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En undersøgelse af JNJ-77242113 til behandling af deltagere med moderat til svær plakpsoriasis

2. juli 2026 opdateret af: Janssen Research & Development, LLC

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

Formålet med undersøgelsen er at se, hvor effektiv JNJ-77242113 er hos deltagere med moderat til svær plakpsoriasis sammenlignet med placebo og deucravacitinib.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

774

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, B1643CRO
        • Instituto Medico De Alta Complejidad (IMAC)
      • Buenos Aires, Argentina, C1406AGA
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • CABA, Argentina, C1425BEA
        • Instituto de Neumonologia Y Dermatologia
      • Caba, Argentina, C1199ABD
        • Hospital Italiano de Buenos Aires
      • Caba, Argentina, C1122AAF
        • Halitus Instituto Medico S.A. - Dermatologia y Estetica
      • La Plata, Argentina, B1900AXI
        • Hospital Italiano de La Plata
      • Rosario, Argentina, S2000PBJ
        • Instituto Caici Srl.
      • San Miguel de Tucumán, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
  • Australien
      • Campbelltown, Australien, 5074
        • North Eastern Health Specialists
      • Canberra, Australien, 2606
        • Paratus Clinical Research Woden
      • East Melbourne, Australien, 3002
        • Sinclair Dermatology
      • Melbourne, Australien, 3053
        • Skin Health Institute Inc.
      • Woolloongabba, Australien, 4102
        • Veracity Clinical Research
  • Brasilien
      • Santo André, Brasilien, 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
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Reading, Det Forenede Kongerige, RG1 5AN
        • Royal Berkshire Hospital
      • Salford, Det Forenede Kongerige, M6 8HD
        • Salford Royal Hospital
      • Southampton, Det Forenede Kongerige, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Medical Dermatology Specialists
      • Scottsdale, Arizona, Forenede Stater, 85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fort Smith, Arkansas, Forenede Stater, 72916
        • Johnson Dermatology
    • California
      • Fountain Valley, California, Forenede Stater, 92708
        • First OC Dermatology
      • Fremont, California, Forenede Stater, 94538
        • Center for Dermatology Clinical Research
      • Sacramento, California, Forenede Stater, 95815
        • Integrative Skin Science and Research
      • Santa Ana, California, Forenede Stater, 92701
        • Southern California Dermatology
      • Santa Monica, California, Forenede Stater, 90403
        • Clinical Science Institute
    • Florida
      • Miami, Florida, Forenede Stater, 33126
        • Driven Research LLC
      • North Miami Beach, Florida, Forenede Stater, 33162
        • Ziaderm Research LLC
      • Ocala, Florida, Forenede Stater, 34470
        • Renstar Medical Research
      • Tampa, Florida, Forenede Stater, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Alpharetta, Georgia, Forenede Stater, 30022
        • Hamilton Research LLC
      • Macon, Georgia, Forenede Stater, 31217
        • Skin Care Physicians of Georgia
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60602
        • DeNova Research
      • Rolling Meadows, Illinois, Forenede Stater, 60008
        • Arlington Dermatology
      • Skokie, Illinois, Forenede Stater, 60077
        • Endeavor Health
      • West Dundee, Illinois, Forenede Stater, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46250
        • Dawes Fretzin Clinical Research Group LLC
      • Plainfield, Indiana, Forenede Stater, 46168
        • Indiana Clinical Trial Center
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40241
        • Dermatology Specialists
    • Louisiana
      • Lake Charles, Louisiana, Forenede Stater, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48103
        • David Fivenson MD, Dermatology
      • Clarkston, Michigan, Forenede Stater, 48346
        • Michigan Center of Medical Research
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Medical Center
      • Fort Gratiot, Michigan, Forenede Stater, 48059
        • Hamzavi Dermatology
    • Missouri
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • MediSearch Clinical Trials
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68144
        • Skin Specialists
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Fife Dermatology
    • New Hampshire
      • Portsmouth, New Hampshire, Forenede Stater, 03801
        • Stracskin
    • New Jersey
      • East Windsor, New Jersey, Forenede Stater, 08520
        • Schweiger Dermatology Group
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Schweiger Dermatology Group 1
    • New York
