur, 05505
- Asan Medical Center
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Seoul, Corea del Sur, 8308
- Korea University Guro Hospital
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Alcorcón, España, 28922
- Hosp. Univ. Fundacion Alcorcon
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Badalona, España, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, España, 08036
- Hosp Clinic de Barcelona
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Manises, España, 46940
- Hosp. de Manises
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Salamanca, España, 37007
- Hosp Clinico Univ de Salamanca
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Santiago de Compostela, España, 15702
- Clinica Gaias
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Santiago de Compostela, España, 15706
- Hosp. Clinico Univ. de Santiago
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Seville, España, 41009
- Hosp. Virgen Macarena
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Seville, España, 41014
- Hosp. Ntra. Sra. de Valme
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Villajoyosa, España, 03570
- Hosp. de La Marina Baixa
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Zaragoza, España, 50009
- Hosp. Clinico Univ. Lozano Blesa
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Arizona
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Phoenix, Arizona, Estados Unidos, 85032
- Alliance Dermatology and MOHS Center P C
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California
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Encinitas, California, Estados Unidos, 92024
- California Dermatology & Clinical Research Institute
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Encino, California, Estados Unidos, 91436
- T Joseph Raoof Md Inc
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Fresno, California, Estados Unidos, 93701
- Ucsf Fresno
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Los Angeles, California, Estados Unidos, 90056
- Wallace Medical Group, Inc
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Los Angeles, California, Estados Unidos, 90024
- University of California Los Angeles - Division of Dermatology
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Oceanside, California, Estados Unidos, 92056
- Dermatologist Medical Group of North County, Inc.
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Florida
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Miami, Florida, Estados Unidos, 33155
- Bioclinical Research Alliance Inc.
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Miami, Florida, Estados Unidos, 33133
- Miami Dermatology And Laser Institute
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Tampa, Florida, Estados Unidos, 33613
- Forcare Clinical Research Inc
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Georgia
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Douglasville, Georgia, Estados Unidos, 30135
- Southeast Dermatology Specialists
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Illinois
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Rolling Meadows, Illinois, Estados Unidos, 60008
- Arlington Dermatology
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40217
- Skin Sciences, PLLC
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Owensboro, Kentucky, Estados Unidos, 42301
- Qualmedica Research
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Maryland
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Rockville, Maryland, Estados Unidos, 20850
- DermAssociates, PC
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Massachusetts
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Brighton, Massachusetts, Estados Unidos, 02135
- Metro Boston Clinical Partners
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Methuen, Massachusetts, Estados Unidos, 01844
- ActivMed Practices and Research
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
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Bay City, Michigan, Estados Unidos, 48706
- Great Lakes Research Group
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Caledonia, Michigan, Estados Unidos, 49316
- The Derm Institute of West Michigan
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Canton, Michigan, Estados Unidos, 48187
- Hamzavi Dermatology
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Troy, Michigan, Estados Unidos, 48084
- Somerset Skin Centre
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Missouri
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Kirksville, Missouri, Estados Unidos, 63501
- Cleaver Dermatology
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Ohio
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Bexley, Ohio, Estados Unidos, 43209
- Bexley Dermatology Research
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74137
- Essential Medical Research
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Oregon
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Portland, Oregon, Estados Unidos, 97210-2996
- Oregon Dermatology & Research Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19103
- Paddington Testing Co, Inc.
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29407
- Clinical Research Center of the Carolinas LLC
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Greenville, South Carolina, Estados Unidos, 29615
- Palmetto Clinical Trial Services, LLC
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Texas
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Arlington, Texas, Estados Unidos, 76011
- Arlington Research Center, inc.
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern Medical Center
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San Antonio, Texas, Estados Unidos, 78229
- Dermatology Clinical Research Center of San Antonio
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Webster, Texas, Estados Unidos, 77598
- Center for Clinical Studies
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Utah
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Bountiful, Utah, Estados Unidos, 84010
- Cope Family Medicine - Ogden Clinic
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Springville, Utah, Estados Unidos, 84663
- Springville Dermatology CCT Research
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West Valley City, Utah, Estados Unidos, 84120
- Kalo Clinical Research
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
- Virginia Dermatology Skin Cancer Center Pllc
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Budapest, Hungría, 1152
- Uno Medical Trials Ltd.
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Gyula, Hungría, 5700
- Synexus Magyarorszag Kft
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Gyöngyös, Hungría, 3200
- Bugat Pal Korhaz
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Kecskemét, Hungría, 6000
- Bacs Kiskun Varmegyei Oktatokorhaz
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Zalaegerszeg, Hungría, H-8900
- Synexus Magyarorszag Kft 1
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Bialystok, Polonia, 15 797
- Renew Clinic
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Katowice, Polonia, 40 568
- CaRe Clinic
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Katowice, Polonia, 40 611
- Centrum Medyczne Angelius Provita
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Kielce, Polonia, 25-316
- Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
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Krakow, Polonia, 30-002
- SGD s.c.
