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Eine Studie zu JNJ-77242113 zur Behandlung von Teilnehmern mit mittelschwerer bis schwerer Plaque-Psoriasis

2. Juli 2026 aktualisiert von: Janssen Research & Development, LLC

Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte und mit Deucravacitinib aktive Vergleichsstudie der Phase 3 zur Bewertung der Wirksamkeit und Sicherheit von JNJ-77242113 zur Behandlung von Teilnehmern mit mittelschwerer bis schwerer Plaque-Psoriasis

Der Zweck der Studie besteht darin, herauszufinden, wie wirksam JNJ-77242113 bei Teilnehmern mit mittelschwerer bis schwerer Plaque-Psoriasis im Vergleich zu Placebo und Deucravacitinib ist.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

774

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien, B1643CRO
        • Instituto Medico De Alta Complejidad (IMAC)
      • Buenos Aires, Argentinien, C1406AGA
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • CABA, Argentinien, C1425BEA
        • Instituto de Neumonologia Y Dermatologia
      • Caba, Argentinien, C1199ABD
        • Hospital Italiano de Buenos Aires
      • Caba, Argentinien, C1122AAF
        • Halitus Instituto Medico S.A. - Dermatologia y Estetica
      • La Plata, Argentinien, B1900AXI
        • Hospital Italiano de La Plata
      • Rosario, Argentinien, S2000PBJ
        • Instituto Caici Srl.
      • San Miguel de Tucumán, Argentinien, 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
  • Deutschland
      • Berlin, Deutschland, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Bramsche, Deutschland, 49565
        • Hautarztpraxis 3
      • Dresden, Deutschland, 01069
        • Klinische Forschung Dresden GmbH
      • Dresden, Deutschland, 01097
        • Praxis fuer Dermatologie und Venerologie
      • Düsseldorf, Deutschland, 40225
        • Universitaetsklinikum Duesseldorf
      • Hamburg, Deutschland, 22391
        • MensingDerma Research GmbH
      • Hamburg, Deutschland, 20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Kiel, Deutschland, 24105
        • Universitaetsklinikum Schleswig Holstein Campus Kiel
      • Langenau, Deutschland, 89129
        • Studienzentrum Dr Schwarz Germany
      • Leipzig, Deutschland, 04103
        • Universitätsklinikum Leipzig AöR
      • Lübeck, Deutschland, 23562
        • Universitatsklinikum Schleswig Holstein Campus Lubeck
      • Mannheim, Deutschland, 68167
        • Universitaetsklinikum Mannheim
      • München, Deutschland, 80802
        • Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
      • Potsdam, Deutschland, 14467
        • Hautarztpraxis 1
      • Rostock, Deutschland, 18057
        • Universitaetsmedizin Rostock
  • 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
  • Kanada
    • British Columbia
      • Surrey, British Columbia, Kanada, V3V 0C6
        • Enverus Medical
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Kanada, A1A 4Y3
        • Karma Clinical Trials Inc.
    • Ontario
      • Ajax, Ontario, Kanada, L1S7K8
        • CCA Medical Research Corporation
      • Barrie, Ontario, Kanada, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre
      • Hamilton, Ontario, Kanada, L8N 1Y2
        • Dermatrials Research
      • Richmond Hill, Ontario, Kanada, L4B1L1
        • York Dermatology Clinic and Research Centre
      • Waterloo, Ontario, Kanada, N2J 1C4
        • Alliance Clinical Trials
      • Windsor, Ontario, Kanada, N8T 1E6
        • XLR8 Medical Research
  • 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
  • Südkorea
      • Busan, Südkorea, 49241
        • Pusan National University Hospital
      • Seongnam-si, Südkorea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Südkorea, 03080
        • Seoul National University Hospital
      • Seoul, Südkorea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Südkorea, 05030
        • Konkuk University Medical Center
      • Seoul, Südkorea, 04763
        • Hanyang University Medical Center
      • Seoul, Südkorea, 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
  • 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.
  • Vereinigte Staaten
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85006
        • Medical Dermatology Specialists
      • Scottsdale, Arizona, Vereinigte Staaten, 85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fort Smith, Arkansas, Vereinigte Staaten, 72916
        • Johnson Dermatology
    • California
      • Fountain Valley, California, Vereinigte Staaten, 92708
        • First OC Dermatology
      • Fremont, California, Vereinigte Staaten, 94538
        • Center for Dermatology Clinical Research
      • Sacramento, California, Vereinigte Staaten, 95815
        • Integrative Skin Science and Research
      • Santa Ana, California, Vereinigte Staaten, 92701
        • Southern California Dermatology
