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Studie JNJ-77242113 pro léčbu účastníků se středně těžkou až těžkou plakovou psoriázou (ICONIC-ADVANCE 2)

29. května 2026 aktualizováno: Janssen Research & Development, LLC

Multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná a aktivním komparátorem kontrolovaná studie fáze 3 k vyhodnocení účinnosti a bezpečnosti JNJ-77242113 pro léčbu účastníků se středně těžkou až těžkou plakovou psoriázou

Účelem studie je vyhodnotit, jak účinný je JNJ-77242113 u účastníků se středně těžkou až těžkou ložiskovou psoriázou ve srovnání s placebem a deukravacitinibem.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

731

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Austrálie
      • Benowa, Austrálie, 4217
        • The Skin Centre
      • Clayton, Austrálie, 3168
        • Monash Medical Centre
      • Kogarah, Austrálie, 2217
        • Premier Specialists
      • Melbourne, Austrálie, 3004
        • The Alfred Hospital
      • Mitcham, Austrálie, 3132
        • ISHI dermatology
      • Parkville, Austrálie, 3050
        • Royal Melbourne Hospital
  • Brazílie
      • Botucatu, Brazílie, 18618-687
        • Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu
      • Brasília, Brazílie, 72.145-450
        • Chronos Clinica Medica LTDA Chronos Pesquisa Clinica
      • Ribeirão Preto, Brazílie, 14048 900
        • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
      • Santo André, Brazílie, 09060 870
        • Fundacao do ABC Centro Universitario FMABC
      • São José do Rio Preto, Brazílie, 15090 000
        • Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
      • São Paulo, Brazílie, 05403 900
        • Hospital das Clinicas da Faculdade de Medicina da USP
  • Jižní Korea
      • Ansan-si, Jižní Korea, 15355
        • Korea University Ansan Hospital
      • Anyang-si, Jižní Korea, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon-si, Jižní Korea, 14647
        • The Catholic University of Korea Bucheon St Mary s Hospital
      • Gwangju, Jižní Korea, 61453
        • Chosun University Hospital
      • Seongnam, Jižní Korea, 13496
        • CHA Bundang Medical Center, CHA University
      • Seoul, Jižní Korea, 05505
        • Asan Medical Center
      • Seoul, Jižní Korea, 8308
        • Korea University Guro Hospital
  • Kanada
    • British Columbia
      • Surrey, British Columbia, Kanada, V3R 6A7
        • Dr. Chih ho Hong Medical
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3M 3Z4
        • Wiseman Dermatology Research Inc.
    • Ontario
      • London, Ontario, Kanada, N6A 5R9
        • Lovegrove Dermatology
      • Markham, Ontario, Kanada, L3P 1X2
        • Lynderm Research Inc.
      • Mississauga, Ontario, Kanada, L4Y 4C5
        • DermEdge Research
      • Peterborough, Ontario, Kanada, K9J 5K2
        • SKiN Centre for Dermatology
      • Toronto, Ontario, Kanada, M3H 5Y8
        • Toronto Research Centre
      • Toronto, Ontario, Kanada, M2N 3A6
        • North York Research Inc
      • Windsor, Ontario, Kanada, N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, Kanada, H2X 2V1
        • Innovaderm Research Inc.
      • Québec, Quebec, Kanada, G1V 4X7
        • Centre de Recherche Dermatologique du Quebec Metropolitain
  • Maďarsko
      • Budapest, Maďarsko, 1152
        • Uno Medical Trials Ltd.
      • Gyula, Maďarsko, 5700
        • Synexus Magyarorszag Kft
      • Gyöngyös, Maďarsko, 3200
        • Bugát Pál Kórház
      • Kecskemét, Maďarsko, 6000
        • Bacs Kiskun Varmegyei Oktatokorhaz
      • Zalaegerszeg, Maďarsko, H-8900
        • Synexus Magyarorszag Kft 1
  • Německo
      • Augsburg, Německo, 86150
        • Hautarztpraxis Dr. Mihaescu
      • Bad Bentheim, Německo, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Německo, 13627
        • CRS Clinical Research Services Berlin GmbH
      • Bochum, Německo, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, Německo, 64283
        • Klinikum Darmstadt GmbH - Hautklinik
      • Dresden, Německo, 01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Dülmen, Německo, 48249
        • Hautzentrum Dulmen
      • Düsseldorf, Německo, 40212
        • Privatpraxis Dr. Hilton & Partner
      • Friedrichshafen, Německo, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Hamburg, Německo, 20095
        • Eurofins bioskin GmbH
      • Heidelberg, Německo, 69120
        • Universitaetsklinikum Heidelberg
      • Mahlow, Německo, 15831
        • Hautarztpraxis
      • Mainz, Německo, 55131
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
      • Merzig, Německo, 66663
        • Hautmedizin Saar Science Hms GmbH
      • Münster, Německo, 48149
        • Universitaetsklinikum Muenster
      • Oldenburg, Německo, 26133
        • Klinikum Oldenburg
      • Witten, Německo, 58453
        • Hautarztpraxis 1
      • Wuppertal, Německo, 42287
        • CentroDerm GmbH
  • Polsko
      • Bialystok, Polsko, 15 797
        • RENEW Clinic
      • Katowice, Polsko, 40 568
        • Care Clinic
      • Katowice, Polsko, 40 611
        • Centrum Medyczne Angelius Provita
      • Kielce, Polsko, 25-316
        • Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
      • Krakow, Polsko, 30-002
        • SGD s.c.
      • Krakow, Polsko, 30-303
        • Krakowskie Centrum Badan Klinicznych
      • Krakow, Polsko, 30-348
        • Jagiellonskie Centrum Innowacji
      • Krakow, Polsko, 31 559
        • Diamond Clinic
      • Olsztyn, Polsko, 10-117
        • Etyka Osrodek Badan Klinicznych
      • Warsaw, Polsko, 02-962
        • Royalderm Agnieszka Nawrocka
      • Warsaw, Polsko, 02 661
        • Carpe Diem Centrum Medycyny Estetycznej
      • Warsaw, Polsko, 02 672
