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Eine Studie zu JNJ-77242113 zur Behandlung von Teilnehmern mit Plaque-Psoriasis, die bestimmte Bereiche (Kopfhaut, Genitalbereich und/oder Handflächen und Fußsohlen) betrifft. (ICONIC-TOTAL)

27. August 2026 aktualisiert von: Janssen Research & Development, LLC

Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Phase-3-Studie zur Bewertung der Wirksamkeit und Sicherheit von JNJ-77242113 zur Behandlung von Teilnehmern mit Plaque-Psoriasis in bestimmten Bereichen

Der Zweck der Studie besteht darin, herauszufinden, wie wirksam JNJ-77242113 bei Teilnehmern mit Plaque-Psoriasis ist, die bestimmte Bereiche (Kopfhaut, Genitalbereich und/oder Handflächen und Fußsohlen) betrifft.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

311

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

  • Argentinien
      • Buenos Aires, Argentinien, C1417EYG
        • Centro Privado de Medicina Familiar
      • Buenos Aires, Argentinien, C1061AAS
        • CIPREC
      • CABA, Argentinien, C1012AAY
        • CONEXA Investigacion Clinica S.A.
      • Caba, Argentinien, C1060ABN
        • CEDIC Centro de Investigación Clínica
  • Deutschland
      • Berlin, Deutschland, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Berlin, Deutschland, 13627
        • CRS Clinical Research Services Berlin GMBH
      • Bochum, Deutschland, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, Deutschland, 64283
        • Rosenpark Research GmbH
      • Dresden, Deutschland, 01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Frankfurt am Main, Deutschland, 60590
        • Universitaetsklinikum Frankfurt
      • Hamburg, Deutschland, 20354
        • Dermatologikum Hamburg Gmbh
      • Schwerin, Deutschland, 19055
        • Klinische Forschung Schwerin GmbH
      • Witten, Deutschland, 58453
        • Hautarztpraxis 2
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1C3
        • Alberta Dermasurgery Centre
    • Ontario
      • Markham, Ontario, Kanada, L3P 1X3
        • Lynderm Research Inc.
      • Peterborough, Ontario, Kanada, K9J 5K2
        • SKiN Centre for Dermatology
      • Richmond Hill, Ontario, Kanada, L4B1L1
        • York Dermatology Clinic and Research Centre
    • Quebec
      • Montreal, Quebec, Kanada, H2X 2V1
        • Innovaderm Research Inc.
      • Québec, Quebec, Kanada, G1V 4X7
        • Centre Dermatologique
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7K 2C1
        • Skinsense Medical Research
  • Polen
      • Bialystok, Polen, 15-351
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok, Polen, 15-375
        • Specderm Poznanska sp j
      • Krakow, Polen, 31-411
        • Centrum Medyczne PROMED
      • Krakow, Polen, 30 438
        • Centrum Medyczne dr Rajzer Sp z o o
      • Krakow, Polen, 30-002
        • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
      • Lodz, Polen, 90-265
        • Dermed Centrum Medyczne Sp z o o
      • Osielsko, Polen, 86031
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
      • Poznan, Polen, 61 731
        • Clinical Research Center sp z o o MEDIC R s k
      • Poznan, Polen, 60 529
        • SOLUMED Centrum Medyczne
      • Warsaw, Polen, 02 953
        • Klinika Ambroziak Dermatologia
      • Warsaw, Polen, 01 817
        • Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
      • Wroclaw, Polen, 52 416
        • Centrum Medyczne Oporow
      • Wroclaw, Polen, 51 685
        • Wro Medica
  • Spanien
      • Badalona, Spanien, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spanien, 08003
        • Hosp. Del Mar
      • Esplugues de Llobregat, Spanien, 08950
        • Hosp. Sant Joan de Deu
      • Granada, Spanien, 18016
        • Hosp. Univ. San Cecilio
      • Madrid, Spanien, 28041
        • Hosp. Univ. 12 de Octubre
      • Manises, Spanien, 46940
        • Hosp. de Manises
      • Seville, Spanien, 41009
        • Hosp. Virgen Macarena
      • Valencia, Spanien, 46026
        • Hosp. Univ. I Politecni La Fe
  • Südkorea
      • Busan, Südkorea, 49241
        • Pusan National University Hospital
      • Seongnam-si, Südkorea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Südkorea, 03080
