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En undersøgelse af JNJ-77242113 hos unge og voksne deltagere med moderat til svær plakpsoriasis (ICONIC-LEAD)

4. juni 2026 opdateret af: Janssen Research & Development, LLC

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

Formålet med denne undersøgelse er at se, hvor effektiv JNJ-77242113 er hos deltagere med moderat til svær plakpsoriasis.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

684

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1417EYG
        • Centro Privado de Medicina Familiar
      • Buenos Aires, Argentina, C1406AGA
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • Buenos Aires, Argentina, C1426
        • Derma Internacional S A
      • CABA, Argentina, C1425DKG
        • Psoriahue
      • Mar del Plata, Argentina, B7600FYK
        • Centro de Investigaciones Medicas Mar Del Plata
      • Rosario, Argentina, S2000DBS
        • Instituto De Especialidades De La Salud SRL
      • San Fernando, Argentina, B1646
        • MR Medicina Reumatologica
  • Australien
      • East Melbourne, Australien, 3002
        • Dr Rodney Sinclair Pty Ltd
      • Melbourne, Australien, 3004
        • The Alfred Hospital
      • Miranda, Australien, 2228
        • Kingsway Dermatology & Aesthetics
      • Mitcham, Australien, 3132
        • ISHI dermatology
      • Parkville, Australien, 3050
        • Royal Melbourne Hospital
      • Woolloongabba, Australien, 4102
        • Veracity Clinical Research
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute Inc
      • Edmonton, Alberta, Canada, T5J 3S9
        • Rejuvenation Dermatology Clinic Edmonton Downtown
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih ho Hong Medical
    • Ontario
      • London, Ontario, Canada, N6H 5L5
        • Dr Wei Jing Loo Medicine Professional Corporation
      • London, Ontario, Canada, N5X 2P1
        • Mediprobe Research Inc.
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Ryan Clinical Research Inc
      • Toronto, Ontario, Canada, M3H 5Y8
        • Toronto Research Centre
      • Toronto, Ontario, Canada, M3B 0A7
        • Canadian Dermatology Center
      • Toronto, Ontario, Canada, M4C 1L1
        • Facet Dermatology
      • Windsor, Ontario, Canada, N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research Inc.
  • Det Forenede Kongerige
      • Harrow, Det Forenede Kongerige, HA1 3UJ
        • London North West University Healthcare NHS Trust
      • London, Det Forenede Kongerige, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Reading, Det Forenede Kongerige, RG1 5AN
        • Royal Berkshire Hospital
      • Salford, Det Forenede Kongerige, M6 8HD
        • Salford Royal Hospital
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Medical Dermatology Specialists
    • Arkansas
      • Fort Smith, Arkansas, Forenede Stater, 72916
        • Johnson Dermatology
    • California
      • Fountain Valley, California, Forenede Stater, 92708
        • First OC Dermatology
      • Fremont, California, Forenede Stater, 94538
        • Center for Dermatology Clinical Research
      • Sacramento, California, Forenede Stater, 95815
        • Integrative Skin Science and Research
      • San Diego, California, Forenede Stater, 92123
        • Rady Childrens Hospital San Diego
      • Santa Ana, California, Forenede Stater, 92701
        • Southern California Dermatology
      • Santa Monica, California, Forenede Stater, 90403
        • Clinical Science Institute
    • Florida
      • Miami, Florida, Forenede Stater, 33155
        • Bioclinical Research Alliance Inc.
      • North Miami Beach, Florida, Forenede Stater, 33162
        • Ziaderm Research LLC
      • Tampa, Florida, Forenede Stater, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Macon, Georgia, Forenede Stater, 31217
        • Skin Care Physicians of Georgia
    • Illinois
      • Rolling Meadows, Illinois, Forenede Stater, 60008
        • Arlington Dermatology
      • Skokie, Illinois, Forenede Stater, 60077
        • Endeavor Health
      • West Dundee, Illinois, Forenede Stater, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46250
        • Dawes Fretzin Clinical Research Group LLC
      • Plainfield, Indiana, Forenede Stater, 46168
        • Indiana Clinical Trial Center
    • Kentucky
      • Owensboro, Kentucky, Forenede Stater, 42301
        • Qualmedica Research
