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Een onderzoek naar JNJ-77242113 voor de behandeling van deelnemers met matige tot ernstige plaque-psoriasis

2 juli 2026 bijgewerkt door: Janssen Research & Development, LLC

Een fase 3 multicenter, gerandomiseerde, dubbelblinde, placebogecontroleerde en deucravacitinib-actieve comparator-gecontroleerde studie om de werkzaamheid en veiligheid van JNJ-77242113 te evalueren voor de behandeling van deelnemers met matige tot ernstige plaque psoriasis

Het doel van het onderzoek is om te zien hoe effectief JNJ-77242113 is bij deelnemers met matige tot ernstige plaque psoriasis vergeleken met placebo en deucravacitinib.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

774

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Argentinië
      • Buenos Aires, Argentinië, B1643CRO
        • Instituto Medico De Alta Complejidad (IMAC)
      • Buenos Aires, Argentinië, C1406AGA
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • CABA, Argentinië, C1425BEA
        • Instituto de Neumonología Y Dermatología
      • Caba, Argentinië, C1199ABD
        • Hospital Italiano de Buenos Aires
      • Caba, Argentinië, C1122AAF
        • Halitus Instituto Medico S.A. - Dermatologia y Estetica
      • La Plata, Argentinië, B1900AXI
        • Hospital Italiano de La Plata
      • Rosario, Argentinië, S2000PBJ
        • Instituto Caici Srl.
      • San Miguel de Tucumán, Argentinië, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
  • Australië
      • Campbelltown, Australië, 5074
        • North Eastern Health Specialists
      • Canberra, Australië, 2606
        • Paratus Clinical Research Woden
      • East Melbourne, Australië, 3002
        • Sinclair Dermatology
      • Melbourne, Australië, 3053
        • Skin Health Institute Inc.
      • Woolloongabba, Australië, 4102
        • Veracity Clinical Research
  • Brazilië
      • Santo André, Brazilië, 09060-870
        • Fundacao do ABC Centro Universitario FMABC
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
        • Karma Clinical Trials Inc.
    • Ontario
      • Ajax, Ontario, Canada, L1S7K8
        • CCA Medical Research Corporation
      • Barrie, Ontario, Canada, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dermatrials Research
      • Richmond Hill, Ontario, Canada, L4B1L1
        • York Dermatology Clinic and Research Centre
      • Waterloo, Ontario, Canada, N2J 1C4
        • Alliance Clinical Trials
      • Windsor, Ontario, Canada, N8T 1E6
        • XLR8 Medical Research
  • Duitsland
      • Berlin, Duitsland, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Bramsche, Duitsland, 49565
        • Hautarztpraxis 3
      • Dresden, Duitsland, 01069
        • Klinische Forschung Dresden GmbH
      • Dresden, Duitsland, 01097
        • Praxis fuer Dermatologie und Venerologie
      • Düsseldorf, Duitsland, 40225
        • Universitaetsklinikum Duesseldorf
      • Hamburg, Duitsland, 22391
        • MensingDerma Research GmbH
      • Hamburg, Duitsland, 20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Kiel, Duitsland, 24105
        • Universitaetsklinikum Schleswig Holstein Campus Kiel
      • Langenau, Duitsland, 89129
        • Studienzentrum Dr Schwarz Germany
      • Leipzig, Duitsland, 04103
        • Universitätsklinikum Leipzig AöR
      • Lübeck, Duitsland, 23562
        • Universitatsklinikum Schleswig Holstein Campus Lubeck
      • Mannheim, Duitsland, 68167
        • Universitaetsklinikum Mannheim
      • München, Duitsland, 80802
        • Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
      • Potsdam, Duitsland, 14467
        • Hautarztpraxis 1
      • Rostock, Duitsland, 18057
        • Universitaetsmedizin Rostock
  • Hongarije
      • Borgyogyaszati Klinika, Hongarije, 7632
        • Pecsi Tudomanyegyetem
      • Budapest, Hongarije, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Debrecen, Hongarije, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Hongarije, 4031
        • Derma-B Kft
      • Kaposvár, Hongarije, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
      • Szeged, Hongarije, 6720
        • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
      • Szolnok, Hongarije, 5000
        • Allergo-Derm Bakos Kft.