        • Seoul National University Hospital
      • Seoul, Südkorea, 08308
        • Korea University Guro Hospital
      • Seoul, Südkorea, 05030
        • Konkuk University Medical Center
  • Taiwan
      • Hsinchu, Taiwan, 30059
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 33382
        • Linkou Chang Gung Memorial Hospital
  • Türkei (türkiye)
      • Konya, Türkei (türkiye), 42080
        • Necmettin Erbakan University Meram Medical Faculty
      • Samsun, Türkei (türkiye), 55270
        • Ondokuz Mayis University
      • Trabzon, Türkei (türkiye), 61080
        • Karadeniz Teknik University Medical Faculty
  • Ungarn
      • Borgyogyaszati Klinika, Ungarn, 7632
        • Pécsi Tudományegyetem
      • Budapest, Ungarn, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Debrecen, Ungarn, 4031
        • Derma-B Kft
      • Szeged, Ungarn, 6720
        • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
      • Szolnok, Ungarn, 5000
        • Allergo-Derm Bakos Kft.
      • Veszprém, Ungarn, 8200
        • Medmare Egeszsegugyi Es Szolgaltato Bt.
  • Vereinigte Staaten
    • Arizona
      • Scottsdale, Arizona, Vereinigte Staaten, 85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fort Smith, Arkansas, Vereinigte Staaten, 72916
        • Johnson Dermatology
    • California
      • Encinitas, California, Vereinigte Staaten, 92024
        • California Dermatology & Clinical Research Institute
    • Florida
      • Tampa, Florida, Vereinigte Staaten, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Alpharetta, Georgia, Vereinigte Staaten, 30022
        • Hamilton Research LLC
    • Illinois
      • Rolling Meadows, Illinois, Vereinigte Staaten, 60008
        • Arlington Dermatology
      • West Dundee, Illinois, Vereinigte Staaten, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46250
        • Dawes Fretzin Clinical Research Group LLC
      • Plainfield, Indiana, Vereinigte Staaten, 46168
        • Indiana Clinical Trial Center
    • Louisiana
      • Lake Charles, Louisiana, Vereinigte Staaten, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Beverly, Massachusetts, Vereinigte Staaten, 01915
        • Allcutis Research 1
    • Michigan
      • Fort Gratiot, Michigan, Vereinigte Staaten, 48059
        • Hamzavi Dermatology
    • Minnesota
      • New Brighton, Minnesota, Vereinigte Staaten, 55112
        • Minnesota Clinical Study Center
    • Missouri
      • Saint Joseph, Missouri, Vereinigte Staaten, 64506
        • Medisearch Clinical Trials
    • Nebraska
      • Omaha, Nebraska, Vereinigte Staaten, 68144
        • Skin Specialists
    • New Jersey
      • East Windsor, New Jersey, Vereinigte Staaten, 08520
        • Schweiger Dermatology Group
    • Ohio
      • Boardman, Ohio, Vereinigte Staaten, 44512
        • Optima Research
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97210
        • Oregon Dermatology and Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19103
        • Paddington Testing Co, Inc.
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Arlington, Texas, Vereinigte Staaten, 76011
        • Arlington Research Center, inc.
      • Houston, Texas, Vereinigte Staaten, 77004
        • Center for Clinical Studies 1
      • Pflugerville, Texas, Vereinigte Staaten, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • Dermatology Clinical Research Center of San Antonio
      • San Antonio, Texas, Vereinigte Staaten, 78213
        • Progressive Clinical Research
      • Webster, Texas, Vereinigte Staaten, 77598
        • Center for Clinical Studies
    • Utah
      • Bountiful, Utah, Vereinigte Staaten, 84010
        • Cope Family Medicine - Ogden Clinic
    • Washington
      • Mill Creek, Washington, Vereinigte Staaten, 98012
        • Frontier Derm Partners CRO, LLC
  • Vereinigtes Königreich
      • Harrow, Vereinigtes Königreich, HA1 3UJ
        • London North West University Healthcare NHS Trust
      • Salford, Vereinigtes Königreich, M6 8HD
        • Salford Royal Hospital
      • Southampton, Vereinigtes Königreich, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust

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

  • Kind
  • 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
  • Kandidat für Phototherapie oder systemische Behandlung von Plaque-Psoriasis
  • Kriterien müssen erfüllt werden: Gesamtkörperoberfläche (BSA) größer oder gleich (>=) 1 Prozent (%) bei Screening und Studienbeginn und Prüfarzt-Globalbewertung (IGA) (insgesamt) >= 2 bei Screening und Studienbeginn und bei Mindestens einer der folgenden Punkte: Skalp-spezifischer Prüfer-Global-Assessment-Score (ss-IGA) >=3 bei Screening und Studienbeginn und/oder statischer Arzt-Global-Assessment der Genitalien (sPGA-G) >=3 bei Screening und Studienbeginn und/oder oder ärztliche Gesamtbeurteilung der Hände und Füße (hf-PGA)-Score >=3 beim Screening und bei Studienbeginn
  • Hat auf mindestens eine topische Therapie (z. B. Kortikosteroide, Calcineurin-Inhibitoren und/oder Vitamin-D-Analoga) zur Behandlung von Psoriasis nicht angesprochen
  • Bestätigung von Plaque-Psoriasis in einem nicht speziellen Bereich (z. B. Bereiche ohne Kopfhaut, Genitalbereich, Palmoplantar) beim Screening und bei Studienbeginn

Ausschlusskriterien:

  • Nichtplaque-Form der Psoriasis (z. B. erythrodermische, guttierende oder pustulöse)
  • Andere Dermatosen als Plaque-Psoriasis (z. B. Kontaktdermatitis) oder palmoplantare Pustulose des palmoplantaren Bereichs (wenn hf-PGA >=3 zu Studienbeginn)
  • 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

