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En undersøgelse af JNJ-77242113 til behandling af deltagere med moderat til svær plakpsoriasis (ICONIC-ADVANCE 2)

2. juli 2026 opdateret af: Janssen Research & Development, LLC

En fase 3 multicenter, randomiseret, dobbeltblind, placebokontrolleret og Deucravacitinib Active Comparator-kontrolleret undersøgelse til evaluering af effektiviteten og sikkerheden af ​​JNJ-77242113 til behandling af deltagere med moderat til svær plakpsoriasis

Formålet med undersøgelsen er at evaluere, hvor effektiv JNJ-77242113 er hos deltagere med moderat til svær plakpsoriasis sammenlignet med placebo og deucravacitinib.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

731

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Diagnose af plaque psoriasis, med eller uden psoriasisarthritis (PsA), i mindst 26 uger før den første administration af undersøgelsesintervention
  • Total kropsoverfladeareal (BSA) større end eller lig med (>=)10 procent (%) ved screening og baseline
  • Total psoriasisareal og sværhedsgradsindeks (PASI) >=12 ved screening og baseline
  • Total investigator global assessment (IGA) >=3 ved screening og baseline
  • Kandidat til fototerapi eller systemisk behandling af plaque psoriasis

Ekskluderingskriterier:

  • Plakfri form af psoriasis (for eksempel erytrodermisk, guttat eller pustuløs)
  • Nuværende lægemiddelinduceret psoriasis (f.eks. en ny opstået psoriasis eller en forværring af psoriasis fra betablokkere, calciumkanalblokkere eller lithium)
  • En aktuel diagnose eller tegn eller symptomer på alvorlige, progressive eller ukontrollerede nyre-, lever-, hjerte-, vaskulære, pulmonale, gastrointestinale, endokrine, neurologiske, hæmatologiske, reumatologiske, psykiatriske eller metaboliske forstyrrelser
  • Kendte allergier, overfølsomhed eller intolerance over for JNJ-77242113 eller dets hjælpestoffer
  • Større kirurgisk indgreb (for eksempel kræver generel anæstesi) inden for 8 uger før screening, eller vil ikke være helt restitueret efter kirurgisk indgreb, eller har et kirurgisk indgreb planlagt i den tid, deltageren forventes at deltage i undersøgelsen

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: JNJ-77242113
Deltagerne vil modtage JNJ-77242113 fra uge 0 til og med uge 156 og deucravacitinib-matchende placebo fra uge 0 til og med uge 24.
Medicin: JNJ-77242113
JNJ-77242113 vil blive indgivet oralt.
Medicin: Deucravacitinib Matching Placebo
Deucravacitinib matchende placebo vil blive indgivet oralt.
Placebo komparator: Placebo
Deltagerne vil modtage matchende placebo for JNJ-77242113 fra uge 0 til uge 16, matchende placebo for deucravacitinib fra uge 0 til uge 24 og JNJ-77242113 fra uge 16 til uge 156.
Medicin: JNJ-77242113
JNJ-77242113 vil blive indgivet oralt.
Medicin: JNJ-77242113 Matchende placebo
JNJ-77242113 matchende placebo vil blive indgivet oralt.
Medicin: Deucravacitinib Matching Placebo
Deucravacitinib matchende placebo vil blive indgivet oralt.
Aktiv komparator: Deucravacitinib
Deltagerne vil modtage deucravacitinib fra uge 0 til uge 24 og matchende placebo for JNJ-77242113 fra uge 0 til uge 24 og JNJ-77242113 fra uge 24 til uge 156.
Medicin: JNJ-77242113
JNJ-77242113 vil blive indgivet oralt.
Medicin: JNJ-77242113 Matchende placebo
JNJ-77242113 matchende placebo vil blive indgivet oralt.
Medicin: Deucravacitinib
Deucravacitinib vil blive indgivet oralt.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline i PASI total score i uge 16
Tidsramme: Baseline (uge 0), uge 16
Ændringen fra baseline i den samlede PASI-score i uge 16 blev rapporteret. PASI var et system, der blev brugt til at vurdere og graduere sværhedsgraden af psoriatiske læsioner og deres respons på behandling. I PASI-systemet blev kroppen opdelt i 4 regioner: hovedet, overkroppen, overekstremiteterne og underekstremiteterne. Hver af disse områder blev vurderet og scoreret separat for erytem, induration og skældannelse, som hver blev vurderet på en skala fra 0 til 4 (0=ingen, 1=svag, 2=moderat, 3=svær og 4=meget svær) og omfanget af involvering fra 0 (angav ingen involvering) til 6 (90% - 100% involvering). PASI producerede en numerisk totalscore, der kunne variere fra 0 (ingen psoriasis) til 72 (maksimal psoriasis). Højere score indikerede større sværhedsgrad af psoriasis. Baseline blev defineret som den tætteste måling taget før eller på tidspunktet for den første administrationsdato af undersøgelsesmedicinen.
Baseline (uge 0), uge 16
Percentage of Participants Who Achieved PASI 100 Response at Week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From Week 24 up to Week 160
From Week 24 up to Week 160
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Tidsramme: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Tidsramme: From Week 0 to Week 160
From Week 0 to Week 160

Samarbejdspartnere og efterforskere

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Sponsor

Janssen Research & Development, LLC

Efterforskere

  • Studieleder: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. marts 2024

Primær færdiggørelse (Faktiske)

15. november 2024

Studieafslutning (Anslået)

20. september 2027

Datoer for studieregistrering

Først indsendt

15. januar 2024

Først indsendt, der opfyldte QC-kriterier

15. januar 2024

Først opslået (Faktiske)

24. januar 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 77242113PSO3004 (Anden identifikator: Janssen Research & Development, LLC)
  • 2023-507039-39-00 (Registry Identifier: EUCT number)

Plan for individuelle deltagerdata (IPD)

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JA

IPD-planbeskrivelse

Datadelingspolitikken for Janssen Pharmaceutical Companies of Johnson & Johnson er tilgængelig på www.janssen.com/clinical-trials/transparency. Som bemærket på dette websted, kan anmodninger om adgang til undersøgelsesdata indsendes gennem Yale Open Data Access (YODA) projektwebsted på yoda.yale.edu

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Plaque Psoriasis

Kliniske forsøg med JNJ-77242113

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