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Badanie JNJ-77242113 dotyczące leczenia uczestników chorych na łuszczycę plackowatą o nasileniu umiarkowanym do ciężkiego (ICONIC-ADVANCE 2)

2 lipca 2026 zaktualizowane przez: Janssen Research & Development, LLC

Wieloośrodkowe, randomizowane badanie III fazy z podwójnie ślepą próbą, kontrolowane placebo i kontrolowane aktywnym komparatorem deukrawacytynibu, mające na celu ocenę skuteczności i bezpieczeństwa JNJ-77242113 w leczeniu uczestników z umiarkowaną do ciężkiej łuszczycą plackowatą

Celem badania jest ocena skuteczności preparatu JNJ-77242113 u uczestników chorych na łuszczycę plackowatą o nasileniu umiarkowanym do ciężkiego w porównaniu z placebo i deukrawacytynibem.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

731

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Rozpoznanie łuszczycy plackowatej z lub bez łuszczycowego zapalenia stawów (ŁZS) przez co najmniej 26 tygodni przed pierwszym podaniem badanego leku
  • Całkowita powierzchnia ciała (BSA) większa lub równa (>=) 10 procent (%) w badaniu przesiewowym i na początku
  • Całkowita powierzchnia łuszczycy i wskaźnik nasilenia (PASI) >=12 w badaniu przesiewowym i na początku badania
  • Całkowita ogólna ocena badacza (IGA) >=3 podczas badania przesiewowego i na początku badania
  • Kandydat do fototerapii lub leczenia systemowego łuszczycy plackowatej

Kryteria wyłączenia:

  • Niepłytkowa postać łuszczycy (na przykład erytrodermia, kropelkowata lub krostkowa)
  • Aktualna łuszczyca polekowa (na przykład nowy początek łuszczycy lub zaostrzenie łuszczycy po zastosowaniu beta-blokerów, blokerów kanału wapniowego lub litu)
  • Aktualna diagnoza lub oznaki lub objawy ciężkich, postępujących lub niekontrolowanych zaburzeń nerek, wątroby, serca, naczyń, płuc, przewodu pokarmowego, endokrynologii, neurologii, hematologii, reumatologii, psychiatrii lub metabolizmu
  • Znane alergie, nadwrażliwość lub nietolerancja na JNJ-77242113 lub jego substancje pomocnicze
  • Poważny zabieg chirurgiczny (na przykład wymagający znieczulenia ogólnego) w ciągu 8 tygodni przed badaniem przesiewowym lub nie nastąpi w pełni powrót do zdrowia po zabiegu chirurgicznym lub zabieg chirurgiczny jest zaplanowany w czasie, w którym uczestnik ma wziąć udział w badaniu

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: JNJ-77242113
Uczestnicy otrzymają JNJ-77242113 od tygodnia 0 do 156 tygodnia i deukrawacytynib odpowiadające placebo od tygodnia 0 do 24 tygodnia.
Lek: JNJ-77242113
JNJ-77242113 będzie podawany doustnie.
Lek: Deukrawacytynib Dopasowanie Placebo
Placebo odpowiadające deukrawacytynibowi będzie podawane doustnie.
Komparator placebo: Placebo
Uczestnicy otrzymają odpowiadające placebo dla leku JNJ-77242113 od 0 do 16 tygodnia, pasujące placebo dla deukrawacytynibu od tygodnia 0 do 24 tygodnia i JNJ-77242113 od 16 do 156 tygodnia.
Lek: JNJ-77242113
JNJ-77242113 będzie podawany doustnie.
Lek: JNJ-77242113 Dopasowane placebo
Odpowiednie placebo JNJ-77242113 będzie podawane doustnie.
Lek: Deukrawacytynib Dopasowanie Placebo
Placebo odpowiadające deukrawacytynibowi będzie podawane doustnie.
Aktywny komparator: Deukrawacytynib
Uczestnicy otrzymają deukrawacytynib od tygodnia 0 do tygodnia 24 oraz odpowiadające placebo JNJ-77242113 od tygodnia 0 do tygodnia 24 i JNJ-77242113 od tygodnia 24 do tygodnia 156.
Lek: JNJ-77242113
JNJ-77242113 będzie podawany doustnie.
Lek: JNJ-77242113 Dopasowane placebo
Odpowiednie placebo JNJ-77242113 będzie podawane doustnie.
Lek: Deukrawacytynib
Deukrawacytynib będzie podawany doustnie.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Zmiana w stosunku do wartości wyjściowej w ogólnej punktacji PASI w tygodniu 16
Ramy czasowe: Punkt wyjściowy (Tydzień 0), Tydzień 16
Zmianę od wartości wyjściowej w całkowitym wyniku PASI w 16. tygodniu zgłoszono. PASI był systemem stosowanym do oceny i klasyfikacji ciężkości zmian łuszczycowych oraz ich odpowiedzi na terapię. W systemie PASI ciało podzielono na 4 regiony: głowę, tułów, kończyny górne i kończyny dolne. Każdy z tych obszarów oceniano i punktowano osobno pod kątem rumienia, nacieku i złuszczania, które oceniano w skali od 0 do 4 (0 = brak, 1 = niewielki, 2 = umiarkowany, 3 = ciężki i 4 = bardzo ciężki) oraz zakresu zajęcia od 0 (brak zajęcia) do 6 (90% - 100% zajęcia). PASI dawał liczbowy wynik całkowity, który mógł wynosić od 0 (brak łuszczycy) do 72 (maksymalna łuszczyca). Wyższy wynik wskazywał na większą ciężkość łuszczycy. Wartość wyjściową zdefiniowano jako najbliższy pomiar wykonany przed lub w dniu podania pierwszej dawki leku w badaniu.
Punkt wyjściowy (Tydzień 0), Tydzień 16
Percentage of Participants Who Achieved PASI 100 Response at Week 16
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: From Week 24 up to Week 160
From Week 24 up to Week 160
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Ramy czasowe: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Ramy czasowe: From Week 0 to Week 160
From Week 0 to Week 160

Współpracownicy i badacze

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Sponsor

Janssen Research & Development, LLC

Śledczy

  • Dyrektor Studium: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

9 marca 2024

Zakończenie podstawowe (Rzeczywisty)

15 listopada 2024

Ukończenie studiów (Szacowany)

20 września 2027

Daty rejestracji na studia

Pierwszy przesłany

15 stycznia 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 stycznia 2024

Pierwszy wysłany (Rzeczywisty)

24 stycznia 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 77242113PSO3004 (Inny identyfikator: Janssen Research & Development, LLC)
  • 2023-507039-39-00 (Identyfikator rejestru: EUCT number)

Plan dla danych uczestnika indywidualnego (IPD)

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Opis planu IPD

Polityka udostępniania danych Janssen Pharmaceutical Companies należącej do Johnson & Johnson jest dostępna pod adresem www.janssen.com/clinical-trials/transparency. Jak wskazano na tej stronie, wnioski o dostęp do danych z badania można składać za pośrednictwem witryny projektu Yale Open Data Access (YODA) pod adresem yoda.yale.edu

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Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

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Nie

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