Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Studie JNJ-77242113 u dospívajících a dospělých účastníků se středně těžkou až těžkou plakovou psoriázou (ICONIC-LEAD)

4. června 2026 aktualizováno: Janssen Research & Development, LLC

Multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie fáze 3 k vyhodnocení účinnosti a bezpečnosti JNJ-77242113 pro léčbu účastníků se středně těžkou až těžkou plakovou psoriázou s náhodným stažením a opakovanou léčbou

Účelem této studie je zjistit, jak účinný je JNJ-77242113 u účastníků se středně těžkou až těžkou plakovou psoriázou.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

684

Fáze

  • Fáze 3

Kontakty a umístění

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

Studijní místa

  • 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
  • Austrálie
      • East Melbourne, Austrálie, 3002
        • Dr Rodney Sinclair Pty Ltd
      • Melbourne, Austrálie, 3004
        • The Alfred Hospital
      • Miranda, Austrálie, 2228
        • Kingsway Dermatology & Aesthetics
      • Mitcham, Austrálie, 3132
        • ISHI dermatology
      • Parkville, Austrálie, 3050
        • Royal Melbourne Hospital
      • Woolloongabba, Austrálie, 4102
        • Veracity Clinical Research
  • Francie
      • Antony, Francie, 92160
        • Hôpital Privé d'Antony
      • Argenteuil, Francie, 95107
        • Centre Hospitalier Victor Dupouy
  • Itálie
      • Palermo, Itálie, 90127
        • Azienda Di Rilievo Nazionale E Di Alta Specializzazione
      • Parma, Itálie, 43126
        • Azienda Ospedaliero Universitaria di Parma
      • Roma, Itálie, 00133
        • Policlinico Tor Vergata
      • Rozzano, Itálie, 20089
        • Istituto Clinico Humanitas
  • Japonsko
      • Itabashi Ku, Japonsko, 173 8606
        • Teikyo University Hospital
      • Kitakyushu-shi, Japonsko, 807-8556
        • Hospital of the University of Occupational and Environmental Health
      • Mito, Japonsko, 310 0015
        • Mito Kyodo General Hospital
      • Nagoya, Japonsko, 467 8602
        • Nagoya City University Hospital
      • Osaka Sayama Shi, Japonsko, 589 8511
        • Kindai University Hospital
      • Sendai, Japonsko, 980 8574
        • Tohoku University Hospital
      • Shinjuku, Japonsko, 160 0023
        • Tokyo Medical University Hospital
      • Tsu, Japonsko, 514 8507
        • Mie University Hospital
  • Jižní Korea
      • Ansan-si, Jižní Korea, 15355
        • Korea University Ansan Hospital
      • Gwangju, Jižní Korea, 61453
        • Chosun university hospital
      • Gyeonggi-do, Jižní Korea, 13496
        • CHA Bundang Medical Center, CHA University
      • Gyeonggi-do, Jižní Korea, 14068
        • Hallym University Sacred Heart Hospital
      • Seoul, Jižní Korea, 05505
        • Asan Medical Center
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2J 7E1
        • Dermatology Research Institute Inc
      • Edmonton, Alberta, Kanada, T5J 3S9
        • Rejuvenation Dermatology Clinic Edmonton Downtown
    • British Columbia
      • Surrey, British Columbia, Kanada, V3R 6A7
        • Dr. Chih ho Hong Medical
    • Ontario
      • London, Ontario, Kanada, N6H 5L5
        • Dr Wei Jing Loo Medicine Professional Corporation
      • London, Ontario, Kanada, N5X 2P1
        • Mediprobe Research Inc.
      • Newmarket, Ontario, Kanada, L3Y 5G8
        • Ryan Clinical Research Inc
      • Toronto, Ontario, Kanada, M3H 5Y8
        • Toronto Research Centre
      • Toronto, Ontario, Kanada, M3B 0A7
        • Canadian Dermatology Center
      • Toronto, Ontario, Kanada, M4C 1L1
        • Facet Dermatology