    • Louisiana
      • Lake Charles, Louisiana, Forenede Stater, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Beverly, Massachusetts, Forenede Stater, 01915
        • Allcutis Research 1
    • Michigan
      • Clarkston, Michigan, Forenede Stater, 48346
        • Michigan Center of Medical Research
    • Minnesota
      • New Brighton, Minnesota, Forenede Stater, 55112
        • Minnesota Clinical Study Center
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68144
        • Skin Specialists
    • New Hampshire
      • Portsmouth, New Hampshire, Forenede Stater, 03801
        • Allcutis Research
    • New Jersey
      • East Windsor, New Jersey, Forenede Stater, 08520
        • Schweiger Dermatology Group
    • New York
      • New York, New York, Forenede Stater, 10029
        • Icahn School of Medicine at Mt. Sinai
    • North Carolina
      • Wilmington, North Carolina, Forenede Stater, 28405
        • Wilmington Dermatology Center
    • Ohio
      • Athens, Ohio, Forenede Stater, 45701
        • Oakview Dermatology
      • Boardman, Ohio, Forenede Stater, 44512
        • Optima Research
      • Fairborn, Ohio, Forenede Stater, 45324
        • Dermatologists of Central States LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73170
        • Central Sooner Research
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Oregon Dermatology and Research Center
      • Portland, Oregon, Forenede Stater, 97201
        • Oregon Medical Research Center
    • Pennsylvania
      • Exton, Pennsylvania, Forenede Stater, 19341
        • The Pennsylvania Centre for Dermatology, LLC
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57702
        • Health Concepts
    • Texas
      • Arlington, Texas, Forenede Stater, 76011
        • Arlington Research Center, Inc.
      • Bellaire, Texas, Forenede Stater, 77401
        • The University of Texas Health Science Center at Houston
      • Houston, Texas, Forenede Stater, 77004
        • Center for Clinical Studies 1
      • San Antonio, Texas, Forenede Stater, 78218
        • Texas Dermatology and Laser Specialists
      • Webster, Texas, Forenede Stater, 77598
        • Center For Clinical Studies
    • Utah
      • Springville, Utah, Forenede Stater, 84663
        • Springville Dermatology CCT Research
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23502
        • Virginia Dermatology Skin Cancer Center Pllc
    • Washington
      • Mill Creek, Washington, Forenede Stater, 98012
        • Frontier Derm Partners CRO, LLC
      • Spokane, Washington, Forenede Stater, 99202
        • Premier Clinical Research
  • Frankrig
      • Antony, Frankrig, 92160
        • Hôpital Privé d'Antony
      • Argenteuil, Frankrig, 95107
        • Centre Hospitalier Victor Dupouy
  • Italien
      • Palermo, Italien, 90127
        • Azienda Di Rilievo Nazionale E Di Alta Specializzazione
      • Parma, Italien, 43126
        • Azienda Ospedaliero Universitaria di Parma
      • Roma, Italien, 00133
        • Policlinico Tor Vergata
      • Rozzano, Italien, 20089
        • Istituto Clinico Humanitas
  • Japan
      • Itabashi Ku, Japan, 173 8606
        • Teikyo University Hospital
      • Kitakyushu-shi, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health
      • Mito, Japan, 310 0015
        • Mito Kyodo General Hospital
      • Nagoya, Japan, 467 8602
        • Nagoya City University Hospital
      • Osaka Sayama Shi, Japan, 589 8511
        • Kindai University Hospital
      • Sendai, Japan, 980 8574
        • Tohoku University Hospital
      • Shinjuku, Japan, 160 0023
        • Tokyo Medical University Hospital
      • Tsu, Japan, 514 8507
        • Mie University Hospital
  • Kina
      • Beijing, Kina, 100191
        • Peking University Third Hospital
      • Beijing, Kina, 100050
        • Beijing Friendship Hospital Capital Medical University
      • Beijing, Kina, 100013
        • China Japan Friendship Hospital
      • Bengbu, Kina, 233099
        • The Affiliated Hospital of Bengbu Medical College
      • Chengde, Kina, 067030
        • Hosp. of Chengde Medical University
      • Chengdu, Kina, 610017
        • Chengdu Second People's Hospital
      • Jiaxing, Kina, 314001
        • The First Hospital of Jiaxing
      • Jinan, Kina, 250012
        • Qilu Hospital of Shandong University
      • Nanchang, Kina, 330000
        • Dermatology Hospital of Jiangxi Province