        • Synexus Polska Sp z o o Oddzial w Warszawie
      • Wroclaw, Polsko, 51 685
        • WroMedica I Bielicka A Strzalkowska s c
  • Rumunsko
      • Cluj-Napoca, Rumunsko, 400105
        • Cabinet Medical Dermato-Venerologie
      • Craiova, Rumunsko, 200541
        • Centrul Medical Vitaplus
      • Craiova, Rumunsko, 200642
        • Spitalul Clinic Judetean de Urgenta
      • Iași, Rumunsko, 700381
        • Sc Iasiprest Srl
      • Oradea, Rumunsko, 410167
        • Spitalul Clinic Judetean de Urgenta Bihor
      • Timișoara, Rumunsko, 300757
        • New Derm Clinic
      • Târgu Mureş, Rumunsko, 540342
        • Spitalul Clinic Judetean Mures
  • Spojené státy
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85032
        • Alliance Dermatology and MOHS Center P C
    • California
      • Encinitas, California, Spojené státy, 92024
        • California Dermatology & Clinical Research Institute
      • Encino, California, Spojené státy, 91436
        • T Joseph Raoof Md Inc
      • Fresno, California, Spojené státy, 93701
        • UCSF Fresno
      • Los Angeles, California, Spojené státy, 90056
        • Wallace Medical Group, Inc
      • Los Angeles, California, Spojené státy, 90024
        • University of California Los Angeles - Division of Dermatology
      • Oceanside, California, Spojené státy, 92056
        • Dermatologist Medical Group of North County, Inc.
    • Florida
      • Miami, Florida, Spojené státy, 33155
        • Bioclinical Research Alliance Inc.
      • Miami, Florida, Spojené státy, 33133
        • Miami Dermatology And Laser Institute
      • Tampa, Florida, Spojené státy, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Douglasville, Georgia, Spojené státy, 30135
        • Southeast Dermatology Specialists
    • Illinois
      • Rolling Meadows, Illinois, Spojené státy, 60008
        • Arlington Dermatology
    • Kentucky
      • Louisville, Kentucky, Spojené státy, 40217
        • Skin Sciences, PLLC
      • Owensboro, Kentucky, Spojené státy, 42301
        • Qualmedica Research
    • Maryland
      • Rockville, Maryland, Spojené státy, 20850
        • DermAssociates, PC
    • Massachusetts
      • Brighton, Massachusetts, Spojené státy, 02135
        • Metro Boston Clinical Partners
      • Methuen, Massachusetts, Spojené státy, 01844
        • ActivMed Practices and Research
    • Michigan
      • Ann Arbor, Michigan, Spojené státy, 48109
        • University of Michigan
      • Bay City, Michigan, Spojené státy, 48706
        • Great Lakes Research Group
      • Caledonia, Michigan, Spojené státy, 49316
        • The Derm Institute of West Michigan
      • Canton, Michigan, Spojené státy, 48187
        • Hamzavi Dermatology
      • Troy, Michigan, Spojené státy, 48084
        • Somerset Skin Centre
    • Missouri
      • Kirksville, Missouri, Spojené státy, 63501
        • Cleaver Dermatology
    • Ohio
      • Bexley, Ohio, Spojené státy, 43209
        • Bexley Dermatology Research
    • Oklahoma
      • Tulsa, Oklahoma, Spojené státy, 74137
        • Essential Medical Research
    • Oregon
      • Portland, Oregon, Spojené státy, 97210-2996
        • Oregon Dermatology & Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy, 19103
        • Paddington Testing Co, Inc.
    • South Carolina
      • Charleston, South Carolina, Spojené státy, 29407
        • Clinical Research Center of the Carolinas LLC
      • Greenville, South Carolina, Spojené státy, 29615
        • Palmetto Clinical Trial Services, LLC
    • Texas
      • Arlington, Texas, Spojené státy, 76011
        • Arlington Research Center, Inc.
      • Dallas, Texas, Spojené státy, 75390
        • UT Southwestern Medical Center
      • San Antonio, Texas, Spojené státy, 78229
        • Dermatology Clinical Research Center of San Antonio
      • Webster, Texas, Spojené státy, 77598
        • Center for Clinical Studies
    • Utah
      • Bountiful, Utah, Spojené státy, 84010
        • Cope Family Medicine - Ogden Clinic
      • Springville, Utah, Spojené státy, 84663
        • Springville Dermatology CCT Research
      • West Valley City, Utah, Spojené státy, 84120
        • Kalo Clinical Research
    • Virginia
      • Norfolk, Virginia, Spojené státy, 23502
        • Virginia Dermatology Skin Cancer Center Pllc
  • Tchaj-wan
      • Kaohsiung City, Tchaj-wan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Tchaj-wan, 80756
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Taichung, Tchaj-wan, 40705
        • Taichung Veterans General Hospital
      • Taichung, Tchaj-wan, 40201
        • Chung Shan Medical University Hospital
      • Tainan, Tchaj-wan, 710
        • National Cheng Kung University Hospital
      • Taipei, Tchaj-wan, 110
        • Taipei Medical University
      • Taipei, Tchaj-wan, 116
        • Taipei Municipal Wanfang Hospital
  • Španělsko
      • Alcorcón, Španělsko, 28922
        • Hosp. Univ. Fundacion Alcorcon
      • Badalona, Španělsko, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Španělsko, 08036
        • Hosp Clinic de Barcelona
      • Manises, Španělsko, 46940
        • Hosp. de Manises
      • Salamanca, Španělsko, 37007
        • Hosp Clinico Univ de Salamanca
      • Santiago de Compostela, Španělsko, 15702
        • Clinica Gaias
      • Santiago de Compostela, Španělsko, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Španělsko, 41009
        • Hosp. Virgen Macarena
      • Seville, Španělsko, 41014
        • Hosp. Ntra. Sra. de Valme
      • Villajoyosa, Španělsko, 03570
        • Hosp. de La Marina Baixa
      • Zaragoza, Španělsko, 50009
        • Hosp. Clinico Univ. Lozano Blesa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