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Krakow, Polonia, 30-303
- Krakowskie Centrum Badan Klinicznych
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Krakow, Polonia, 30-348
- Jagiellonskie Centrum Innowacji
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Krakow, Polonia, 31 559
- Diamond Clinic
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Olsztyn, Polonia, 10-117
- Etyka Osrodek Badan Klinicznych
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Warsaw, Polonia, 02-962
- Royalderm Agnieszka Nawrocka
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Warsaw, Polonia, 02 661
- Carpe Diem Centrum Medycyny Estetycznej
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Warsaw, Polonia, 02 672
- Synexus Polska Sp z o o Oddzial w Warszawie
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Wroclaw, Polonia, 51 685
- WroMedica I Bielicka A Strzalkowska s c
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Cluj-Napoca, Rumania, 400105
- Cabinet Medical Dermato-Venerologie
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Craiova, Rumania, 200541
- Centrul Medical Vitaplus
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Craiova, Rumania, 200642
- Spitalul Clinic Județean de Urgență
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Iași, Rumania, 700381
- Sc Iasiprest Srl
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Oradea, Rumania, 410167
- Spitalul Clinic Judetean De Urgenta Bihor
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Timișoara, Rumania, 300757
- New Derm Clinic
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Târgu Mureş, Rumania, 540342
- Spitalul Clinic Judetean Mures
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Kaohsiung City, Taiwán, 81362
- Kaohsiung Veterans General Hospital
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Kaohsiung City, Taiwán, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taichung, Taiwán, 40705
- Taichung Veterans General Hospital
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Taichung, Taiwán, 40201
- Chung Shan Medical University Hospital
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Tainan, Taiwán, 710
- National Cheng Kung University Hospital
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Taipei, Taiwán, 110
- Taipei Medical University
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Taipei, Taiwán, 116
- Taipei Municipal Wanfang Hospital
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Diagnóstico de psoriasis en placas, con o sin artritis psoriásica (PsA), durante al menos 26 semanas antes de la primera administración de la intervención del estudio.
- Área de superficie corporal total (BSA) mayor o igual a (>=)10 por ciento (%) en el momento de la selección y al inicio
- Área total de psoriasis e índice de gravedad (PASI) >=12 en el momento de selección y al inicio del estudio
- Evaluación global total del investigador (IGA) >=3 en la selección y al inicio
- Candidato a fototerapia o tratamiento sistémico para la psoriasis en placas.
Criterio de exclusión:
- Forma de psoriasis sin placas (por ejemplo, eritrodérmica, guttata o pustulosa)
- Psoriasis actual inducida por fármacos (por ejemplo, una nueva aparición de psoriasis o una exacerbación de la psoriasis por betabloqueantes, bloqueadores de los canales de calcio o litio)
- Un diagnóstico actual o signos o síntomas de trastornos renales, hepáticos, cardíacos, vasculares, pulmonares, gastrointestinales, endocrinos, neurológicos, hematológicos, reumatológicos, psiquiátricos o metabólicos graves, progresivos o no controlados.
- Alergias, hipersensibilidad o intolerancia conocidas a JNJ-77242113 o sus excipientes
- Procedimiento quirúrgico mayor (por ejemplo, que requiera anestesia general) dentro de las 8 semanas previas a la selección, o no se habrá recuperado completamente del procedimiento quirúrgico, o tiene un procedimiento quirúrgico planificado durante el tiempo que se espera que el participante participe en el estudio.
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 paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: JNJ-77242113
Los participantes recibirán JNJ-77242113 desde la semana 0 hasta la semana 156 y un placebo equivalente a deucravacitinib desde la semana 0 hasta la semana 24.
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JNJ-77242113 se administrará por vía oral.
Se administrará un placebo equivalente a deucravacitinib por vía oral.
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Comparador de placebos: Placebo
Los participantes recibirán un placebo equivalente para JNJ-77242113 desde la semana 0 hasta la semana 16, un placebo equivalente para deucravacitinib desde la semana 0 hasta la semana 24 y JNJ-77242113 desde la semana 16 hasta la semana 156.
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JNJ-77242113 se administrará por vía oral.
El placebo equivalente JNJ-77242113 se administrará por vía oral.
Se administrará un placebo equivalente a deucravacitinib por vía oral.
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Comparador activo: Deucravacitinib
Los participantes recibirán deucravacitinib desde la semana 0 hasta la semana 24 y un placebo equivalente para JNJ-77242113 desde la semana 0 hasta la semana 24 y JNJ-77242113 desde la semana 24 hasta la semana 156.