      • Nanyang, Kina, 473004
        • Nanyang First People's Hospital
      • Shanghai, Kina, 200443
        • Shanghai Skin Disease Hospital
      • Shenyang, Kina, 110016
        • Northeast International Hospital
      • Wuhan, Kina, 430022
        • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
      • Xi'an, Kina, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Zhenjiang, Kina, 212001
        • Affiliated Hospital of Jiangsu University
  • Polen
      • Bialystok, Polen, 15-351
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok, Polen, 15-375
        • Specderm Poznanska sp j
      • Elblag, Polen, 82 300
        • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
      • 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, 90-338
        • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
      • 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, 51 503
        • DERMMEDICA Sp.z o.o.
      • Wroclaw, Polen, 52 416
        • Centrum Medyczne Oporow
      • Wroclaw, Polen, 51 685
        • Wro Medica
  • Spanien
      • Alcorcón, Spanien, 28922
        • Hosp. Univ. Fundacion Alcorcon
      • Alicante, Spanien, 03010
        • Hosp. Gral. Univ. Dr. Balmis
      • Barcelona, Spanien, 08041
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona, Spanien, 08036
        • Hosp Clinic de Barcelona
      • Bilbao, Spanien, 48013
        • Hosp. Univ. de Basurto
      • Madrid, Spanien, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Spanien, 28002
        • Grupo Dermatologico Y Estetico Pedro Jaen
      • Palma de Mallorca, Spanien, 07120
        • Hosp. Univ. Son Espases
      • Santiago de Compostela, Spanien, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Spanien, 41009
        • Hosp. Virgen Macarena
      • Valencia, Spanien, 46940
        • Hosp. de Manises
  • Sydkorea
      • Ansan-si, Sydkorea, 15355
        • Korea University Ansan Hospital
      • Gwangju, Sydkorea, 61453
        • Chosun university hospital
      • Gyeonggi-do, Sydkorea, 13496
        • CHA Bundang Medical Center, CHA University
      • Gyeonggi-do, Sydkorea, 14068
        • Hallym University Sacred Heart Hospital
      • Seoul, Sydkorea, 05505
        • Asan Medical Center
  • Taiwan
      • Hsinchu, Taiwan, 30059
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 33382
        • Linkou Chang Gung Memorial Hospital
  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye), 06560
        • Gazi University Medical Faculty
      • Ankara, Tyrkiet (Türkiye), 06230
        • Hacettepe University Medical Faculty
      • Kayseri, Tyrkiet (Türkiye), 38039
        • Erciyes University Medical Faculty
      • Samsun, Tyrkiet (Türkiye), 55270
        • Ondokuz Mayis University
  • Tyskland
      • Bad Bentheim, Tyskland, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Tyskland, 10117
        • Charite - Campus Mitte
      • Bonn, Tyskland, 53127
        • Universitätsklinikum Bonn
      • Dresden, Tyskland, 01069
        • Klinische Forschung Dresden GmbH
      • Dülmen, Tyskland, 48249
        • Hautzentrum Dulmen
      • Düsseldorf, Tyskland, 40212
        • Privatpraxis Dr. Hilton & Partner
      • Frankfurt am Main, Tyskland, 60590
        • Universitaetsklinikum Frankfurt
      • Freiburg im Breisgau, Tyskland, 79104
        • Universitaetsklinikum Freiburg
      • Friedrichshafen, Tyskland, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Heidelberg, Tyskland, 69120
        • UniversitaetsKlinikum Heidelberg
      • Mahlow, Tyskland, 15831
        • Hautarztpraxis
      • Münster, Tyskland, 48149
        • Universitaetsklinikum Muenster
      • Oldenburg, Tyskland, 26133
        • Klinikum Oldenburg
      • Remscheid, Tyskland, 42897
        • Hautarztpraxis Mortazawi
      • Tübingen, Tyskland, 72076
        • Universitaetsklinik Tuebingen
      • Witten, Tyskland, 58453
        • Hautarztpraxis 2
      • Wuppertal, Tyskland, 42287
        • CentroDerm GmbH
  • Ungarn
      • Borgyogyaszati Klinika, Ungarn, 7632
        • Pecsi Tudomanyegyetem
      • Budapest, Ungarn, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Debrecen, Ungarn, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Ungarn, 4031
        • Derma-B Kft
      • Kaposvár, Ungarn, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
      • 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.

