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Studie JNJ-77242113 pro léčbu účastníků se středně těžkou až těžkou plakovou psoriázou

2. července 2026 aktualizováno: Janssen Research & Development, LLC

Multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná a aktivním komparátorem kontrolovaná studie fáze 3 k vyhodnocení účinnosti a bezpečnosti JNJ-77242113 pro léčbu účastníků se středně těžkou až těžkou plakovou psoriázou

Účelem studie je zjistit, jak účinný je JNJ-77242113 u účastníků se středně těžkou až těžkou plakovou psoriázou ve srovnání s placebem a deukravacitinibem.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

774

Fáze

  • Fáze 3

Kontakty a umístění

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

Studijní místa

  • Argentina
      • Buenos Aires, Argentina, B1643CRO
        • Instituto Medico De Alta Complejidad (IMAC)
      • Buenos Aires, Argentina, C1406AGA
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • CABA, Argentina, C1425BEA
        • Instituto de Neumonología Y Dermatología
      • 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 Medicas Tucuman
  • Austrálie
      • Campbelltown, Austrálie, 5074
        • North Eastern Health Specialists
      • Canberra, Austrálie, 2606
        • Paratus Clinical Research Woden
      • East Melbourne, Austrálie, 3002
        • Sinclair Dermatology
      • Melbourne, Austrálie, 3053
        • Skin Health Institute Inc.
      • Woolloongabba, Austrálie, 4102
        • Veracity Clinical Research
  • Brazílie
      • Santo André, Brazílie, 09060-870
        • Fundacao do ABC Centro Universitario FMABC
  • Japonsko
      • Fukuoka, Japonsko, 814-0180
        • Fukuoka University Hospital
      • Fukutsu, Japonsko, 811-3217
        • Hino Dermatology Clinic
      • Gifu, Japonsko, 501-1112
        • Gifu University Hospital
      • Ginowan, Japonsko, 901 2725
        • University of the Ryukyus Hospital
      • Gunma, Japonsko, 371 8511
        • Gunma University Hospital
      • Hokkaido, Japonsko, 060-0033
        • JR Sapporo Hospital
      • Hokkaido, Japonsko, 078 8510
        • Asahikawa Medical University Hospital
      • Isehara, Japonsko, 259-1193
        • Tokai University Hospital
      • Itabashi Ku, Japonsko, 173 8606
        • Teikyo University Hospital
      • Kawasaki, Japonsko, 216 8511
        • St Marianna University Hospital
      • Kitakyushu-shi, Japonsko, 807-8556
        • Hospital of the University of Occupational and Environmental Health
      • Nagoya, Japonsko, 467 8602
        • Nagoya City University Hospital
      • Nishiku, Japonsko, 593-8324
        • Kume Clinic
      • Obihiro Shi, Japonsko, 080 0013
        • Takagi Dermatological Clinic
      • Osaka, Japonsko, 550 0006
        • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
      • Sakai, Japonsko, 590 0197
        • Kindai University Hospital
      • Sapporo, Japonsko, 060 0063
        • Sapporo Skin Clinic
      • Sendai, Japonsko, 980 8574
        • Tohoku University Hospital
      • Suita, Japonsko, 565 0871
        • The University of Osaka Hospital
      • Tachikawa, Japonsko, 190 0023
        • Jitaikai Tachikawa dermatology clinic
      • Takaoka Shi, Japonsko, 933-0871
        • Shirasaki dermatology clinic
      • Tokyo, Japonsko, 160-0023
        • Tokyo Medical University Hospital
      • Tsu, Japonsko, 514 8507
        • Mie University Hospital
  • Jižní Korea
      • Busan, Jižní Korea, 49241
        • Pusan National University Hospital
      • Seongnam-si, Jižní Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Jižní Korea, 03080
        • Seoul National University Hospital
      • Seoul, Jižní Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Jižní Korea, 05030
        • Konkuk University Medical Center
      • Seoul, Jižní Korea, 04763
        • Hanyang University Medical Center
      • Seoul, Jižní Korea, 130 050
        • Kyung Hee 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
  • Maďarsko
      • Borgyogyaszati Klinika, Maďarsko, 7632
        • Pecsi Tudomanyegyetem
      • Budapest, Maďarsko, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Debrecen, Maďarsko, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Maďarsko, 4031
        • Derma-B Kft
      • Kaposvár, Maďarsko, 7400
        • Somogy Vármegyei Kaposi Mór Oktató Kórház
      • Szeged, Maďarsko, 6720
        • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