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JNJ-77242113 se administrará por vía oral.
El placebo equivalente JNJ-77242113 se administrará por vía oral.
Deucravacitinib se administrará por vía oral.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
Periodo de tiempo: Week 16
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IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using 5 point scale.
Induration: 0 =no evidence of plaque elevation, 1=minimal plaque elevation,= 0.25 millimeters (mm); 2=mild plaque elevation,= 0.5 mm; 3=moderate plaque elevation,= 0.75 mm; 4=severe plaque elevation, greater than (>) 1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates.
Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Higher score=more severe disease.
Baseline=closest measurement taken prior to or at the time of first study drug administration date.
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Week 16
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Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Periodo de tiempo: Week 16
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Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 16
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cambio desde el valor basal en la puntuación total del PASI en la semana 16
Periodo de tiempo: Línea de base (Semana 0), Semana 16
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Se informó el cambio desde el valor basal en la puntuación total del PASI en la semana 16.
El PASI era un sistema utilizado para evaluar y clasificar la gravedad de las lesiones psoriásicas y su respuesta a la terapia.
En el sistema PASI, el cuerpo se dividía en 4 regiones: la cabeza, el tronco, las extremidades superiores y las extremidades inferiores.
Cada una de estas áreas se evaluaba y puntuaba por separado para eritema, induración y descamación, que se clasificaban cada una en una escala de 0 a 4 (0=ausente, 1=leve, 2=moderado, 3=grave y 4=muy grave) y la extensión de la afectación de 0 (indicaba ninguna afectación) a 6 (90% - 100% de afectación).
El PASI producía una puntuación total numérica que podía oscilar entre 0 (sin psoriasis) y 72 (psoriasis máxima).
Una puntuación más alta indicaba una mayor gravedad de la psoriasis.
El valor basal se definía como la medición más cercana tomada antes o en la fecha de la primera administración del fármaco del estudio.
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Línea de base (Semana 0), Semana 16
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Percentage of Participants Who Achieved PASI 100 Response at Week 16
Periodo de tiempo: Week 16
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Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 16
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Change From Baseline in Body Surface Area (BSA) at Week 16
Periodo de tiempo: Baseline (Week 0), Week 16
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A BSA was commonly used measure of severity of skin disease.
It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis).
BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Baseline (Week 0), Week 16
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Percent Change From Baseline in PASI Total Score at Week 16
Periodo de tiempo: Baseline (Week 0), Week 16
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Percent change from baseline in PASI total score at Week 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Baseline (Week 0), Week 16
|
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Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Periodo de tiempo: Week 16
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The IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using a 5 point scale.
Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates.
Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
A higher score indicated more severe disease.
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Week 16
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Percentage of Participants Who Achieved PASI 75 Response at Weeks 4 and 16
Periodo de tiempo: Weeks 4 and 16
|
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 4 and 16 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Weeks 4 and 16
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Percentage of Participants Who Achieved PASI 90 Response at Week 8
Periodo de tiempo: Week 8
|
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 8 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 8
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Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2
Periodo de tiempo: Week 16
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The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis.
The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4.
A higher score indicated more severe disease.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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Week 16
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Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0
Periodo de tiempo: Weeks 8 and 16
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PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 8 and 16
|
|
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16 Among Participants With a Baseline PSSD Itch Score >=4
Periodo de tiempo: Weeks 4 and 16
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease.
Baseline=closest measurement taken prior to or at time of first study drug administration date.
|
Weeks 4 and 16
|
|
Percentage of Participants Who Achieved an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Weeks 16 and 24
Periodo de tiempo: Weeks 16 and 24
|
IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using 5 point scale.
Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25mm;
2=mild plaque elevation,=0.5
mm; 3=moderate plaque elevation,=0.75
mm; 4=severe plaque elevation,>1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates.
Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Higher score=more severe disease.Baseline=closest measurement taken prior to or at time of first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved an IGA Score of 0 at Weeks 16 and 24
Periodo de tiempo: Weeks 16 and 24
|
The IGA assesses participant's plaque psoriasis.
Lesions were graded for induration, erythema and scaling, each using a 5 point scale.
Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates.
Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
A higher score indicated more severe disease.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24
Periodo de tiempo: Weeks 16 and 24
|
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 16 and 24 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24
Periodo de tiempo: Weeks 16 and 24
|
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Weeks 16 and 24 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PASI 100 Response at Weeks 16 and 24
Periodo de tiempo: Weeks 16 and 24
|
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Weeks 16 and 24 was reported.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy.
In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities.
Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement).
The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis).
Higher score indicated greater severity of psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With a Baseline PSSD Symptom Score >0
Periodo de tiempo: Week 16
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline sPGA-G Score >=2
Periodo de tiempo: Week 16
|
The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point.
The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions.
The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).