      • Veszprém, Hongarije, 8200
        • Medmare Egeszsegugyi Es Szolgaltato Bt.
  • Japan
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Fukutsu, Japan, 811-3217
        • Hino Dermatology Clinic
      • Gifu, Japan, 501-1112
        • Gifu University Hospital
      • Ginowan, Japan, 901 2725
        • University of the Ryukyus hospital
      • Gunma, Japan, 371 8511
        • Gunma University Hospital
      • Hokkaido, Japan, 060-0033
        • JR Sapporo Hospital
      • Hokkaido, Japan, 078 8510
        • Asahikawa Medical University Hospital
      • Isehara, Japan, 259-1193
        • Tokai University Hospital
      • Itabashi Ku, Japan, 173 8606
        • Teikyo University Hospital
      • Kawasaki, Japan, 216 8511
        • St Marianna University Hospital
      • Kitakyushu-shi, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health
      • Nagoya, Japan, 467 8602
        • Nagoya City University Hospital
      • Nishiku, Japan, 593-8324
        • Kume Clinic
      • Obihiro Shi, Japan, 080 0013
        • Takagi Dermatological Clinic
      • Osaka, Japan, 550 0006
        • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
      • Sakai, Japan, 590 0197
        • Kindai University Hospital
      • Sapporo, Japan, 060 0063
        • Sapporo Skin Clinic
      • Sendai, Japan, 980 8574
        • Tohoku University Hospital
      • Suita, Japan, 565 0871
        • The University of Osaka Hospital
      • Tachikawa, Japan, 190 0023
        • Jitaikai Tachikawa dermatology clinic
      • Takaoka Shi, Japan, 933-0871
        • Shirasaki dermatology clinic
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tsu, Japan, 514 8507
        • Mie University Hospital
  • 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
  • Spanje
      • Alicante, Spanje, 03010
        • Hosp. Gral. Univ. Dr. Balmis
      • Barakaldo, Spanje, 48902
        • Hosp. Univ. de Cruces
      • Barcelona, Spanje, 08041
        • Hosp. de La Santa Creu I Sant Pau
      • Granada, Spanje, 18016
        • Hosp. Univ. San Cecilio
      • L'Hospitalet de Llobregat, Spanje, 08907
        • Hosp. Univ. de Bellvitge
      • Madrid, Spanje, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spanje, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Spanje, 28031
        • Hosp. Univ. Infanta Leonor
      • Madrid, Spanje, 28006
        • Hosp. Univ. de La Princesa
      • Madrid, Spanje, 28046
        • Hosp. Univ. de La Paz
      • Madrid, Spanje, 28002
        • Grupo Dermatologico Y Estetico Pedro Jaen
      • Valencia, Spanje, 46026
        • Hosp. Univ. I Politecni La Fe
  • Taiwan
      • Hsinchu, Taiwan, 30059
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City, Taiwan, 833
        • Chang Kung Memorial Hospital
      • New Taipei City, Taiwan, 235
        • Taipei Medical University Shuang Ho Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taipei, Taiwan, 10449
        • Taipei Mackay Memorial Hospital
      • Taoyuan, Taiwan, 33382
        • Linkou Chang Gung Memorial Hospital
  • Verenigd Koninkrijk
      • London, Verenigd Koninkrijk, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Reading, Verenigd Koninkrijk, RG1 5AN
        • Royal Berkshire Hospital
      • Salford, Verenigd Koninkrijk, M6 8HD
        • Salford Royal Hospital
      • Southampton, Verenigd Koninkrijk, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • Verenigde Staten
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85006
        • Medical Dermatology Specialists
      • Scottsdale, Arizona, Verenigde Staten, 85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fort Smith, Arkansas, Verenigde Staten, 72916
        • Johnson Dermatology
    • California
      • Fountain Valley, California, Verenigde Staten, 92708
        • First OC Dermatology
      • Fremont, California, Verenigde Staten, 94538
        • Center for Dermatology Clinical Research
      • Sacramento, California, Verenigde Staten, 95815
        • Integrative Skin Science and Research
      • Santa Ana, California, Verenigde Staten, 92701
        • Southern California Dermatology
      • Santa Monica, California, Verenigde Staten, 90403
        • Clinical Science Institute
    • Florida
      • Miami, Florida, Verenigde Staten, 33126