      • Windsor, Ontario, Kanada, N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, Kanada, H2X 2V1
        • Innovaderm Research Inc.
  • Maďarsko
      • Borgyogyaszati Klinika, Maďarsko, 7632
        • Pecsi Tudomanyegyetem
      • Budapest, Maďarsko, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Debrecen, Maďarsko, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Maďarsko, 4031
        • Derma-B Kft
      • Kaposvár, Maďarsko, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
      • Szeged, Maďarsko, 6720
        • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
      • Szolnok, Maďarsko, 5000
        • Allergo-Derm Bakos Kft.
      • Veszprém, Maďarsko, 8200
        • Medmare Egeszsegugyi Es Szolgaltato Bt.
  • Německo
      • Bad Bentheim, Německo, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Německo, 10117
        • Charite - Campus Mitte
      • Bonn, Německo, 53127
        • Universitätsklinikum Bonn
      • Dresden, Německo, 01069
        • Klinische Forschung Dresden GmbH
      • Dülmen, Německo, 48249
        • Hautzentrum Dulmen
      • Düsseldorf, Německo, 40212
        • Privatpraxis Dr. Hilton & Partner
      • Frankfurt am Main, Německo, 60590
        • Universitaetsklinikum Frankfurt
      • Freiburg im Breisgau, Německo, 79104
        • Universitaetsklinikum Freiburg
      • Friedrichshafen, Německo, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Heidelberg, Německo, 69120
        • UniversitaetsKlinikum Heidelberg
      • Mahlow, Německo, 15831
        • Hautarztpraxis
      • Münster, Německo, 48149
        • Universitaetsklinikum Muenster
      • Oldenburg, Německo, 26133
        • Klinikum Oldenburg
      • Remscheid, Německo, 42897
        • Hautarztpraxis Mortazawi
      • Tübingen, Německo, 72076
        • Universitaetsklinik Tuebingen
      • Witten, Německo, 58453
        • Hautarztpraxis 2
      • Wuppertal, Německo, 42287
        • CentroDerm GmbH
  • Polsko
      • Bialystok, Polsko, 15-351
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok, Polsko, 15-375
        • Specderm Poznanska sp j
      • Elblag, Polsko, 82 300
        • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
      • Krakow, Polsko, 31-411
        • Centrum Medyczne Promed
      • Krakow, Polsko, 30 438
        • Centrum Medyczne dr Rajzer Sp z o o
      • Krakow, Polsko, 30-002
        • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
      • Lodz, Polsko, 90-338
        • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
      • Lodz, Polsko, 90-265
        • Dermed Centrum Medyczne Sp z o o
      • Osielsko, Polsko, 86031
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
      • Poznan, Polsko, 61 731
        • Clinical Research Center sp z o o MEDIC R s k
      • Poznan, Polsko, 60 529
        • Solumed Centrum Medyczne
      • Warsaw, Polsko, 02 953
        • Klinika Ambroziak Dermatologia
      • Warsaw, Polsko, 01 817
        • Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
      • Wroclaw, Polsko, 51 503
        • DERMMEDICA Sp.z o.o.
      • Wroclaw, Polsko, 52 416
        • Centrum Medyczne Oporow
      • Wroclaw, Polsko, 51 685
        • Wro Medica
  • Spojené království
      • Harrow, Spojené království, HA1 3UJ
        • London North West University Healthcare NHS Trust
      • London, Spojené království, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Reading, Spojené království, RG1 5AN
        • Royal Berkshire Hospital
      • Salford, Spojené království, M6 8HD
        • Salford Royal Hospital
  • Spojené státy
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85006
