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Eine Studie zu JNJ-77242113 zur Behandlung von Teilnehmern mit mittelschwerer bis schwerer Plaque-Psoriasis (ICONIC-ADVANCE 2)

2. Juli 2026 aktualisiert von: Janssen Research & Development, LLC

Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte und mit Deucravacitinib aktive Vergleichsstudie der Phase 3 zur Bewertung der Wirksamkeit und Sicherheit von JNJ-77242113 zur Behandlung von Teilnehmern mit mittelschwerer bis schwerer Plaque-Psoriasis

Der Zweck der Studie besteht darin, zu bewerten, wie wirksam JNJ-77242113 bei Teilnehmern mit mittelschwerer bis schwerer Plaque-Psoriasis im Vergleich zu Placebo und Deucravacitinib ist.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

731

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Diagnose von Plaque-Psoriasis mit oder ohne Psoriasis-Arthritis (PsA) für mindestens 26 Wochen vor der ersten Verabreichung der Studienintervention
  • Gesamtkörperoberfläche (BSA) größer oder gleich (>=) 10 Prozent (%) beim Screening und bei Studienbeginn
  • Gesamtfläche und Schweregrad der Psoriasis (PASI) >=12 beim Screening und bei Studienbeginn
  • Total Investigator Global Assessment (IGA) >=3 beim Screening und bei Studienbeginn
  • Kandidat für Phototherapie oder systemische Behandlung von Plaque-Psoriasis

Ausschlusskriterien:

  • Nichtplaque-Form der Psoriasis (z. B. erythrodermische, guttata oder pustulöse)
  • Aktuelle medikamenteninduzierte Psoriasis (z. B. ein neuer Ausbruch der Psoriasis oder eine Verschlimmerung der Psoriasis durch Betablocker, Kalziumkanalblocker oder Lithium)
  • Eine aktuelle Diagnose oder Anzeichen oder Symptome schwerer, fortschreitender oder unkontrollierter Nieren-, Leber-, Herz-, Gefäß-, Lungen-, Magen-Darm-, endokriner, neurologischer, hämatologischer, rheumatologischer, psychiatrischer oder metabolischer Störungen
  • Bekannte Allergien, Überempfindlichkeit oder Unverträglichkeit gegenüber JNJ-77242113 oder seinen Hilfsstoffen
  • Größerer chirurgischer Eingriff (der beispielsweise eine Vollnarkose erfordert) innerhalb von 8 Wochen vor dem Screening, oder Sie haben sich nicht vollständig von dem chirurgischen Eingriff erholt oder ein chirurgischer Eingriff ist während des Zeitraums geplant, in dem der Teilnehmer voraussichtlich an der Studie teilnehmen wird

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: JNJ-77242113
Die Teilnehmer erhalten von Woche 0 bis Woche 156 JNJ-77242113 und von Woche 0 bis Woche 24 das passende Placebo Deucravacitinib.
Arzneimittel: JNJ-77242113
JNJ-77242113 wird oral verabreicht.
Arzneimittel: Deucravacitinib passendes Placebo
Das passende Placebo zu Deucravacitinib wird oral verabreicht.
Placebo-Komparator: Placebo
Die Teilnehmer erhalten von Woche 0 bis Woche 16 das passende Placebo für JNJ-77242113, von Woche 0 bis Woche 24 das passende Placebo für Deucravacitinib und von Woche 16 bis Woche 156 das passende Placebo für JNJ-77242113.
Arzneimittel: JNJ-77242113
JNJ-77242113 wird oral verabreicht.
Arzneimittel: JNJ-77242113 Passendes Placebo
Das zu JNJ-77242113 passende Placebo wird oral verabreicht.
Arzneimittel: Deucravacitinib passendes Placebo
Das passende Placebo zu Deucravacitinib wird oral verabreicht.
Aktiver Komparator: Deucravacitinib
Die Teilnehmer erhalten Deucravacitinib von Woche 0 bis Woche 24 und das passende Placebo für JNJ-77242113 von Woche 0 bis Woche 24 und JNJ-77242113 von Woche 24 bis Woche 156.
Arzneimittel: JNJ-77242113
JNJ-77242113 wird oral verabreicht.
Arzneimittel: JNJ-77242113 Passendes Placebo
Das zu JNJ-77242113 passende Placebo wird oral verabreicht.
Arzneimittel: Deucravacitinib
Deucravacitinib wird oral verabreicht.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Veränderung vom Ausgangswert im PASI-Gesamtscore in Woche 16
Zeitfenster: Ausgangswert (Woche 0), Woche 16
Die Veränderung gegenüber dem Ausgangswert in der PASI-Gesamtpunktzahl in Woche 16 wurde berichtet. Der PASI war ein System zur Beurteilung und Einstufung der Schwere von psoriatischen Läsionen und ihres Ansprechens auf die Therapie. Im PASI-System wurde der Körper in 4 Regionen eingeteilt: Kopf, Rumpf, obere Extremitäten und untere Extremitäten. Jeder dieser Bereiche wurde separat hinsichtlich Erythem, Induration und Schuppung beurteilt und bewertet, wobei jeder Parameter auf einer Skala von 0 bis 4 bewertet wurde (0 = keine, 1 = leicht, 2 = mäßig, 3 = schwer und 4 = sehr schwer) und das Ausmaß der Beteiligung von 0 (keine Beteiligung) bis 6 (90 % - 100 % Beteiligung). Der PASI erzeugte eine numerische Gesamtpunktzahl, die von 0 (keine Psoriasis) bis 72 (maximale Psoriasis) reichen konnte. Ein höherer Wert deutete auf eine größere Schwere der Psoriasis hin. Der Ausgangswert wurde als die nächste Messung definiert, die vor oder zum Zeitpunkt des ersten Verabreichungsdatums des Studienmedikaments durchgeführt wurde.
Ausgangswert (Woche 0), Woche 16
Percentage of Participants Who Achieved PASI 100 Response at Week 16
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From Week 24 up to Week 160
From Week 24 up to Week 160
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Zeitfenster: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Zeitfenster: From Week 0 to Week 160
From Week 0 to Week 160

Mitarbeiter und Ermittler

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Sponsor

Janssen Research & Development, LLC

Ermittler

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

Publikationen und hilfreiche Links

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Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. März 2024

Primärer Abschluss (Tatsächlich)

15. November 2024

Studienabschluss (Geschätzt)

20. September 2027

Studienanmeldedaten

Zuerst eingereicht

15. Januar 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Januar 2024

Zuerst gepostet (Tatsächlich)

24. Januar 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 77242113PSO3004 (Andere Kennung: Janssen Research & Development, LLC)
  • 2023-507039-39-00 (Registrierungskennung: EUCT number)

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Beschreibung des IPD-Plans

Die Datenaustauschrichtlinie der Janssen Pharmaceutical Companies of Johnson & Johnson ist unter www.janssen.com/clinical-trials/transparency verfügbar. Wie auf dieser Website angegeben, können Anträge auf Zugriff auf die Studiendaten über die Website des Yale Open Data Access (YODA)-Projekts unter yoda.yale.edu eingereicht werden

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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