        • Driven Research LLC
      • North Miami Beach, Florida, Verenigde Staten, 33162
        • Ziaderm Research LLC
      • Ocala, Florida, Verenigde Staten, 34470
        • Renstar Medical Research
      • Tampa, Florida, Verenigde Staten, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Alpharetta, Georgia, Verenigde Staten, 30022
        • Hamilton Research LLC
      • Macon, Georgia, Verenigde Staten, 31217
        • Skin Care Physicians Of Georgia
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60602
        • DeNova Research
      • Rolling Meadows, Illinois, Verenigde Staten, 60008
        • Arlington Dermatology
      • Skokie, Illinois, Verenigde Staten, 60077
        • Endeavor Health
      • West Dundee, Illinois, Verenigde Staten, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46250
        • Dawes Fretzin Clinical Research Group LLC
      • Plainfield, Indiana, Verenigde Staten, 46168
        • Indiana Clinical Trial Center
    • Kentucky
      • Louisville, Kentucky, Verenigde Staten, 40241
        • Dermatology Specialists
    • Louisiana
      • Lake Charles, Louisiana, Verenigde Staten, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48103
        • David Fivenson MD, Dermatology
      • Clarkston, Michigan, Verenigde Staten, 48346
        • Michigan Center of Medical Research
      • Detroit, Michigan, Verenigde Staten, 48202
        • Henry Ford Medical Center
      • Fort Gratiot, Michigan, Verenigde Staten, 48059
        • Hamzavi Dermatology
    • Missouri
      • Saint Joseph, Missouri, Verenigde Staten, 64506
        • MediSearch Clinical Trials
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68144
        • Skin Specialists
    • Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89119
        • Fife Dermatology
    • New Hampshire
      • Portsmouth, New Hampshire, Verenigde Staten, 03801
        • StracSkin
    • New Jersey
      • East Windsor, New Jersey, Verenigde Staten, 08520
        • Schweiger Dermatology Group
      • Hackensack, New Jersey, Verenigde Staten, 07601
        • Schweiger Dermatology Group 1
    • New York
      • Stony Brook, New York, Verenigde Staten, 11790
        • Derm Research Center of New York, Inc.
    • North Carolina
      • Wilmington, North Carolina, Verenigde Staten, 28405
        • Wilmington Dermatology Center
    • Ohio
      • Athens, Ohio, Verenigde Staten, 45701
        • Oakview Dermatology
      • Boardman, Ohio, Verenigde Staten, 44512
        • Optima Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73170
        • Central Sooner Research
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97201
        • Oregon Medical Research Center
    • South Dakota
      • Rapid City, South Dakota, Verenigde Staten, 57702
        • Health Concepts
    • Texas
      • Dallas, Texas, Verenigde Staten, 75231
        • Modern Research Associates
      • Houston, Texas, Verenigde Staten, 77004
        • Center for Clinical Studies 1
      • Houston, Texas, Verenigde Staten, 77056
        • Austin Institute for Clinical Research 1
      • Pflugerville, Texas, Verenigde Staten, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, Verenigde Staten, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, Verenigde Staten, 78213
        • Progressive Clinical Research
      • Webster, Texas, Verenigde Staten, 77598
        • Center for Clinical Studies
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23294
        • National Clinical Research
    • Washington
      • Mill Creek, Washington, Verenigde Staten, 98012
        • Frontier Derm Partners CRO, LLC
      • Spokane, Washington, Verenigde Staten, 99202
        • Premier Clinical Research
  • Zuid -Korea
      • Busan, Zuid -Korea, 49241
        • Pusan National University Hospital
      • Seongnam-si, Zuid -Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Zuid -Korea, 03080
        • Seoul National University Hospital
      • Seoul, Zuid -Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Zuid -Korea, 05030
        • Konkuk University Medical Center
      • Seoul, Zuid -Korea, 04763
        • Hanyang University Medical Center
      • Seoul, Zuid -Korea, 130 050
        • Kyung Hee University Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