      • Santa Monica, California, Vereinigte Staaten, 90403
        • Clinical Science Institute
    • Florida
      • Miami, Florida, Vereinigte Staaten, 33126
        • Driven Research LLC
      • North Miami Beach, Florida, Vereinigte Staaten, 33162
        • Ziaderm Research LLC
      • Ocala, Florida, Vereinigte Staaten, 34470
        • Renstar Medical Research
      • Tampa, Florida, Vereinigte Staaten, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Alpharetta, Georgia, Vereinigte Staaten, 30022
        • Hamilton Research LLC
      • Macon, Georgia, Vereinigte Staaten, 31217
        • Skin Care Physicians of Georgia
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60602
        • DeNova Research
      • Rolling Meadows, Illinois, Vereinigte Staaten, 60008
        • Arlington Dermatology
      • Skokie, Illinois, Vereinigte Staaten, 60077
        • Endeavor Health
      • West Dundee, Illinois, Vereinigte Staaten, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46250
        • Dawes Fretzin Clinical Research Group LLC
      • Plainfield, Indiana, Vereinigte Staaten, 46168
        • Indiana Clinical Trial Center
    • Kentucky
      • Louisville, Kentucky, Vereinigte Staaten, 40241
        • Dermatology Specialists
    • Louisiana
      • Lake Charles, Louisiana, Vereinigte Staaten, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48103
        • David Fivenson MD, Dermatology
      • Clarkston, Michigan, Vereinigte Staaten, 48346
        • Michigan Center of Medical Research
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Henry Ford Medical Center
      • Fort Gratiot, Michigan, Vereinigte Staaten, 48059
        • Hamzavi Dermatology
    • Missouri
      • Saint Joseph, Missouri, Vereinigte Staaten, 64506
        • MediSearch Clinical Trials
    • Nebraska
      • Omaha, Nebraska, Vereinigte Staaten, 68144
        • Skin Specialists
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89119
        • Fife Dermatology
    • New Hampshire
      • Portsmouth, New Hampshire, Vereinigte Staaten, 03801
        • Stracskin
    • New Jersey
      • East Windsor, New Jersey, Vereinigte Staaten, 08520
        • Schweiger Dermatology Group
      • Hackensack, New Jersey, Vereinigte Staaten, 07601
        • Schweiger Dermatology Group 1
    • New York
      • Stony Brook, New York, Vereinigte Staaten, 11790
        • Derm Research Center of New York, Inc.
    • North Carolina
      • Wilmington, North Carolina, Vereinigte Staaten, 28405
        • Wilmington Dermatology Center
    • Ohio
      • Athens, Ohio, Vereinigte Staaten, 45701
        • Oakview Dermatology
      • Boardman, Ohio, Vereinigte Staaten, 44512
        • Optima Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73170
        • Central Sooner Research
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97201
        • Oregon Medical Research Center
    • South Dakota
      • Rapid City, South Dakota, Vereinigte Staaten, 57702
        • Health Concepts
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75231
        • Modern Research Associates
      • Houston, Texas, Vereinigte Staaten, 77004
        • Center for Clinical Studies 1
      • Houston, Texas, Vereinigte Staaten, 77056
        • Austin Institute for Clinical Research 1
      • Pflugerville, Texas, Vereinigte Staaten, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, Vereinigte Staaten, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, Vereinigte Staaten, 78213
        • Progressive Clinical Research
      • Webster, Texas, Vereinigte Staaten, 77598
        • Center for Clinical Studies
    • Virginia
      • Richmond, Virginia, Vereinigte Staaten, 23294
        • National Clinical Research
    • Washington
      • Mill Creek, Washington, Vereinigte Staaten, 98012
        • Frontier Derm Partners CRO, LLC
      • Spokane, Washington, Vereinigte Staaten, 99202
        • Premier Clinical Research
  • Vereinigtes Königreich
      • London, Vereinigtes Königreich, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Reading, Vereinigtes Königreich, RG1 5AN
        • Royal Berkshire Hospital
      • Salford, Vereinigtes Königreich, M6 8HD
        • Salford Royal Hospital
      • Southampton, Vereinigtes Königreich, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Diagnose von Plaque-Psoriasis mit oder ohne Psoriasis-Arthritis (PsA) für mindestens 26 Wochen vor der ersten Verabreichung der Studienintervention
  • Gesamtkörperoberfläche (BSA) größer oder gleich (>=) 10 Prozent (%) beim Screening und bei Studienbeginn
  • Gesamtfläche und Schweregrad der Psoriasis (PASI) >=12 beim Screening und bei Studienbeginn
  • Total Investigator Global Assessment (IGA) >=3 beim Screening und bei Studienbeginn
  • Kandidat für Phototherapie oder systemische Behandlung von Plaque-Psoriasis