Deltagelseskriterier

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

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Diagnose af plaque psoriasis, med eller uden psoriasisgigt, i mindst 26 uger før den første administration af undersøgelsesintervention
  • Total kropsoverfladeareal (BSA) større end eller lig med (>=)10 procent (%) ved screening og baseline
  • Total psoriasisareal og sværhedsgradsindeks (PASI) >=12 ved screening og baseline
  • Total investigator global assessment (IGA) >=3 ved screening og baseline
  • Kandidat til fototerapi eller systemisk behandling af plaque psoriasis
  • En kvindelig deltager i den fødedygtige alder skal have en negativ højsensitiv serumgraviditetstest beta-humant choriongonadotropin (beta-hCG) ved screening og en negativ uringraviditetstest i uge 0 før administration af undersøgelsesintervention

Ekskluderingskriterier:

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

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: JNJ-77242113
Unge og voksne deltagere vil modtage JNJ-77242113 fra uge 0 til og med uge 156. I uge 24 scorede voksne deltagere, der er psoriasis area and severity index (PASI) 75 eller investigator global assessment (IGA) på 0 eller 1 respondere (det vil sige dem, der opnår en IGA-score på 0 eller 1 og har >=2- grad forbedring fra baseline) vil blive re-randomiseret enten for at fortsætte JNJ-77242113 eller til placebo (og vil blive behandlet igen med JNJ-77242113 ved tab af >=50 % af deres Uge 24 PASI forbedring). Voksne deltagere, der er identificeret som både PASI 75 og IGA 0 eller 1 score ikke-respondere, vil fortsætte med at modtage JNJ-77242113 til og med uge 52. Fra uge 52 til uge 156 vil alle voksne deltagere modtage JNJ-77242113. Unge deltager ikke i re-randomisering uanset deres PASI-score eller IGA-score i uge 24. Unge vil fortsat modtage JNJ-77242113 fra uge 0 til og med uge 156.
Medicin: JNJ-77242113
JNJ-77242113 vil blive indgivet oralt.
Eksperimentel: Placebo
Unge og voksne deltagere vil modtage JNJ-77242113 matchende placebo fra uge 0 til uge 16. Deltagerne vil krydse for at modtage JNJ-77242113 fra uge 16 til og med uge 156.
Medicin: Placebo
Placebo vil blive indgivet oralt
Medicin: JNJ-77242113
JNJ-77242113 vil blive indgivet oralt.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
Tidsramme: Week 16
IGA assesses participant's plaque psoriasis.Lesions were graded for induration,erythema and scaling, each using 5 point scale.Induration: 0=no evidence of plaque elevation,1=minimal plaque elevation,=0.25 millimeters(mm);2=mild plaque elevation,=0.5mm;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; occasional fine scale over <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 a 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
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Tidsramme: Week 16
Percentage of participants who achieved PASI 90 (at least 90% improvement from baseline in PASI score) response at Week 16 were 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline i PASI total score i uge 16
Tidsramme: Baseline (uge 0), uge 16
Ændringen fra baseline i den samlede PASI-score i uge 16 blev rapporteret. PASI var et system, der blev brugt til at vurdere og graduere sværhedsgraden af psoriatiske læsioner og deres respons på behandling. I PASI-systemet blev kroppen opdelt i 4 regioner: hovedet, overkroppen, overekstremiteterne og underekstremiteterne. Hver af disse områder blev vurderet og scoreret separat for erytem, induration og skældannelse, som hver blev vurderet på en skala fra 0 til 4 (0=ingen, 1=svag, 2=moderat, 3=svær og 4=meget svær) og omfanget af involvering fra 0 (angav ingen involvering) til 6 (90% - 100% involvering). PASI producerede en numerisk totalscore, der kunne variere fra 0 (ingen psoriasis) til 72 (maksimal psoriasis). Højere score indikerede større sværhedsgrad af psoriasis. Baseline blev defineret som den tætteste måling taget før eller på tidspunktet for den første administrationsdato af undersøgelsesmedicinen.
Baseline (uge 0), uge 16
Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Tidsramme: Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeter (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 Week 4
Tidsramme: Week 4
Percentage of participants who achieved PASI 75 (at least >=75% improvement from baseline in PASI) response at Week 4 were 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 4
Percentage of Participants Who Achieved PASI 90 Response at Week 8
Tidsramme: Week 8
Percentage of participants who achieved PASI 90 (at least >=90% improvement from baseline in PASI) response at Week 8 were 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 PASI 75 Response at Week 16
Tidsramme: Week 16
Percentage of participants who achieved PASI 75 (>=75% improvement from baseline in PASI) response at Week 16 were 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 100 Response at Week 16
Tidsramme: Week 16
Percentage of participants who achieved PASI 100 (100% improvement from baseline in PASI) response at Week 16 were 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 Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2
Tidsramme: Week 16