  • Diagnose van plaque psoriasis, met of zonder artritis psoriatica (PsA), gedurende ten minste 26 weken voorafgaand aan de eerste toediening van de onderzoeksinterventie
  • Totaal lichaamsoppervlak (BSA) groter dan of gelijk aan (>=)10 procent (%) bij screening en baseline
  • Totaal psoriasisgebied en ernstindex (PASI) >=12 bij screening en baseline
  • Totale globale beoordeling door onderzoeker (IGA) >=3 bij screening en baseline
  • Kandidaat voor fototherapie of systemische behandeling voor plaque psoriasis

Uitsluitingscriteria:

  • Niet-plaque vorm van psoriasis (bijvoorbeeld erytrodermisch, guttaat of pustulair)
  • Huidige door geneesmiddelen geïnduceerde psoriasis (bijvoorbeeld een nieuw begin van psoriasis of een verergering van psoriasis door bètablokkers, calciumantagonisten of lithium)
  • Een huidige diagnose of tekenen of symptomen van ernstige, progressieve of ongecontroleerde nier-, lever-, hart-, vasculaire, long-, gastro-intestinale, endocriene, neurologische, hematologische, reumatologische, psychiatrische of metabolische stoornissen
  • Bekende allergieën, overgevoeligheid of intolerantie voor JNJ-77242113 of de hulpstoffen ervan
  • Grote chirurgische ingreep (waarbij bijvoorbeeld algemene anesthesie nodig is) binnen 8 weken vóór de screening, of niet volledig hersteld is van de chirurgische ingreep, of er is een chirurgische ingreep gepland gedurende de tijd dat de deelnemer naar verwachting aan het onderzoek zal deelnemen