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 JNJ-77242113 von Woche 0 bis Woche 156.
Arzneimittel: JNJ-77242113
JNJ-77242113 wird oral verabreicht.
Placebo-Komparator: Placebo
Die Teilnehmer erhalten von Woche 0 bis Woche 16 ein Placebo und danach von Woche 16 bis Woche 156 JNJ-77242113.
Arzneimittel: Placebo
Placebo wird oral verabreicht.
Arzneimittel: JNJ-77242113
JNJ-77242113 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 a 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, 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,>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 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.
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
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 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
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
Change From Baseline in PSSD Sign Score at Week 16
Zeitfenster: Baseline (Week 0), Week 16
Change from baseline in PSSD sign score 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
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 i.e. 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/at the time of first study drug administration date.
Baseline (Week 0), Week 16
Number of Participants With Adverse Events (AEs)
Zeitfenster: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Serious Adverse Events (SAEs)
Zeitfenster: From Week 0 to Week 160
From Week 0 to Week 160
Percentage of Participants Who Achieved a Scalp Specific (ss)-IGA Score of 0 or 1 at Week 16 Among Participants With a Baseline Ss-IGA Score >=3
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 Scalp Severity Index (PSSI) 90 at Week 16 Among Participants With a Baseline Ss-IGA Score >=3
Zeitfenster: Week 16
PSSI 90 response is defined as a percentage of participants who achieved at least 90% improvement from baseline in the PSSI score. PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). Higher scores indicating more severe symptoms. Baseline=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 at Week 16 Among Participants With a Baseline sPGA Score >=3
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 at Week 16 Among Participants With a Baseline Hf-PGA Score >=3
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) among participants. 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 an 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 Psoriasis Symptom and Signs Diary (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 >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a Baseline PSSD Itch Score >=4
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 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.
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 sPGA-G Score >=3 and a Baseline GenPs-SFQ Item 2 Score >=2
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). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis.
Week 16
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 16 Among Participants With a Baseline Ss-IGA Score >=3 and a Baseline Scalp Itch NRS Score >=4
Zeitfenster: Week 16
The Scalp Itch NRS is a single item instrument that evaluates the severity of scalp itch in adult and adolescent populations over the past 24 hours. The instrument uses an NRS score ranging from 0 (no scalp itch) to 10 (worst scalp itch imaginable), with higher scores indicative of greater symptom 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 >=4-Point Improvement From Baseline in Genital Psoriasis Symptoms Score (GPSS) Genital Itch NRS Score at Week 16 Among Participants With a Baseline sPGA-G Score >=3 and a Baseline GPSS Genital Itch NRS Score >=4
Zeitfenster: Week 16
The GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent is asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an NRS of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, ranging from 0 (no severity) to 10 (worst imaginable severity). Higher scores indicate greater itch intensity. 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 Area and Severity Index (PASI) 90 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 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 16
Percentage of Participants Who Achieved PASI 75 at Week 16
Zeitfenster: Week 16
Percentage of participants who achieved PASI-75 score (>=75% 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 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 16
Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (fPGA) 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. 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 PSSD Symptoms Score of 0 at Week 8 Among Participants With a Baseline PSSD Symptom Score >0
Zeitfenster: Week 8
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 8
Change From Baseline in PSSD Symptoms 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
Percentage of Participants Achieving >=4-Point Improvement From Baseline in PSSD Itch Score at Week 4 Among Participants With a Baseline Itch Score >=4
Zeitfenster: Week 4
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.
Week 4
Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline PSSD 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 Children's Dermatological Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 Among Adolescent Participants With a Baseline CDLQI Score >1
Zeitfenster: Week 16
The CDLQI was an adapted version of the DLQI for the pediatric population and was utilized in the adolescent population in this study. The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. The instrument is designed for use in children, is self-explanatory and can be simply handed to the participant who asked to fill it in with the help of the child's parent or caregiver. 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 Domain Scores of the PROMIS-25 Pediatric Score at Week 16
Zeitfenster: Baseline (Week 0), Week 16
The PROMIS-25 was utilized in the adolescent population and is a 25-item generic HRQoL survey. Six PROMIS domains (physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference) are each assessed with 4 questions. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Higher score=worst pain. Raw scores for each domain were converted to T-scores using standardized score with a mean of 50 and a standard deviation (SD) of 10 with an observed range 20 to 80. For anxiety, depressive symptoms, fatigue, and pain interference, a negative change indicates an improvement while for physical function mobility and peer relationships, a positive change indicates an improvement. 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 Palmoplantar Quality of Life Instrument (ppQLI) Hands Score at Week 16 Among Participants With a Baseline Hf-PGA Score >=3
Zeitfenster: Baseline (Week 0), Week 16
The ppQLI assesses impact on patient quality of life due to palmoplantar psoriasis over the past month in adult and adolescent populations. Sixteen items evaluate hand functionality, pain, and social impact due to psoriasis. Fourteen items evaluate foot functionality, pain, and physical limitations due to psoriasis. All items use verbal rating scales ranging from 1 to 5. The ppQLI yields a score for hands, ranging from 16 to 80, and a score for feet, ranging from 14 to 70. Higher score indicating 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.
Baseline (Week 0), Week 16
Change From Baseline in ppQLI Feet Score at Week 16 Among Participants With a Baseline Hf-PGA Score >=3
Zeitfenster: Baseline (Week 0), Week 16
The ppQLI assesses impact on patient quality of life due to palmoplantar psoriasis over the past month in adult and adolescent populations. Sixteen items evaluate hand functionality, pain, and social impact due to psoriasis. Fourteen items evaluate foot functionality, pain, and physical limitations due to psoriasis. All items use verbal rating scales ranging from 1 to 5. The ppQLI yields a score for hands, ranging from 16 to 80, and a score for feet, ranging from 14 to 70. Higher score indicating 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.
Baseline (Week 0), Week 16
Change From Baseline in Genital Psoriasis Symptoms Score (GPSS) Total Score at Week 16 Among Participants With a Baseline sPGA-G Score >=3
Zeitfenster: Baseline (Week 0), Week 16
The GPSS was a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom was indicated by selecting the number from an NRS of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, ranging from 0 (no severity) to 10 (worst imaginable severity). Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms). A negative change from baseline indicates an improvement in genital psoriasis symptoms. 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

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  • Studienleiter: Janssen Research &Development, LLC Clinical trial, Janssen Research & Development, LLC

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Haupttermine studieren

Studienbeginn (Tatsächlich)

12. Oktober 2023

Primärer Abschluss (Tatsächlich)

19. Juni 2024

Studienabschluss (Geschätzt)

17. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

18. Oktober 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Oktober 2023

Zuerst gepostet (Tatsächlich)

23. Oktober 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. August 2026

Zuletzt verifiziert

1. August 2026

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Andere Studien-ID-Nummern

  • 77242113PSO3003 (Andere Kennung: Janssen Research & Development, LLC)

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