  • Diagnostika plakové psoriázy, s psoriatickou artritidou (PsA) nebo bez ní, po dobu alespoň 26 týdnů před prvním podáním studijní intervence
  • Celková plocha povrchu těla (BSA) větší nebo rovna (>=)10 procentům (%) při screeningu a výchozí hodnotě
  • Celková plocha psoriázy a index závažnosti (PASI) >=12 při screeningu a výchozí hodnotě
  • Celkové globální hodnocení zkoušejícího (IGA) >=3 při screeningu a výchozí hodnotě
  • Kandidát na fototerapii nebo systémovou léčbu ložiskové psoriázy

Kritéria vyloučení:

  • Neplaková forma psoriázy (například erytrodermická, guttální nebo pustulózní)
  • Současná psoriáza vyvolaná léky (například nový nástup psoriázy nebo exacerbace psoriázy z betablokátorů, blokátorů kalciových kanálů nebo lithia)
  • Současná diagnóza nebo známky nebo příznaky závažných, progresivních nebo nekontrolovaných renálních, jaterních, srdečních, cévních, plicních, gastrointestinálních, endokrinních, neurologických, hematologických, revmatologických, psychiatrických nebo metabolických poruch
  • Známé alergie, přecitlivělost nebo intolerance na JNJ-77242113 nebo jeho pomocné látky
  • Velký chirurgický zákrok (například vyžadující celkovou anestezii) během 8 týdnů před screeningem, nebo se plně nezotaví po chirurgickém zákroku nebo má chirurgický zákrok naplánovaný během doby, kdy se očekává účast účastníka ve studii