      • Szolnok, Maďarsko, 5000
        • Allergo-Derm Bakos Kft.
      • Veszprém, Maďarsko, 8200
        • Medmare Egeszsegugyi Es Szolgaltato Bt.
  • Německo
      • Berlin, Německo, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Bramsche, Německo, 49565
        • Hautarztpraxis 3
      • Dresden, Německo, 01069
        • Klinische Forschung Dresden GmbH
      • Dresden, Německo, 01097
        • Praxis fuer Dermatologie und Venerologie
      • Düsseldorf, Německo, 40225
        • Universitaetsklinikum Duesseldorf
      • Hamburg, Německo, 22391
        • MensingDerma Research GmbH
      • Hamburg, Německo, 20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Kiel, Německo, 24105
        • Universitaetsklinikum Schleswig Holstein Campus Kiel
      • Langenau, Německo, 89129
        • Studienzentrum Dr Schwarz Germany
      • Leipzig, Německo, 04103
        • Universitätsklinikum Leipzig AöR
      • Lübeck, Německo, 23562
        • Universitatsklinikum Schleswig Holstein Campus Lubeck
      • Mannheim, Německo, 68167
        • Universitaetsklinikum Mannheim
      • München, Německo, 80802
        • Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
      • Potsdam, Německo, 14467
        • Hautarztpraxis 1
      • Rostock, Německo, 18057
        • Universitaetsmedizin Rostock
  • Polsko
      • Bialystok, Polsko, 15-351
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok, Polsko, 15-375
        • Specderm Poznanska sp j
      • Elblag, Polsko, 82 300
        • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
      • Krakow, Polsko, 31-411
        • Centrum Medyczne PROMED
      • Krakow, Polsko, 30 438
        • Centrum Medyczne dr Rajzer Sp z o o
      • Krakow, Polsko, 30-002
        • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
      • Lodz, Polsko, 90-338
        • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
      • Lodz, Polsko, 90-265
        • Dermed Centrum Medyczne Sp z o o
      • Osielsko, Polsko, 86031
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
      • Poznan, Polsko, 61 731
        • Clinical Research Center sp z o o MEDIC R s k
      • Poznan, Polsko, 60 529
        • SOLUMED Centrum Medyczne
      • Warsaw, Polsko, 02 953
        • Klinika Ambroziak Dermatologia
      • Warsaw, Polsko, 01 817
        • Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
      • Wroclaw, Polsko, 51 503
        • DERMMEDICA Sp.z o.o.
      • Wroclaw, Polsko, 52 416
        • Centrum Medyczne Oporów
      • Wroclaw, Polsko, 51 685
        • Wro Medica
  • Spojené království
      • London, Spojené království, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Reading, Spojené království, RG1 5AN
        • Royal Berkshire Hospital
      • Salford, Spojené království, M6 8HD
        • Salford Royal Hospital
      • Southampton, Spojené království, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • Spojené státy
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85006
        • Medical Dermatology Specialists
      • Scottsdale, Arizona, Spojené státy, 85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fort Smith, Arkansas, Spojené státy, 72916
        • Johnson Dermatology
    • California
      • Fountain Valley, California, Spojené státy, 92708
        • First OC Dermatology
      • Fremont, California, Spojené státy, 94538
        • Center for Dermatology Clinical Research
      • Sacramento, California, Spojené státy, 95815
        • Integrative Skin Science and Research
      • Santa Ana, California, Spojené státy, 92701
        • Southern California Dermatology
      • Santa Monica, California, Spojené státy, 90403
        • Clinical Science Institute
    • Florida
      • Miami, Florida, Spojené státy, 33126
        • Driven Research LLC
      • North Miami Beach, Florida, Spojené státy, 33162
        • Ziaderm Research LLC
      • Ocala, Florida, Spojené státy, 34470
        • Renstar Medical Research
      • Tampa, Florida, Spojené státy, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Alpharetta, Georgia, Spojené státy, 30022
        • Hamilton Research LLC
      • Macon, Georgia, Spojené státy, 31217
        • Skin Care Physicians of Georgia
    • Illinois
      • Chicago, Illinois, Spojené státy, 60602
        • DeNova Research
      • Rolling Meadows, Illinois, Spojené státy, 60008
        • Arlington Dermatology
      • Skokie, Illinois, Spojené státy, 60077