Higher score indicates more severity.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and a >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
Periodo de tiempo: Week 16
|
The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet.
hf-PFA was categorized from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Higher score indicates more severity.
Meeting the hf-PGA 0 or 1 criteria defined as having an hf-PGA score of clear (0) or almost clear (1) and a >=2-grade improvement from baseline.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With a Baseline mNAPSI Score >0
Periodo de tiempo: Baseline (Week 0), Week 16
|
Percent change from baseline in mNAPSI score at week 16 was reported.
The mNAPSI was an index used for assessing and grading the severity of nail psoriasis.
Each of the participant's ten fingernails were evaluated on 7 features.
The first three features were each scored from 0 to 3 in severity and were 1=onycholysis and oil-drop dyschromia, 2=pitting, and 3=nail plate crumbling.
Next four features was each scored 0 (absent) or 1 (present), and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in lunula.
Each fingernail was rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement).
Total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement).
Higher the score the more severe the nail bed psoriasis.
Baseline=closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With a Baseline f-PGA Score >=2
Periodo de tiempo: Week 16
|
Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported.
f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1).
The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease.
A global score of between 0 indicating clear, and 4 indicating severe.
The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
Baseline = closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Change From Baseline in PSSD Symptom Score at Week 16
Periodo de tiempo: Baseline (Week 0), Week 16
|
Change from baseline in PSSD symptoms scores at Week 16 was reported.
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Change From Baseline in PSSD Sign Score at Week 16
Periodo de tiempo: Baseline (Week 0), Week 16
|
Change from baseline in PSSD sign scores at Week 16 was reported.
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0
Periodo de tiempo: Week 16
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With a Baseline GenPS-SFQ Item 2 Score >=2 and With a Baseline sPGA-G Score >=3
Periodo de tiempo: Week 16
|
The GenPs-SFQ was a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days.
Item 1 assesses overall frequency of sexual activity in the last 7 days (none/zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (0 = never, 1 = rarely, 2 = sometimes, 3 = often, or 4 = always).
Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Percentage of Participants Who Achieved Dermatological Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1
Periodo de tiempo: Week 16
|
The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL.
It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL).
The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 16
|
|
Change From Baseline in Total DLQI Score at Week 16
Periodo de tiempo: Baseline (Week 0), Week 16
|
The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL.
It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL).
The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Change From Baseline in Domain Scores of the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
Periodo de tiempo: Baseline (Week 0), Week 16
|
PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity.
Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always).
Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain).
Higher score= worst pain.
Each domain included 4 items, plus a single pain intensity item totaling 29 items.
Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score).
Higher PROMIS T-score=more of concept being measured that is higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning.
Baseline: closest measurement taken prior to or at time of first study drug administration date.
|
Baseline (Week 0), Week 16
|
|
Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1
Periodo de tiempo: Weeks 16 and 24
|
The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL.
It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL).
The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL.
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Weeks 16 and 24
|
|
Percentage of Participants Who Achieved PSSD Symptoms Score of 0 at Week 24 Among Participants With a Baseline PSSD Symptom Score >0
Periodo de tiempo: Week 24
|
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit.
24-hour recall version was used.
PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity.
Each individual item score over seven days was averaged into a weekly item score.
Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items).
Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe).
The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
|
Week 24
|
|
Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24
Periodo de tiempo: From Week 24 up to Week 160
|
From Week 24 up to Week 160
|
|
|
Percentage of Participants Achieving PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24
Periodo de tiempo: From Week 24 up to Week 160
|
From Week 24 up to Week 160
|
|
|
Percentage of Participants Achieving IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24
Periodo de tiempo: From Week 24 up to Week 160
|
From Week 24 up to Week 160
|
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Periodo de tiempo: From Week 0 to Week 160
|
From Week 0 to Week 160
|
|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Periodo de tiempo: From Week 0 to Week 160
|
From Week 0 to Week 160
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
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.
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)
9 de marzo de 2024
Finalización primaria (Actual)
15 de noviembre de 2024
Finalización del estudio (Estimado)
20 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
15 de enero de 2024
Primero enviado que cumplió con los criterios de control de calidad
15 de enero de 2024
Publicado por primera vez (Actual)
24 de enero de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 77242113PSO3004 (Otro identificador: Janssen Research & Development, LLC)
- 2023 (Subvención/contrato del NIH de EE. UU.: GRAMMY Museum Foundation)
- 2023-507039-39-00 (Identificador de registro: EUCT number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
La política de intercambio de datos de Janssen Pharmaceutical Companies de Johnson & Johnson está disponible en www.janssen.com/clinical-trials/transparency.
Como se indica en este sitio, las solicitudes de acceso a los datos del estudio se pueden enviar a través del sitio del Proyecto Yale Open Data Access (YODA) en yoda.yale.edu.
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. .