        • Medical Dermatology Specialists
    • Arkansas
      • Fort Smith, Arkansas, Spojené státy, 72916
        • Johnson Dermatology
    • California
      • Fountain Valley, California, Spojené státy, 92708
        • First OC Dermatology
      • Fremont, California, Spojené státy, 94538
        • Center for Dermatology Clinical Research
      • Sacramento, California, Spojené státy, 95815
        • Integrative Skin Science and Research
      • San Diego, California, Spojené státy, 92123
        • Rady Childrens Hospital San Diego
      • Santa Ana, California, Spojené státy, 92701
        • Southern California Dermatology
      • Santa Monica, California, Spojené státy, 90403
        • Clinical Science Institute
    • Florida
      • Miami, Florida, Spojené státy, 33155
        • Bioclinical Research Alliance Inc.
      • North Miami Beach, Florida, Spojené státy, 33162
        • Ziaderm Research LLC
      • Tampa, Florida, Spojené státy, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Macon, Georgia, Spojené státy, 31217
        • Skin Care Physicians of Georgia
    • Illinois
      • Rolling Meadows, Illinois, Spojené státy, 60008
        • Arlington Dermatology
      • Skokie, Illinois, Spojené státy, 60077
        • Endeavor Health
      • West Dundee, Illinois, Spojené státy, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, Spojené státy, 46250
        • Dawes Fretzin Clinical Research Group LLC
      • Plainfield, Indiana, Spojené státy, 46168
        • Indiana Clinical Trial Center
    • Kentucky
      • Owensboro, Kentucky, Spojené státy, 42301
        • Qualmedica Research
    • Louisiana
      • Lake Charles, Louisiana, Spojené státy, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Beverly, Massachusetts, Spojené státy, 01915
        • Allcutis Research 1
    • Michigan
      • Clarkston, Michigan, Spojené státy, 48346
        • Michigan Center of Medical Research
    • Minnesota
      • New Brighton, Minnesota, Spojené státy, 55112
        • Minnesota Clinical Study Center
    • Nebraska
      • Omaha, Nebraska, Spojené státy, 68144
        • Skin Specialists
    • New Hampshire
      • Portsmouth, New Hampshire, Spojené státy, 03801
        • Allcutis Research
    • New Jersey
      • East Windsor, New Jersey, Spojené státy, 08520
        • Schweiger Dermatology Group
    • New York
      • New York, New York, Spojené státy, 10029
        • Icahn School of Medicine at Mt. Sinai
    • North Carolina
      • Wilmington, North Carolina, Spojené státy, 28405
        • Wilmington Dermatology Center
    • Ohio
      • Athens, Ohio, Spojené státy, 45701
        • Oakview Dermatology
      • Boardman, Ohio, Spojené státy, 44512
        • Optima Research
      • Fairborn, Ohio, Spojené státy, 45324
        • Dermatologists of Central States LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, Spojené státy, 73170
        • Central Sooner Research
    • Oregon
      • Portland, Oregon, Spojené státy, 97210
        • Oregon Dermatology and Research Center
      • Portland, Oregon, Spojené státy, 97201
        • Oregon Medical Research Center
    • Pennsylvania
      • Exton, Pennsylvania, Spojené státy, 19341
        • The Pennsylvania Centre for Dermatology, LLC
      • Pittsburgh, Pennsylvania, Spojené státy, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, Spojené státy, 29425
        • Medical University of South Carolina
    • South Dakota
      • Rapid City, South Dakota, Spojené státy, 57702
        • Health Concepts
    • Texas
      • Arlington, Texas, Spojené státy, 76011
        • Arlington Research Center, Inc.