      • Stony Brook, New York, Forenede Stater, 11790
        • Derm Research Center of New York, Inc.
    • North Carolina
      • Wilmington, North Carolina, Forenede Stater, 28405
        • Wilmington Dermatology Center
    • Ohio
      • Athens, Ohio, Forenede Stater, 45701
        • Oakview Dermatology
      • Boardman, Ohio, Forenede Stater, 44512
        • Optima Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73170
        • Central Sooner Research
    • Oregon
      • Portland, Oregon, Forenede Stater, 97201
        • Oregon Medical Research Center
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57702
        • Health Concepts
    • Texas
      • Dallas, Texas, Forenede Stater, 75231
        • Modern Research Associates
      • Houston, Texas, Forenede Stater, 77004
        • Center for Clinical Studies 1
      • Houston, Texas, Forenede Stater, 77056
        • Austin Institute for Clinical Research 1
      • Pflugerville, Texas, Forenede Stater, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, Forenede Stater, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, Forenede Stater, 78213
        • Progressive Clinical Research
      • Webster, Texas, Forenede Stater, 77598
        • Center for Clinical Studies
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23294
        • National Clinical Research
    • Washington
      • Mill Creek, Washington, Forenede Stater, 98012
        • Frontier Derm Partners CRO, LLC
      • Spokane, Washington, Forenede Stater, 99202
        • Premier Clinical Research
  • 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
  • Spanien
      • Alicante, Spanien, 03010
        • Hosp. Gral. Univ. Dr. Balmis
      • Barakaldo, Spanien, 48902
        • Hosp. Univ. de Cruces
      • Barcelona, Spanien, 08041
        • Hosp. de La Santa Creu I Sant Pau
      • Granada, Spanien, 18016
        • Hosp. Univ. San Cecilio
      • L'Hospitalet de Llobregat, Spanien, 08907
        • Hosp. Univ. de Bellvitge
      • Madrid, Spanien, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spanien, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Spanien, 28031
        • Hosp. Univ. Infanta Leonor
      • Madrid, Spanien, 28006
        • Hosp. Univ. de La Princesa
      • Madrid, Spanien, 28046
        • Hosp. Univ. de La Paz
      • Madrid, Spanien, 28002
        • Grupo Dermatologico Y Estetico Pedro Jaen
      • Valencia, Spanien, 46026
        • Hosp. Univ. I Politecni La Fe
  • Sydkorea
      • Busan, Sydkorea, 49241
        • Pusan National University Hospital
      • Seongnam-si, Sydkorea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Sydkorea, 03080
        • Seoul National University Hospital
      • Seoul, Sydkorea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Sydkorea, 05030
        • Konkuk University Medical Center
      • Seoul, Sydkorea, 04763
        • Hanyang University Medical Center
      • Seoul, Sydkorea, 130 050
        • Kyung Hee University Hospital
  • 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
  • Tyskland
      • Berlin, Tyskland, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Bramsche, Tyskland, 49565
        • Hautarztpraxis 3
      • Dresden, Tyskland, 01069
        • Klinische Forschung Dresden GmbH
      • Dresden, Tyskland, 01097
        • Praxis fuer Dermatologie und Venerologie
      • Düsseldorf, Tyskland, 40225
        • Universitaetsklinikum Duesseldorf
      • Hamburg, Tyskland, 22391
        • MensingDerma Research GmbH
      • Hamburg, Tyskland, 20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Kiel, Tyskland, 24105
        • Universitaetsklinikum Schleswig Holstein Campus Kiel
      • Langenau, Tyskland, 89129
        • Studienzentrum Dr Schwarz Germany
      • Leipzig, Tyskland, 04103
        • Universitätsklinikum Leipzig AöR
      • Lübeck, Tyskland, 23562
        • Universitatsklinikum Schleswig Holstein Campus Lubeck
      • Mannheim, Tyskland, 68167
        • Universitaetsklinikum Mannheim
      • München, Tyskland, 80802
        • Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
      • Potsdam, Tyskland, 14467
        • Hautarztpraxis 1
      • Rostock, Tyskland, 18057
        • Universitaetsmedizin Rostock
  • Ungarn
      • Borgyogyaszati Klinika, Ungarn, 7632
        • Pecsi Tudomanyegyetem
      • Budapest, Ungarn, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Debrecen, Ungarn, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Ungarn, 4031
        • Derma-B Kft
      • Kaposvár, Ungarn, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
      • Szeged, Ungarn, 6720
        • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
      • Szolnok, Ungarn, 5000
        • Allergo-Derm Bakos Kft.
      • Veszprém, Ungarn, 8200
        • Medmare Egeszsegugyi Es Szolgaltato Bt.