        • Endeavor Health
      • West Dundee, Illinois, Spojené státy, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, Spojené státy, 46250
        • Dawes Fretzin Clinical Research Group LLC
      • Plainfield, Indiana, Spojené státy, 46168
        • Indiana Clinical Trial Center
    • Kentucky
      • Louisville, Kentucky, Spojené státy, 40241
        • Dermatology Specialists
    • Louisiana
      • Lake Charles, Louisiana, Spojené státy, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Spojené státy, 48103
        • David Fivenson MD, Dermatology
      • Clarkston, Michigan, Spojené státy, 48346
        • Michigan Center of Medical Research
      • Detroit, Michigan, Spojené státy, 48202
        • Henry Ford Medical Center
      • Fort Gratiot, Michigan, Spojené státy, 48059
        • Hamzavi Dermatology
    • Missouri
      • Saint Joseph, Missouri, Spojené státy, 64506
        • MediSearch Clinical Trials
    • Nebraska
      • Omaha, Nebraska, Spojené státy, 68144
        • Skin Specialists
    • Nevada
      • Las Vegas, Nevada, Spojené státy, 89119
        • Fife Dermatology
    • New Hampshire
      • Portsmouth, New Hampshire, Spojené státy, 03801
        • Stracskin
    • New Jersey
      • East Windsor, New Jersey, Spojené státy, 08520
        • Schweiger Dermatology Group
      • Hackensack, New Jersey, Spojené státy, 07601
        • Schweiger Dermatology Group 1
    • New York
      • Stony Brook, New York, Spojené státy, 11790
        • Derm Research Center of New York, Inc.
    • North Carolina
      • Wilmington, North Carolina, Spojené státy, 28405
        • Wilmington Dermatology Center
    • Ohio
      • Athens, Ohio, Spojené státy, 45701
        • Oakview Dermatology
      • Boardman, Ohio, Spojené státy, 44512
        • Optima Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Spojené státy, 73170
        • Central Sooner Research
    • Oregon
      • Portland, Oregon, Spojené státy, 97201
        • Oregon Medical Research Center
    • South Dakota
      • Rapid City, South Dakota, Spojené státy, 57702
        • Health Concepts
    • Texas
      • Dallas, Texas, Spojené státy, 75231
        • Modern Research Associates
      • Houston, Texas, Spojené státy, 77004
        • Center for Clinical Studies 1
      • Houston, Texas, Spojené státy, 77056
        • Austin Institute for Clinical Research 1
      • Pflugerville, Texas, Spojené státy, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, Spojené státy, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, Spojené státy, 78213
        • Progressive Clinical Research
      • Webster, Texas, Spojené státy, 77598
        • Center for Clinical Studies
    • Virginia
      • Richmond, Virginia, Spojené státy, 23294
        • National Clinical Research
    • Washington
      • Mill Creek, Washington, Spojené státy, 98012
        • Frontier Derm Partners CRO, LLC
      • Spokane, Washington, Spojené státy, 99202
        • Premier Clinical Research
  • Tchaj-wan
      • Hsinchu, Tchaj-wan, 30059
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City, Tchaj-wan, 833
        • Chang Kung Memorial Hospital
      • New Taipei City, Tchaj-wan, 235
        • Taipei Medical University Shuang Ho Hospital
      • Taipei, Tchaj-wan, 112
        • Taipei Veterans General Hospital
      • Taipei, Tchaj-wan, 10048
        • National Taiwan University Hospital
      • Taipei, Tchaj-wan, 10449
        • Taipei Mackay Memorial Hospital
      • Taoyuan, Tchaj-wan, 33382
        • Linkou Chang Gung Memorial Hospital
  • Španělsko
      • Alicante, Španělsko, 03010
        • Hosp. Gral. Univ. Dr. Balmis
      • Barakaldo, Španělsko, 48902
        • Hosp. Univ. de Cruces
      • Barcelona, Španělsko, 08041
        • Hosp. de La Santa Creu I Sant Pau
      • Granada, Španělsko, 18016
        • Hosp. Univ. San Cecilio
      • L'Hospitalet de Llobregat, Španělsko, 08907
        • Hosp. Univ. de Bellvitge
      • Madrid, Španělsko, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Španělsko, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Španělsko, 28031
        • Hosp. Univ. Infanta Leonor
      • Madrid, Španělsko, 28006
        • Hosp. Univ. de La Princesa
      • Madrid, Španělsko, 28046
        • Hosp. Univ. de La Paz
      • Madrid, Španělsko, 28002
        • Grupo Dermatologico Y Estetico Pedro Jaen
      • Valencia, Španělsko, 46026
        • Hosp. Univ. I Politecni La Fe