      • Bellaire, Texas, Spojené státy, 77401
        • The University of Texas Health Science Center at Houston
      • Houston, Texas, Spojené státy, 77004
        • Center for Clinical Studies 1
      • San Antonio, Texas, Spojené státy, 78218
        • Texas Dermatology and Laser Specialists
      • Webster, Texas, Spojené státy, 77598
        • Center For Clinical Studies
    • Utah
      • Springville, Utah, Spojené státy, 84663
        • Springville Dermatology CCT Research
    • Virginia
      • Norfolk, Virginia, Spojené státy, 23502
        • Virginia Dermatology Skin Cancer Center Pllc
    • Washington
      • Mill Creek, Washington, Spojené státy, 98012
        • Frontier Derm Partners CRO, LLC
      • Spokane, Washington, Spojené státy, 99202
        • Premier Clinical Research
  • Tchaj-wan
      • Hsinchu, Tchaj-wan, 30059
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City, Tchaj-wan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Tchaj-wan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Tchaj-wan, 10449
        • Mackay Memorial Hospital
      • Taipei, Tchaj-wan, 10048
        • National Taiwan University Hospital
      • Taoyuan, Tchaj-wan, 33382
        • Linkou Chang Gung Memorial Hospital
  • Turecko (Türkiye)
      • Ankara, Turecko (Türkiye), 06560
        • Gazi University Medical Faculty
      • Ankara, Turecko (Türkiye), 06230
        • Hacettepe University Medical Faculty
      • Kayseri, Turecko (Türkiye), 38039
        • Erciyes University Medical Faculty
      • Samsun, Turecko (Türkiye), 55270
        • Ondokuz Mayis University
  • Čína
      • Beijing, Čína, 100191
        • Peking University Third Hospital
      • Beijing, Čína, 100050
        • Beijing Friendship Hospital Capital Medical University
      • Beijing, Čína, 100013
        • China Japan Friendship Hospital
      • Bengbu, Čína, 233099
        • The Affiliated Hospital of Bengbu Medical College
      • Chengde, Čína, 067030
        • Hosp. of Chengde Medical University
      • Chengdu, Čína, 610017
        • Chengdu Second People's Hospital
      • Jiaxing, Čína, 314001
        • The First Hospital of Jiaxing
      • Jinan, Čína, 250012
        • Qilu Hospital of Shandong University
      • Nanchang, Čína, 330000
        • Dermatology Hospital of Jiangxi Province
      • Nanyang, Čína, 473004
        • Nanyang First People's Hospital
      • Shanghai, Čína, 200443
        • Shanghai Skin Disease Hospital
      • Shenyang, Čína, 110016
        • Northeast International Hospital
      • Wuhan, Čína, 430022
        • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
      • Xi'an, Čína, 710004
        • The second Affiliated Hospital of Xi'an Jiaotong University
      • Zhenjiang, Čína, 212001
        • Affiliated Hospital of Jiangsu University
  • Španělsko
      • Alcorcón, Španělsko, 28922
        • Hosp. Univ. Fundacion Alcorcon
      • Alicante, Španělsko, 03010
        • Hosp. Gral. Univ. Dr. Balmis
      • Barcelona, Španělsko, 08041
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona, Španělsko, 08036
        • Hosp Clinic de Barcelona
      • Bilbao, Španělsko, 48013
        • Hosp. Univ. de Basurto
      • Madrid, Španělsko, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Španělsko, 28002
        • Grupo Dermatologico Y Estetico Pedro Jaen
      • Palma de Mallorca, Španělsko, 07120
        • Hosp. Univ. Son Espases
      • Santiago de Compostela, Španělsko, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Španělsko, 41009
        • Hosp. Virgen Macarena
      • Valencia, Španělsko, 46940
        • Hosp. de Manises