The ss-IGA instrument is 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 are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. Higher score indicated 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 Week 8 Among Participants With a Baseline PSSD Symptom Score >0
Tidsramme: 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 first 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
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
Tidsramme: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived first 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 4 Among Participants With a Baseline PSSD Itch Score >=4
Tidsramme: 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 >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a Baseline PSSD Itch Score >=4
Tidsramme: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was 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 PASI 75 Response at Week 52 Among Participants Randomized at Week 24 and Were PASI 75 Responders at Week 24
Tidsramme: Week 52
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Week 52 among participants randomized at Week 24 and were PASI 75 responders at Week 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. Baseline=closest measurement taken prior to or at time of first study drug administration date.
Week 52
Percentage of Participants Who Achieved PASI 90 Response at Week 52 Among Participants Randomized at Week 24 and Were PASI 90 Responders at Week 24
Tidsramme: Week 52
Percentage of participants who achieved PASI 90 (at least >=90% improvement from baseline in PASI) response at Week 52 among participants randomized at Week 24 and were PASI 90 responders at Week 24 were reported. 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. Baseline=closest measurement taken prior to or at time of first study drug administration date.
Week 52
Time to Loss of PASI 75 Among Participants Randomized at Week 24 and Were PASI 75 Responders at Week 24
Tidsramme: Week 24 up to Week 52
Time to loss of PASI 75 response was defined as time from re-randomization at Week 24 to visit of loss of PASI 75 response. Loss of PASI 75 response was defined as less than (<)75% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=75% improvement in PASI from baseline at Week 24. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: 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). PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.
Week 24 up to Week 52
Time to Loss of PASI 90 Among Participants Randomized at Week 24 and Were PASI 90 Responders at Week 24
Tidsramme: Week 24 up to Week 52
The time to loss of PASI 90 response was defined as the time from re-randomization at Week 24 to the visit of loss of PASI 90 response. Loss of PASI 90 response is defined as <90% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=90% improvement in PASI from baseline at Week 24. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: 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). PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.
Week 24 up to Week 52
Change From Baseline in Body Surface Area (BSA) at Week 16
Tidsramme: Baseline (Week 0), Week 16
A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percent Change From Baseline in PASI Total Score at Week 16
Tidsramme: Baseline (Week 0), Week 16
Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-Grade Improvement in Genital Psoriasis From Baseline at Week 16 Among Participants With a Baseline sPGA-G Score >=2
Tidsramme: Week 16
Percentage of participants achieving a sPGA-G Score of 0 or 1 and at least a 2-grade improvement in genital psoriasis from baseline at Week 16 among participants with a baseline sPGA-G score >=2 was reported. 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 Achieving a Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and at Least a 2-grade Improvement at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
Tidsramme: Week 16
Percentage of participants achieving a hf-PGA score of 0 or 1 and at least a 2-grade improvement at Week 16 among participants with a baseline hf-PGA score >=2 was reported. 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 Baseline mNAPSI Score >0
Tidsramme: Baseline (Week 0), Week 16
The mNAPSI was an index used for assessing and grading the severity of nail psoriasis. Each of the participant's ten fingernails are evaluated on 7 features. The first three features are each scored from 0 to 3 in severity and were 1 = onycholysis and oil-drop dyschromia, 2 = pitting, and 3 = nail plate crumbling. The 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 the lunula. Each fingernail is rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). The total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). The higher the score the more severe the nail bed 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 Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With a Baseline f-PGA Score >=2
Tidsramme: Week 16
Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4= severe. 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
Change From Baseline in PSSD Symptom Score at Week 16
Tidsramme: Baseline (Week 0), 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.
Baseline (Week 0), Week 16
Change From Baseline in PSSD Sign Score at Week 16