Kritéria účasti

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

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

  • Diagnostika plakové psoriázy, s psoriatickou artritidou (PsA) nebo bez ní, po dobu alespoň 26 týdnů před prvním podáním studijní intervence
  • Celková plocha povrchu těla (BSA) větší nebo rovna (>=)10 procentům (%) při screeningu a výchozí hodnotě
  • Celková plocha psoriázy a index závažnosti (PASI) >=12 při screeningu a výchozí hodnotě
  • Celkové globální hodnocení zkoušejícího (IGA) >=3 při screeningu a výchozí hodnotě
  • Kandidát na fototerapii nebo systémovou léčbu ložiskové psoriázy

Kritéria vyloučení:

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

Studijní plán

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

Jak je studie koncipována?

Detaily designu

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

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: JNJ-77242113
Účastníci dostanou JNJ-77242113 od týdne 0 do týdne 156 a deukravacitinib odpovídající placebo od týdne 0 do týdne 24.
Lék: JNJ-77242113
JNJ-77242113 bude podáván orálně.
Lék: Deukravacitinib odpovídající placebu
Deukravacitinib odpovídající placebo bude podáváno perorálně.
Komparátor placeba: Placebo
Účastníci obdrží odpovídající placebo pro JNJ-77242113 od týdne 0 do týdne 16, odpovídající placebo pro deukravacitinib od týdne 0 do týdne 24 a JNJ-77242113 od týdne 16 do týdne 156.
Lék: JNJ-77242113
JNJ-77242113 bude podáván orálně.
Lék: JNJ-77242113 Odpovídající placebo
JNJ-77242113 odpovídající placebo bude podáváno orálně.
Lék: Deukravacitinib odpovídající placebu
Deukravacitinib odpovídající placebo bude podáváno perorálně.
Aktivní komparátor: Deukravacitinib
Účastníci budou dostávat deukravacitinib od týdne 0 do týdne 24 a odpovídající placebo pro JNJ-77242113 od týdne 0 do týdne 24 a JNJ-77242113 od týdne 24 do týdne 156.
Lék: JNJ-77242113
JNJ-77242113 bude podáván orálně.
Lék: JNJ-77242113 Odpovídající placebo
JNJ-77242113 odpovídající placebo bude podáváno orálně.
Lék: Deukravacitinib
Deukravacitinib bude podáván perorálně.

Co je měření studie?

Primární výstupní opatření

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

Sekundární výstupní opatření

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Janssen Research & Development, LLC

Vyšetřovatelé

  • Ředitel studie: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC

Publikace a užitečné odkazy

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Termíny studijních záznamů

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

Hlavní termíny studia

Začátek studia (Aktuální)

1. února 2024

Primární dokončení (Aktuální)

17. září 2024

Dokončení studie (Odhadovaný)

1. června 2027

Termíny zápisu do studia

První předloženo

14. listopadu 2023

První předloženo, které splnilo kritéria kontroly kvality

16. listopadu 2023

První zveřejněno (Aktuální)

22. listopadu 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 77242113PSO3002 (Jiný identifikátor: Janssen Research & Development, LLC)

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