Ausschlusskriterien:

  • Nichtplaque-Form der Psoriasis (z. B. erythrodermische, guttata oder pustulöse)
  • Aktuelle medikamenteninduzierte Psoriasis (z. B. ein neuer Ausbruch der Psoriasis oder eine Verschlimmerung der Psoriasis durch Betablocker, Kalziumkanalblocker oder Lithium)
  • Eine aktuelle Diagnose oder Anzeichen oder Symptome schwerer, fortschreitender oder unkontrollierter Nieren-, Leber-, Herz-, Gefäß-, Lungen-, Magen-Darm-, endokriner, neurologischer, hämatologischer, rheumatologischer, psychiatrischer oder metabolischer Störungen
  • Bekannte Allergien, Überempfindlichkeit oder Unverträglichkeit gegenüber JNJ-77242113 oder seinen Hilfsstoffen
  • Größerer chirurgischer Eingriff (der beispielsweise eine Vollnarkose erfordert) innerhalb von 8 Wochen vor dem Screening, oder Sie haben sich nicht vollständig von dem chirurgischen Eingriff erholt oder ein chirurgischer Eingriff ist während des Zeitraums geplant, in dem der Teilnehmer voraussichtlich an der Studie teilnehmen wird

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: JNJ-77242113
Die Teilnehmer erhalten von Woche 0 bis Woche 156 JNJ-77242113 und von Woche 0 bis Woche 24 das passende Placebo Deucravacitinib.
Arzneimittel: JNJ-77242113
JNJ-77242113 wird oral verabreicht.
Arzneimittel: Deucravacitinib passendes Placebo
Das passende Placebo zu Deucravacitinib wird oral verabreicht.
Placebo-Komparator: Placebo
Die Teilnehmer erhalten von Woche 0 bis Woche 16 das passende Placebo für JNJ-77242113, von Woche 0 bis Woche 24 das passende Placebo für Deucravacitinib und von Woche 16 bis Woche 156 das passende Placebo für JNJ-77242113.
Arzneimittel: JNJ-77242113
JNJ-77242113 wird oral verabreicht.
Arzneimittel: JNJ-77242113 Passendes Placebo
Das zu JNJ-77242113 passende Placebo wird oral verabreicht.
Arzneimittel: Deucravacitinib passendes Placebo
Das passende Placebo zu Deucravacitinib wird oral verabreicht.
Aktiver Komparator: Deucravacitinib
Die Teilnehmer erhalten Deucravacitinib von Woche 0 bis Woche 24 und das passende Placebo für JNJ-77242113 von Woche 0 bis Woche 24 und JNJ-77242113 von Woche 24 bis Woche 156.
Arzneimittel: JNJ-77242113
JNJ-77242113 wird oral verabreicht.
Arzneimittel: JNJ-77242113 Passendes Placebo
Das zu JNJ-77242113 passende Placebo wird oral verabreicht.
Arzneimittel: Deucravacitinib
Deucravacitinib wird oral verabreicht.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
Zeitfenster: Week 16
IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema, scaling, each using 5 point scale. Induration:0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25 millimeters(mm); 2=mild plaque elevation,=0.5 mm; 3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation,>1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe(4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
Zeitfenster: Week 16
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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

Sekundäre Ergebnismessungen

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

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

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Studienbeginn (Tatsächlich)

1. Februar 2024

Primärer Abschluss (Tatsächlich)

17. September 2024

Studienabschluss (Geschätzt)

1. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

14. November 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. November 2023

Zuerst gepostet (Tatsächlich)

22. November 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

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Andere Studien-ID-Nummern

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

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