Kritéria účasti

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

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

  • Diagnostika plakové psoriázy, s psoriatickou artritidou nebo bez ní, po dobu alespoň 26 týdnů před prvním podáním studijní intervence
  • Celková plocha povrchu těla (BSA) větší nebo rovna (>=)10 procentům (%) při screeningu a výchozí hodnotě
  • Celková plocha psoriázy a index závažnosti (PASI) >=12 při screeningu a výchozí hodnotě
  • Celkové globální hodnocení zkoušejícího (IGA) >=3 při screeningu a výchozí hodnotě
  • Kandidát na fototerapii nebo systémovou léčbu ložiskové psoriázy
  • Účastnice ve fertilním věku musí mít negativní vysoce citlivý sérový těhotenský test na beta-lidský choriový gonadotropin (beta-hCG) při screeningu a negativní těhotenský test z moči v týdnu 0 před zahájením studijní intervence

Kritéria vyloučení:

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

Studijní plán

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

Jak je studie koncipována?

Detaily designu

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

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: JNJ-77242113
Dospívající a dospělí účastníci obdrží JNJ-77242113 od týdne 0 do týdne 156. V týdnu 24 dospělí účastníci, kteří mají psoriázovou oblast a index závažnosti (PASI) 75 nebo zkoušející globální hodnocení (IGA), skóre 0 nebo 1 respondentů (tj. těch, kteří dosáhli skóre IGA 0 nebo 1 a mají >=2- stupeň zlepšení od výchozího stavu) budou znovu randomizováni buď k pokračování JNJ-77242113 nebo k placebu (a budou znovu léčeni JNJ-77242113 při ztrátě >=50 % jejich zlepšení PASI ve 24. týdnu). Dospělí účastníci, kteří byli označeni jako PASI 75 a IGA 0 nebo 1, kteří nereagovali, budou nadále dostávat JNJ-77242113 až do 52. týdne. Od týdne 52 do týdne 156 obdrží všichni dospělí účastníci JNJ-77242113. Adolescenti se nebudou podílet na opětovné randomizaci bez ohledu na jejich skóre PASI nebo IGA v týdnu 24. Dospívající budou nadále dostávat JNJ-77242113 od týdne 0 do týdne 156.
Lék: JNJ-77242113
JNJ-77242113 bude podáván orálně.
Experimentální: Placebo
Dospívající a dospělí účastníci dostanou JNJ-77242113 odpovídající placebo od týdne 0 do týdne 16. Účastníci přejdou, aby obdrželi JNJ-77242113 od týdne 16 do týdne 156.
Lék: Placebo
Placebo bude podáváno perorálně
Lék: JNJ-77242113
JNJ-77242113 bude podáván orálně.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
Časové okno: Week 16
IGA assesses participant's plaque psoriasis.Lesions were graded for induration,erythema and scaling, each using 5 point scale.Induration: 0=no evidence of plaque elevation,1=minimal plaque elevation,=0.25 millimeters(mm);2=mild plaque elevation,=0.5mm;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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Změna od výchozí hodnoty v celkovém skóre PASI v týdnu 16
Časové okno: Výchozí hodnota (týden 0), týden 16
Změna oproti výchozí hodnotě v celkovém skóre PASI v týdnu 16 byla hlášena. PASI byl systém používaný pro hodnocení a klasifikaci závažnosti psoriatických lézí a jejich odpovědi na léčbu. V systému PASI bylo tělo rozděleno do 4 oblastí: hlava, trup, horní končetiny a dolní končetiny. Každá z těchto oblastí byla hodnocena a bodována samostatně pro zarudnutí, zatvrdnutí a šupinatění, přičemž každý z těchto příznaků byl hodnocen na stupnici od 0 do 4 (0 = žádný, 1 = mírný, 2 = střední, 3 = těžký a 4 = velmi těžký) a rozsah postižení od 0 (naznačoval žádné postižení) do 6 (90 % - 100 % postižení). PASI vytvořil číselné celkové skóre, které se mohlo pohybovat od 0 (žádná psoriáza) do 72 (maximální psoriáza). Vyšší skóre naznačovalo větší závažnost psoriázy. Výchozí hodnota byla definována jako nejbližší měření provedené před nebo v době data první podání studijního léku.
Výchozí hodnota (týden 0), týden 16
Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Časové okno: Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived 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
Časové okno: 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
Časové okno: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline (Week 0), Week 16
A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percent Change From Baseline in PASI Total Score at Week 16
Časové okno: Baseline (Week 0), Week 16
Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Week 16
Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4= severe. 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
Časové okno: 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
Časové okno: 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
Časové okno: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants 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
Časové okno: 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
Časové okno: Week 16
The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in Total DLQI Score at Week 16
Časové okno: Baseline (Week 0), Week 16
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
Časové okno: Baseline (Week 0), Week 16
PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T score=more of concept being measured that is, higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles=better functioning. Baseline: closest measurement taken prior to/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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: From Week 0 up to Week 160
From Week 0 up to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Časové okno: From Week 0 up to Week 160
From Week 0 up to Week 160

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Janssen Research & Development, LLC

Vyšetřovatelé

  • Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publikace a užitečné odkazy

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

Obecné publikace

Termíny studijních záznamů

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

Hlavní termíny studia

Začátek studia (Aktuální)

12. října 2023

Primární dokončení (Aktuální)

29. července 2024

Dokončení studie (Odhadovaný)

6. dubna 2027

Termíny zápisu do studia

První předloženo

18. října 2023

První předloženo, které splnilo kritéria kontroly kvality

18. října 2023

První zveřejněno (Aktuální)

23. října 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 77242113PSO3001 (Jiný identifikátor: Janssen Research & Development, LLC)
  • 2023-505120-59-00 (Identifikátor registru: EUCT number)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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

Klinické studie na Plaková psoriáza

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Suriname

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit