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Uno studio su JNJ-77242113 per il trattamento di partecipanti con psoriasi a placche da moderata a grave (ICONIC-ADVANCE 2)

2 luglio 2026 aggiornato da: Janssen Research & Development, LLC

Uno studio di fase 3 multicentrico, randomizzato, in doppio cieco, controllato con placebo e controllato con comparatore attivo con deucravacitinib per valutare l'efficacia e la sicurezza di JNJ-77242113 per il trattamento dei partecipanti con psoriasi a placche da moderata a grave

Lo scopo dello studio è valutare l'efficacia di JNJ-77242113 nei partecipanti con psoriasi a placche da moderata a grave rispetto al placebo e a deucravacitinib.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

731

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
      • Benowa, Australia, 4217
        • The Skin Centre
      • Clayton, Australia, 3168
        • Monash Medical Centre
      • Kogarah, Australia, 2217
        • Premier Specialists
      • Melbourne, Australia, 3004
        • The Alfred Hospital
      • Mitcham, Australia, 3132
        • ISHI dermatology
      • Parkville, Australia, 3050
        • Royal Melbourne Hospital
  • Brasile
      • Botucatu, Brasile, 18618-686
        • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
      • Brasília, Brasile, 72.145-450
        • Chronos Clinica Medica LTDA Chronos Pesquisa Clinica
      • Ribeirão Preto, Brasile, 14048 900
        • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
      • Santo André, Brasile, 09060 870
        • Fundacao do ABC Centro Universitario FMABC
      • São José do Rio Preto, Brasile, 15090 000
        • Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
      • São Paulo, Brasile, 05403 900
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih ho Hong Medical
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research Inc.
    • Ontario
      • London, Ontario, Canada, N6A 5R9
        • Lovegrove Dermatology
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc.
      • Mississauga, Ontario, Canada, L4Y 4C5
        • DermEdge Research
      • Peterborough, Ontario, Canada, K9J 5K2
        • Skin Centre for Dermatology
      • Toronto, Ontario, Canada, M3H 5Y8
        • Toronto Research Centre
      • Toronto, Ontario, Canada, M2N 3A6
        • North York Research Inc
      • Windsor, Ontario, Canada, N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research Inc.
      • Québec, Quebec, Canada, G1V 4X7
        • Centre De Recherche Dermatologique Du Quebec Metropolitain
  • Corea del Sud
      • Ansan-si, Corea del Sud, 15355
        • Korea University Ansan Hospital
      • Anyang-si, Corea del Sud, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon-si, Corea del Sud, 14647
        • The Catholic University of Korea Bucheon St Mary s Hospital
      • Gwangju, Corea del Sud, 61453
        • Chosun university hospital
      • Seongnam, Corea del Sud, 13496
        • CHA Bundang Medical Center, CHA University
      • Seoul, Corea del Sud, 05505
        • Asan Medical Center
      • Seoul, Corea del Sud, 8308
        • Korea University Guro Hospital
  • Germania
      • Augsburg, Germania, 86150
        • Hautarztpraxis Dr. Mihaescu
      • Bad Bentheim, Germania, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Germania, 13627
        • CRS Clinical Research Services Berlin GmbH
      • Bochum, Germania, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, Germania, 64283
        • Klinikum Darmstadt GmbH - Hautklinik
      • Dresden, Germania, 01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Dülmen, Germania, 48249
        • Hautzentrum Dulmen
      • Düsseldorf, Germania, 40212
        • Privatpraxis Dr. Hilton & Partner
      • Friedrichshafen, Germania, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Hamburg, Germania, 20095
        • Eurofins bioskin GmbH
      • Heidelberg, Germania, 69120
        • Universitaetsklinikum Heidelberg
      • Mahlow, Germania, 15831
        • Hautarztpraxis
      • Mainz, Germania, 55131
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
      • Merzig, Germania, 66663
        • Hautmedizin Saar Science Hms GmbH
      • Münster, Germania, 48149
        • Universitaetsklinikum Muenster
      • Oldenburg, Germania, 26133
        • Klinikum Oldenburg
      • Witten, Germania, 58453
        • Hautarztpraxis 1
      • Wuppertal, Germania, 42287
        • CentroDerm GmbH
  • Polonia
      • Bialystok, Polonia, 15 797
        • Renew Clinic
      • Katowice, Polonia, 40 568
        • Care Clinic
      • Katowice, Polonia, 40 611
        • Centrum Medyczne Angelius Provita
      • Kielce, Polonia, 25-316
        • Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
      • Krakow, Polonia, 30-002
        • SGD s.c.
      • Krakow, Polonia, 30-303
        • Krakowskie Centrum Badan Klinicznych
      • Krakow, Polonia, 30-348
        • Jagiellonskie Centrum Innowacji
      • Krakow, Polonia, 31 559
        • Diamond Clinic
      • Olsztyn, Polonia, 10-117
        • Etyka Osrodek Badan Klinicznych
      • Warsaw, Polonia, 02-962
        • Royalderm Agnieszka Nawrocka
      • Warsaw, Polonia, 02 661
        • Carpe Diem Centrum Medycyny Estetycznej
      • Warsaw, Polonia, 02 672
        • Synexus Polska Sp z o o Oddzial w Warszawie
      • Wroclaw, Polonia, 51 685
        • WroMedica I Bielicka A Strzalkowska s c
  • Romania
      • Cluj-Napoca, Romania, 400105
        • Cabinet Medical Dermato-Venerologie
      • Craiova, Romania, 200541
        • Centrul Medical Vitaplus
      • Craiova, Romania, 200642
        • Spitalul Clinic Judetean de Urgenta
      • Iași, Romania, 700381
        • Sc Iasiprest Srl
      • Oradea, Romania, 410167
        • Spitalul Clinic Judetean De Urgenta Bihor
      • Timișoara, Romania, 300757
        • New Derm Clinic
      • Târgu Mureş, Romania, 540342
        • Spitalul Clinic Judetean Mures
  • Spagna
      • Alcorcón, Spagna, 28922
        • Hosp. Univ. Fundacion Alcorcon
      • Badalona, Spagna, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spagna, 08036
        • Hosp Clinic de Barcelona
      • Manises, Spagna, 46940
        • Hosp. de Manises
      • Salamanca, Spagna, 37007
        • Hosp Clinico Univ de Salamanca
      • Santiago de Compostela, Spagna, 15702
        • Clinica Gaias
      • Santiago de Compostela, Spagna, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Spagna, 41009
        • Hosp. Virgen Macarena
      • Seville, Spagna, 41014
        • Hosp. Ntra. Sra. de Valme
      • Villajoyosa, Spagna, 03570
        • Hosp. de La Marina Baixa
      • Zaragoza, Spagna, 50009
        • Hosp. Clinico Univ. Lozano Blesa
  • Stati Uniti
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85032
        • Alliance Dermatology and MOHS Center P C
    • California
      • Encinitas, California, Stati Uniti, 92024
        • California Dermatology & Clinical Research Institute
      • Encino, California, Stati Uniti, 91436
        • T Joseph Raoof Md Inc
      • Fresno, California, Stati Uniti, 93701
        • UCSF Fresno
      • Los Angeles, California, Stati Uniti, 90056
        • Wallace Medical Group, Inc
      • Los Angeles, California, Stati Uniti, 90024
        • University of California Los Angeles - Division of Dermatology
      • Oceanside, California, Stati Uniti, 92056
        • Dermatologist Medical Group of North County, Inc.
    • Florida
      • Miami, Florida, Stati Uniti, 33155
        • Bioclinical Research Alliance Inc.
      • Miami, Florida, Stati Uniti, 33133
        • Miami Dermatology And Laser Institute
      • Tampa, Florida, Stati Uniti, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Douglasville, Georgia, Stati Uniti, 30135
        • Southeast Dermatology Specialists
    • Illinois
      • Rolling Meadows, Illinois, Stati Uniti, 60008
        • Arlington Dermatology
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40217
        • Skin Sciences, PLLC
      • Owensboro, Kentucky, Stati Uniti, 42301
        • Qualmedica Research
    • Maryland
      • Rockville, Maryland, Stati Uniti, 20850
        • DermAssociates, PC
    • Massachusetts
      • Brighton, Massachusetts, Stati Uniti, 02135
        • Metro Boston Clinical Partners
      • Methuen, Massachusetts, Stati Uniti, 01844
        • ActivMed Practices and Research
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • University of Michigan
      • Bay City, Michigan, Stati Uniti, 48706
        • Great Lakes Research Group
      • Caledonia, Michigan, Stati Uniti, 49316
        • The Derm Institute of West Michigan
      • Canton, Michigan, Stati Uniti, 48187
        • Hamzavi Dermatology
      • Troy, Michigan, Stati Uniti, 48084
        • Somerset Skin Centre
    • Missouri
      • Kirksville, Missouri, Stati Uniti, 63501
        • Cleaver Dermatology
    • Ohio
      • Bexley, Ohio, Stati Uniti, 43209
        • Bexley dermatology research
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti, 74137
        • Essential Medical Research
    • Oregon
      • Portland, Oregon, Stati Uniti, 97210-2996
        • Oregon Dermatology & Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19103
        • Paddington Testing Co, Inc.
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29407
        • Clinical Research Center of the Carolinas LLC
      • Greenville, South Carolina, Stati Uniti, 29615
        • Palmetto Clinical Trial Services, LLC
    • Texas
      • Arlington, Texas, Stati Uniti, 76011
        • Arlington Research Center, Inc.
      • Dallas, Texas, Stati Uniti, 75390
        • UT Southwestern Medical Center
      • San Antonio, Texas, Stati Uniti, 78229
        • Dermatology Clinical Research Center of San Antonio
      • Webster, Texas, Stati Uniti, 77598
        • Center for Clinical Studies
    • Utah
      • Bountiful, Utah, Stati Uniti, 84010
        • Cope Family Medicine - Ogden Clinic
      • Springville, Utah, Stati Uniti, 84663
        • Springville Dermatology CCT Research
      • West Valley City, Utah, Stati Uniti, 84120
        • Kalo Clinical Research
    • Virginia
      • Norfolk, Virginia, Stati Uniti, 23502
        • Virginia Dermatology Skin Cancer Center Pllc
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan, 710
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 110
        • Taipei Medical University
      • Taipei, Taiwan, 116
        • Taipei Municipal Wanfang Hospital
  • Ungheria
      • Budapest, Ungheria, 1152
        • Uno Medical Trials Ltd.
      • Gyula, Ungheria, 5700
        • Synexus Magyarorszag Kft
      • Gyöngyös, Ungheria, 3200
        • Bugát Pál Kórház
      • Kecskemét, Ungheria, 6000
        • Bacs Kiskun Varmegyei Oktatokorhaz
      • Zalaegerszeg, Ungheria, H-8900
        • Synexus Magyarorszag Kft 1

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Diagnosi di psoriasi a placche, con o senza artrite psoriasica (PsA), per almeno 26 settimane prima della prima somministrazione dell'intervento in studio
  • Superficie corporea totale (BSA) maggiore o uguale a (>=) 10% (%) allo screening e al basale
  • Area totale della psoriasi e indice di gravità (PASI) >=12 allo screening e al basale
  • Valutazione globale totale dello sperimentatore (IGA) >=3 allo screening e al basale
  • Candidato alla fototerapia o al trattamento sistemico per la psoriasi a placche

Criteri di esclusione:

  • Forma di psoriasi non a placche (ad esempio eritrodermica, guttata o pustolosa)
  • Psoriasi attuale indotta da farmaci (ad esempio, una nuova insorgenza di psoriasi o una esacerbazione della psoriasi da beta-bloccanti, bloccanti dei canali del calcio o litio)
  • Una diagnosi attuale o segni o sintomi di disturbi renali, epatici, cardiaci, vascolari, polmonari, gastrointestinali, endocrini, neurologici, ematologici, reumatologici, psichiatrici o metabolici gravi, progressivi o non controllati
  • Allergie note, ipersensibilità o intolleranza a JNJ-77242113 o ai suoi eccipienti
  • Intervento chirurgico maggiore (ad esempio, che richiede anestesia generale) entro 8 settimane prima dello screening, o non si sarà completamente ripreso dall'intervento chirurgico, o ha una procedura chirurgica pianificata durante il periodo in cui è prevista la partecipazione del partecipante allo studio

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: JNJ-77242113
I partecipanti riceveranno JNJ-77242113 dalla settimana 0 alla settimana 156 e deucravacitinib corrispondente al placebo dalla settimana 0 alla settimana 24.
Droga: JNJ-77242113
JNJ-77242113 verrà somministrato per via orale.
Droga: Placebo corrispondente a Deucravacitinib
Deucravacitinib corrispondente al placebo sarà somministrato per via orale.
Comparatore placebo: Placebo
I partecipanti riceveranno il placebo corrispondente per JNJ-77242113 dalla settimana 0 alla settimana 16, il placebo corrispondente per deucravacitinib dalla settimana 0 alla settimana 24 e JNJ-77242113 dalla settimana 16 alla settimana 156.
Droga: JNJ-77242113
JNJ-77242113 verrà somministrato per via orale.
Droga: JNJ-77242113 Placebo corrispondente
Il placebo corrispondente al JNJ-77242113 verrà somministrato per via orale.
Droga: Placebo corrispondente a Deucravacitinib
Deucravacitinib corrispondente al placebo sarà somministrato per via orale.
Comparatore attivo: Deucravacitinib
I partecipanti riceveranno deucravacitinib dalla settimana 0 alla settimana 24 e placebo corrispondente per JNJ-77242113 dalla settimana 0 alla settimana 24 e JNJ-77242113 dalla settimana 24 alla settimana 156.
Droga: JNJ-77242113
JNJ-77242113 verrà somministrato per via orale.
Droga: JNJ-77242113 Placebo corrispondente
Il placebo corrispondente al JNJ-77242113 verrà somministrato per via orale.
Droga: Deucravacitinib
Deucravacitinib verrà somministrato per via orale.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: Week 16
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.
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Lasso di tempo: Week 16
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.
Week 16

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Variazione dal Basale del Punteggio Totale PASI alla Settimana 16
Lasso di tempo: Baseline (Settimana 0), Settimana 16
La variazione rispetto al basale del punteggio totale PASI alla Settimana 16 è stata riportata. Il PASI era un sistema utilizzato per valutare e classificare la gravità delle lesioni psoriasiche e la loro risposta alla terapia. Nel sistema PASI, il corpo era suddiviso in 4 regioni: testa, tronco, arti superiori e arti inferiori. Ciascuna di queste aree era valutata e punteggiata separatamente per eritema, indurimento e desquamazione, ciascuna classificata su una scala da 0 a 4 (0=nessuno, 1=lieve, 2=moderato, 3=grave e 4=moltograve) e per estensione del coinvolgimento da 0 (indicava nessun coinvolgimento) a 6 (90% - 100% di coinvolgimento). Il PASI produceva un punteggio totale numerico che poteva variare da 0 (nessuna psoriasi) a 72 (psoriasi massima). Un punteggio più alto indicava una maggiore gravità della psoriasi. Il basale era definito come la misurazione più vicina effettuata prima o al momento della data di somministrazione del primo farmaco dello studio.
Baseline (Settimana 0), Settimana 16
Percentage of Participants Who Achieved PASI 100 Response at Week 16
Lasso di tempo: Week 16
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.
Week 16
Change From Baseline in Body Surface Area (BSA) at Week 16
Lasso di tempo: Baseline (Week 0), Week 16
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.
Baseline (Week 0), Week 16
Percent Change From Baseline in PASI Total Score at Week 16
Lasso di tempo: Baseline (Week 0), Week 16
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.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Lasso di tempo: Week 16
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.
Week 16
Percentage of Participants Who Achieved PASI 75 Response at Weeks 4 and 16
Lasso di tempo: 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.
Weeks 4 and 16
Percentage of Participants Who Achieved PASI 90 Response at Week 8
Lasso di tempo: 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.
Week 8
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
Lasso di tempo: Week 16
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.
Week 16
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
Lasso di tempo: Weeks 8 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 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From Week 24 up to Week 160
From Week 24 up to Week 160
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Lasso di tempo: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Lasso di tempo: From Week 0 to Week 160
From Week 0 to Week 160

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Investigatori

  • Direttore dello studio: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 marzo 2024

Completamento primario (Effettivo)

15 novembre 2024

Completamento dello studio (Stimato)

20 settembre 2027

Date di iscrizione allo studio

Primo inviato

15 gennaio 2024

Primo inviato che soddisfa i criteri di controllo qualità

15 gennaio 2024

Primo Inserito (Effettivo)

24 gennaio 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 77242113PSO3004 (Altro identificatore: Janssen Research & Development, LLC)
  • 2023-507039-39-00 (Identificatore di registro: EUCT number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

La politica di condivisione dei dati delle società farmaceutiche Janssen di Johnson & Johnson è disponibile all'indirizzo www.janssen.com/clinical-trials/transparency. Come indicato su questo sito, le richieste di accesso ai dati dello studio possono essere inviate tramite il sito del progetto Yale Open Data Access (YODA) all'indirizzo yoda.yale.edu

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Jamaica

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

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