Tidsramme: Baseline (Week 0), 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.
Baseline (Week 0), Week 16
Percentage of Participants Achieving PSSD Sign Score of 0 at Week 16 Among Participants With Baseline PSSD Sign Score >0
Tidsramme: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With Baseline GenPS-SFQ Item 2 Score >=2 and a Baseline sPGA-G Score >=3
Tidsramme: Week 16
Percentage of participants achieving GenPs-SFQ Item 2 score of 0 or 1 at Week 16 among participants with baseline GenPS-SFQ Item 2 score >=2 and a baseline sPGA-G score >=3 was reported. 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 Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1
Tidsramme: Week 16
The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in Total DLQI Score at Week 16
Tidsramme: Baseline (Week 0), Week 16
Change from baseline in total DLQI score at Week 16 was reported. 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.
Baseline (Week 0), Week 16
Adult Participants: Change From Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
Tidsramme: Baseline (Week 0), Week 16
PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T score=more of concept being measured that is, higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles=better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date.
Baseline (Week 0), Week 16
Adolescent Participants: Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score >1
Tidsramme: 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
Adolescent Participants: Change From Baseline in CDLQI at Week 16
Tidsramme: Baseline (Week 0), 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.
Baseline (Week 0), Week 16
Adolescent Participants: Change From Baseline in Domain Scores of the PROMIS-25 Pediatric Score at Week 16
Tidsramme: 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
Percentage of Participants Who Achieved an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 52
Tidsramme: Week 52
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, =0.25mm; 2=mild plaque elevation, =0.5 mm; 3=moderate plaque elevation, =0.75mm;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 a 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 52
Percentage of Participants Achieving IGA Score of 0 at Week 52 Among Participants Who Were IGA 0 Responders at Week 24
Tidsramme: Week 52
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 52
Percentage of Participants Achieving PASI 100 Response at Week 52 Among PASI 100 Responders at Week 24
Tidsramme: Week 52
Percentage of participants achieving PASI 100 (100% improvement from baseline in PASI) response at Week 52 among PASI 100 responders at Week 24 were 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.
Week 52
Time to Loss of IGA Response of 0 or 1
Tidsramme: Week 24 up to Week 52
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 24 up to Week 52
Adolescent Participants: Percentage of Participants With IGA Score of 0 or 1 and a >=2-grade Improvement From Baseline at Week 52
Tidsramme: Week 52
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, >1mm; 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 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). Higher score=more severe disease. Baseline:closest measurement taken prior to or at time of first study drug administration date.
Week 52
Adolescent Participants: Percentage of Participants Who Achieved PASI 75 Response at Week 52
Tidsramme: Week 52
Percentage of participants who achieved PASI 75 (>=75% improvement in PASI from baseline) response at Week 52 were 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. Baseline:closest measurement taken prior to or at time of first study drug administration date.
Week 52
Adolescent Participants: Percentage of Participants Who Achieved PASI 90 Response at Week 52
Tidsramme: Week 52
Percentage of participants who achieved PASI 90 (at least >=90% improvement in PASI from baseline) response at Week 52 were 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. Baseline: closest measurement taken prior to or at time of first study drug administration date.
Week 52
Number of Participants With Treatment-emergent Adverse Events (AEs)
Tidsramme: From Week 0 up to Week 160
From Week 0 up to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Tidsramme: From Week 0 up to Week 160
From Week 0 up to Week 160

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Efterforskere

  • Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publikationer og nyttige links

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

Generelle publikationer

Datoer for undersøgelser

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

Studer store datoer

Studiestart (Faktiske)

12. oktober 2023

Primær færdiggørelse (Faktiske)

29. juli 2024

Studieafslutning (Anslået)

6. april 2027

Datoer for studieregistrering

Først indsendt

18. oktober 2023

Først indsendt, der opfyldte QC-kriterier

18. oktober 2023

Først opslået (Faktiske)

23. oktober 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 77242113PSO3001 (Anden identifikator: Janssen Research & Development, LLC)
  • 2023-505120-59-00 (Registry Identifier: EUCT number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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