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: JNJ-77242113
Deelnemers ontvangen JNJ-77242113 van week 0 tot en met week 156 en deucravacitinib, een overeenkomende placebo van week 0 tot en met week 24.
Geneesmiddel: JNJ-77242113
JNJ-77242113 zal oraal worden toegediend.
Geneesmiddel: Deucravacitinib Matchend Placebo
Deucravacitinib-matching-placebo zal oraal worden toegediend.
Placebo-vergelijker: Placebo
Deelnemers krijgen van week 0 tot en met week 16 een bijpassende placebo voor JNJ-77242113, een bijpassende placebo voor deucravacitinib van week 0 tot en met week 24 en JNJ-77242113 van week 16 tot en met week 156.
Geneesmiddel: JNJ-77242113
JNJ-77242113 zal oraal worden toegediend.
Geneesmiddel: JNJ-77242113 Overeenkomende placebo
JNJ-77242113 overeenkomende placebo zal oraal worden toegediend.
Geneesmiddel: Deucravacitinib Matchend Placebo
Deucravacitinib-matching-placebo zal oraal worden toegediend.
Actieve vergelijker: Deucravacitinib
Deelnemers krijgen deucravacitinib van week 0 tot en met week 24 en een bijpassende placebo voor JNJ-77242113 van week 0 tot en met week 24 en JNJ-77242113 van week 24 tot en met week 156.
Geneesmiddel: JNJ-77242113
JNJ-77242113 zal oraal worden toegediend.
Geneesmiddel: JNJ-77242113 Overeenkomende placebo
JNJ-77242113 overeenkomende placebo zal oraal worden toegediend.
Geneesmiddel: Deucravacitinib
Deucravacitinib zal oraal worden toegediend.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
Tijdsspanne: Week 16
IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema, scaling, each using 5 point scale. Induration:0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25 millimeters(mm); 2=mild plaque elevation,=0.5 mm; 3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation,>1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe(4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
Tijdsspanne: Week 16
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Body Surface Area (BSA) at Week 16
Tijdsspanne: 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
Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Tijdsspanne: Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Week 16
Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0
Tijdsspanne: Weeks 8 and 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 8 and 16
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16 Among Participants With a Baseline PSSD Itch Score >=4
Tijdsspanne: Weeks 4 and 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.
Weeks 4 and 16
Percentage of Participants Who Achieved an IGA Score of 0 at Weeks 16 and 24
Tijdsspanne: Weeks 16 and 24
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Weeks 16 and 24
Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0
Tijdsspanne: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With a Baseline GenPS-SFQ Item 2 Score >=2 and With a Baseline sPGA-G Score >=3
Tijdsspanne: Week 16
The GenPs-SFQ was a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days. Item 1 assesses overall frequency of sexual activity in the last 7 days (none/zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (0 = never, 1 = rarely, 2 = sometimes, 3 = often, or 4 = always). Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Dermatological Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1
Tijdsspanne: 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
Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1
Tijdsspanne: Weeks 16 and 24
The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 75 at Weeks 4 and 16
Tijdsspanne: Weeks 4 and 16
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 4 and 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 4 and 16
Percentage of Participants Who Achieved PASI 90 at Week 8
Tijdsspanne: Week 8
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 8 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 8
Percentage of Participants Who Achieved PASI 100 at Week 16
Tijdsspanne: Week 16
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved a 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
Tijdsspanne: Week 16
The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Weeks 16 and 24
Tijdsspanne: Weeks 16 and 24
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 <5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 75 at Weeks 16 and 24
Tijdsspanne: Weeks 16 and 24
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 90 at Weeks 16 and 24
Tijdsspanne: Weeks 16 and 24
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 100 at Weeks 16 and 24
Tijdsspanne: Weeks 16 and 24
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With a Baseline Symptom Score >0
Tijdsspanne: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date
Week 16
Change From Baseline in PASI Total Score at Week 16
Tijdsspanne: Baseline (Week 0), Week 16
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 was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percent Change From Baseline in PASI Total Score at Week 16
Tijdsspanne: 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 was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
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 at Week 16 Among Participants With a Baseline sPGA-G Score >=2
Tijdsspanne: Week 16
The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Higher score indicates more severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and a >=2-grade Improvement at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
Tijdsspanne: Week 16
The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet. hf-PFA was categorized from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher score indicates more severity. Meeting the hf-PGA 0 or 1 criteria defined as having an hf-PGA score of clear (0) or almost clear (1) and a >=2-grade improvement from baseline. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With a Baseline mNAPSI Score >0
Tijdsspanne: Baseline (Week 0), Week 16
Percent change from baseline in mNAPSI score at week 16 was reported. The mNAPSI was an index used for assessing and grading the severity of nail psoriasis. Each of the participant's ten fingernails were evaluated on 7 features. The first three features were each scored from 0 to 3 in severity and were 1 = onycholysis and oil-drop dyschromia, 2 = pitting, and 3 = nail plate crumbling. Next four features was each scored 0 absent or 1 present, and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in lunula. Each fingernail was rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). Total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). Higher the score the more severe the nail bed psoriasis. Baseline = closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With Baseline f-PGA Score >=2
Tijdsspanne: Week 16
Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in PSSD Symptom Score at Week 16
Tijdsspanne: Baseline (Week 0), Week 16
Change from baseline in PSSD symptoms score at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. 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
Tijdsspanne: Baseline (Week 0), Week 16
Change from baseline in PSSD sign score at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Change From Baseline in Total DLQI Score at Week 16
Tijdsspanne: 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
Change From Baseline in Domain Scores of the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
Tijdsspanne: Baseline (Week 0), Week 16
PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T-score=more of concept being measured i.e. higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 24 Among Participants With Baseline Symptom Score >0
Tijdsspanne: Week 24
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date
Week 24
Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24
Tijdsspanne: Week 24 up to Week 160
Week 24 up to Week 160
Percentage of Participants Who Achieved PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24
Tijdsspanne: Week 24 up to Week 160
Week 24 up to Week 160
Percentage of Participants Who Achieved IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24
Tijdsspanne: Week 24 up to Week 160
Week 24 up to Week 160
Number of Participants With Adverse Events (AEs)
Tijdsspanne: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Serious Adverse Events (SAEs)
Tijdsspanne: From Week 0 to Week 160
From Week 0 to Week 160

Medewerkers en onderzoekers

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Sponsor

Janssen Research & Development, LLC

Onderzoekers

  • Studie directeur: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC

Publicaties en nuttige links

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Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2024

Primaire voltooiing (Werkelijk)

17 september 2024

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

14 november 2023

Eerst ingediend dat voldeed aan de QC-criteria

16 november 2023

Eerst geplaatst (Werkelijk)

22 november 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 77242113PSO3002 (Andere identificatie: Janssen Research & Development, LLC)

Plan Individuele Deelnemersgegevens (IPD)

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JA

Beschrijving IPD-plan

Het beleid voor het delen van gegevens van de Janssen Pharmaceutical Companies van Johnson & Johnson is beschikbaar op www.janssen.com/clinical-trials/transparency. Zoals vermeld op deze site, kunnen verzoeken om toegang tot de onderzoeksgegevens worden ingediend via de Yale Open Data Access (YODA) Project-site op yoda.yale.edu

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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