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: JNJ-77242113
Účastníci dostanou JNJ-77242113 od týdne 0 do týdne 156 a deukravacitinib odpovídající placebo od týdne 0 do týdne 24.
Lék: JNJ-77242113
JNJ-77242113 bude podáván orálně.
Lék: Deukravacitinib odpovídající placebu
Deukravacitinib odpovídající placebo bude podáváno perorálně.
Komparátor placeba: Placebo
Účastníci obdrží odpovídající placebo pro JNJ-77242113 od týdne 0 do týdne 16, odpovídající placebo pro deukravacitinib od týdne 0 do týdne 24 a JNJ-77242113 od týdne 16 do týdne 156.
Lék: JNJ-77242113
JNJ-77242113 bude podáván orálně.
Lék: JNJ-77242113 Odpovídající placebo
JNJ-77242113 odpovídající placebo bude podáváno orálně.
Lék: Deukravacitinib odpovídající placebu
Deukravacitinib odpovídající placebo bude podáváno perorálně.
Aktivní komparátor: Deukravacitinib
Účastníci budou dostávat deukravacitinib od týdne 0 do týdne 24 a odpovídající placebo pro JNJ-77242113 od týdne 0 do týdne 24 a JNJ-77242113 od týdne 24 do týdne 156.
Lék: JNJ-77242113
JNJ-77242113 bude podáván orálně.
Lék: JNJ-77242113 Odpovídající placebo
JNJ-77242113 odpovídající placebo bude podáváno orálně.
Lék: Deukravacitinib
Deukravacitinib bude podáván perorálně.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Změna od výchozí hodnoty v celkovém skóre PASI v týdnu 16
Časové okno: Výchozí hodnota (týden 0), týden 16
Změna oproti výchozí hodnotě v celkovém skóre PASI v týdnu 16 byla hlášena. PASI byl systém používaný pro hodnocení a klasifikaci závažnosti psoriatických lézí a jejich odpovědi na léčbu. V systému PASI bylo tělo rozděleno do 4 oblastí: hlava, trup, horní končetiny a dolní končetiny. Každá z těchto oblastí byla hodnocena a bodována samostatně pro zarudnutí, zatvrdnutí a šupinatění, přičemž každý z těchto příznaků byl hodnocen na stupnici od 0 do 4 (0 = žádný, 1 = mírný, 2 = střední, 3 = těžký a 4 = velmi těžký) a rozsah postižení od 0 (naznačoval žádné postižení) do 6 (90 % - 100 % postižení). PASI vytvořil číselné celkové skóre, které se mohlo pohybovat od 0 (žádná psoriáza) do 72 (maximální psoriáza). Vyšší skóre naznačovalo větší závažnost psoriázy. Výchozí hodnota byla definována jako nejbližší měření provedené před nebo v době data první podání studijního léku.
Výchozí hodnota (týden 0), týden 16
Percentage of Participants Who Achieved PASI 100 Response at Week 16
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: From Week 24 up to Week 160
From Week 24 up to Week 160
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Časové okno: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Časové okno: From Week 0 to Week 160
From Week 0 to Week 160

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Janssen Research & Development, LLC

Vyšetřovatelé

  • Ředitel studie: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

9. března 2024

Primární dokončení (Aktuální)

15. listopadu 2024

Dokončení studie (Odhadovaný)

20. září 2027

Termíny zápisu do studia

První předloženo

15. ledna 2024

První předloženo, které splnilo kritéria kontroly kvality

15. ledna 2024

První zveřejněno (Aktuální)

24. ledna 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

25. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 77242113PSO3004 (Jiný identifikátor: Janssen Research & Development, LLC)
  • 2023-507039-39-00 (Identifikátor registru: EUCT number)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Zásady sdílení dat Janssen Pharmaceutical Companies of Johnson & Johnson jsou k dispozici na www.janssen.com/clinical-trials/transparency. Jak je uvedeno na této stránce, žádosti o přístup k datům studie lze podávat prostřednictvím stránky projektu Yale Open Data Access (YODA) na adrese yoda.yale.edu

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Plaková psoriáza

Klinické studie na JNJ-77242113

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Netherlands

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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