Deltagelseskriterier

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

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Diagnose af plaque psoriasis, med eller uden psoriasisarthritis (PsA), i mindst 26 uger før den første administration af undersøgelsesintervention
  • Total kropsoverfladeareal (BSA) større end eller lig med (>=)10 procent (%) ved screening og baseline
  • Total psoriasisareal og sværhedsgradsindeks (PASI) >=12 ved screening og baseline
  • Total investigator global assessment (IGA) >=3 ved screening og baseline
  • Kandidat til fototerapi eller systemisk behandling af plaque psoriasis

Ekskluderingskriterier:

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

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: JNJ-77242113
Deltagerne vil modtage JNJ-77242113 fra uge 0 til og med uge 156 og deucravacitinib-matchende placebo fra uge 0 til og med uge 24.
Medicin: JNJ-77242113
JNJ-77242113 vil blive indgivet oralt.
Medicin: Deucravacitinib Matching Placebo
Deucravacitinib matchende placebo vil blive indgivet oralt.
Placebo komparator: Placebo
Deltagerne vil modtage matchende placebo for JNJ-77242113 fra uge 0 til uge 16, matchende placebo for deucravacitinib fra uge 0 til uge 24 og JNJ-77242113 fra uge 16 til uge 156.
Medicin: JNJ-77242113
JNJ-77242113 vil blive indgivet oralt.
Medicin: JNJ-77242113 Matchende placebo
JNJ-77242113 matchende placebo vil blive indgivet oralt.
Medicin: Deucravacitinib Matching Placebo
Deucravacitinib matchende placebo vil blive indgivet oralt.
Aktiv komparator: Deucravacitinib
Deltagerne vil modtage deucravacitinib fra uge 0 til uge 24 og matchende placebo for JNJ-77242113 fra uge 0 til uge 24 og JNJ-77242113 fra uge 24 til uge 156.
Medicin: JNJ-77242113
JNJ-77242113 vil blive indgivet oralt.
Medicin: JNJ-77242113 Matchende placebo
JNJ-77242113 matchende placebo vil blive indgivet oralt.
Medicin: Deucravacitinib
Deucravacitinib vil blive indgivet oralt.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
Tidsramme: Week 16
IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema, 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Body Surface Area (BSA) at Week 16
Tidsramme: Baseline (Week 0), Week 16
A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Tidsramme: Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants 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
Tidsramme: 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
Tidsramme: Week 16
The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived 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
Tidsramme: 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
Tidsramme: Baseline (Week 0), Week 16
Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 16
Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in PSSD Symptom Score at Week 16
Tidsramme: Baseline (Week 0), Week 16
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
Tidsramme: 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
Tidsramme: Baseline (Week 0), Week 16
Change from baseline in total DLQI score at Week 16 was reported. The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Change From Baseline in Domain Scores of the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
Tidsramme: Baseline (Week 0), Week 16
PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T-score=more of concept being measured 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 24 up to Week 160
Week 24 up to Week 160
Number of Participants With Adverse Events (AEs)
Tidsramme: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: From Week 0 to Week 160
From Week 0 to Week 160

Samarbejdspartnere og efterforskere

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Sponsor

Janssen Research & Development, LLC

Efterforskere

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

Publikationer og nyttige links

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Generelle publikationer

Datoer for undersøgelser

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

Studer store datoer

Studiestart (Faktiske)

1. februar 2024

Primær færdiggørelse (Faktiske)

17. september 2024

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

14. november 2023

Først indsendt, der opfyldte QC-kriterier

16. november 2023

Først opslået (Faktiske)

22. november 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 77242113PSO3002 (Anden identifikator: Janssen Research & Development, LLC)

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Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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