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Исследование JNJ-77242113 для лечения участников с бляшечным псориазом от умеренной до тяжелой степени

2 июля 2026 г. обновлено: Janssen Research & Development, LLC

Многоцентровое, рандомизированное, двойное слепое, плацебо-контролируемое и активное исследование деукравацитиниба под контролем компаратора фазы 3 для оценки эффективности и безопасности JNJ-77242113 для лечения участников с бляшечным псориазом от умеренной до тяжелой степени

Цель исследования — выяснить, насколько эффективен JNJ-77242113 у участников с бляшечным псориазом от умеренной до тяжелой степени по сравнению с плацебо и деукравацитинибом.

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

774

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Австралия
      • Campbelltown, Австралия, 5074
        • North Eastern Health Specialists
      • Canberra, Австралия, 2606
        • Paratus Clinical Research Woden
      • East Melbourne, Австралия, 3002
        • Sinclair Dermatology
      • Melbourne, Австралия, 3053
        • Skin Health Institute Inc.
      • Woolloongabba, Австралия, 4102
        • Veracity Clinical Research
  • Аргентина
      • Buenos Aires, Аргентина, B1643CRO
        • Instituto Medico De Alta Complejidad (IMAC)
      • Buenos Aires, Аргентина, C1406AGA
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • CABA, Аргентина, C1425BEA
        • Instituto de Neumonología Y Dermatología
      • Caba, Аргентина, C1199ABD
        • Hospital Italiano de Buenos Aires
      • Caba, Аргентина, C1122AAF
        • Halitus Instituto Medico S.A. - Dermatologia y Estetica
      • La Plata, Аргентина, B1900AXI
        • Hospital Italiano de La Plata
      • Rosario, Аргентина, S2000PBJ
        • Instituto Caici Srl.
      • San Miguel de Tucumán, Аргентина, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
  • Бразилия
      • Santo André, Бразилия, 09060-870
        • Fundacao do ABC Centro Universitario FMABC
  • Венгрия
      • Borgyogyaszati Klinika, Венгрия, 7632
        • Pecsi Tudomanyegyetem
      • Budapest, Венгрия, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Debrecen, Венгрия, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Венгрия, 4031
        • Derma-B Kft
      • Kaposvár, Венгрия, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
      • Szeged, Венгрия, 6720
        • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
      • Szolnok, Венгрия, 5000
        • Allergo-Derm Bakos Kft.
      • Veszprém, Венгрия, 8200
        • Medmare Egeszsegugyi Es Szolgaltato Bt.
  • Германия
      • Berlin, Германия, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Bramsche, Германия, 49565
        • Hautarztpraxis 3
      • Dresden, Германия, 01069
        • Klinische Forschung Dresden GmbH
      • Dresden, Германия, 01097
        • Praxis fuer Dermatologie und Venerologie
      • Düsseldorf, Германия, 40225
        • Universitaetsklinikum Duesseldorf
      • Hamburg, Германия, 22391
        • MensingDerma Research GmbH
      • Hamburg, Германия, 20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Kiel, Германия, 24105
        • Universitaetsklinikum Schleswig Holstein Campus Kiel
      • Langenau, Германия, 89129
        • Studienzentrum Dr Schwarz Germany
      • Leipzig, Германия, 04103
        • Universitätsklinikum Leipzig AöR
      • Lübeck, Германия, 23562
        • Universitatsklinikum Schleswig Holstein Campus Lubeck
      • Mannheim, Германия, 68167
        • Universitaetsklinikum Mannheim
      • München, Германия, 80802
        • Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
      • Potsdam, Германия, 14467
        • Hautarztpraxis 1
      • Rostock, Германия, 18057
        • Universitaetsmedizin Rostock
  • Испания
      • Alicante, Испания, 03010
        • Hosp. Gral. Univ. Dr. Balmis
      • Barakaldo, Испания, 48902
        • Hosp. Univ. de Cruces
      • Barcelona, Испания, 08041
        • Hosp. de La Santa Creu I Sant Pau
      • Granada, Испания, 18016
        • Hosp. Univ. San Cecilio
      • L'Hospitalet de Llobregat, Испания, 08907
        • Hosp. Univ. de Bellvitge
      • Madrid, Испания, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Испания, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Испания, 28031
        • Hosp. Univ. Infanta Leonor
      • Madrid, Испания, 28006
        • Hosp. Univ. de La Princesa
      • Madrid, Испания, 28046
        • Hosp. Univ. de La Paz
      • Madrid, Испания, 28002
        • Grupo Dermatologico Y Estetico Pedro Jaen
      • Valencia, Испания, 46026
        • Hosp. Univ. I Politecni La Fe
  • Канада
    • British Columbia
      • Surrey, British Columbia, Канада, V3V 0C6
        • Enverus Medical
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Канада, A1A 4Y3
        • Karma Clinical Trials Inc.
    • Ontario
      • Ajax, Ontario, Канада, L1S7K8
        • CCA Medical Research Corporation
      • Barrie, Ontario, Канада, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre
      • Hamilton, Ontario, Канада, L8N 1Y2
        • Dermatrials Research
      • Richmond Hill, Ontario, Канада, L4B1L1
        • York Dermatology Clinic and Research Centre
      • Waterloo, Ontario, Канада, N2J 1C4
        • Alliance Clinical Trials
      • Windsor, Ontario, Канада, N8T 1E6
        • XLR8 Medical Research
  • Польша
      • Bialystok, Польша, 15-351
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok, Польша, 15-375
        • Specderm Poznanska sp j
      • Elblag, Польша, 82 300
        • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
      • Krakow, Польша, 31-411
        • Centrum Medyczne PROMED
      • Krakow, Польша, 30 438
        • Centrum Medyczne dr Rajzer Sp z o o
      • Krakow, Польша, 30-002
        • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
      • Lodz, Польша, 90-338
        • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
      • Lodz, Польша, 90-265
        • Dermed Centrum Medyczne Sp z o o
      • Osielsko, Польша, 86031
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
      • Poznan, Польша, 61 731
        • Clinical Research Center sp z o o MEDIC R s k
      • Poznan, Польша, 60 529
        • SOLUMED Centrum Medyczne
      • Warsaw, Польша, 02 953
        • Klinika Ambroziak Dermatologia
      • Warsaw, Польша, 01 817
        • Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
      • Wroclaw, Польша, 51 503
        • DERMMEDICA Sp.z o.o.
      • Wroclaw, Польша, 52 416
        • Centrum Medyczne Oporow
      • Wroclaw, Польша, 51 685
        • Wro Medica
  • Соединенное Королевство
      • London, Соединенное Королевство, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Reading, Соединенное Королевство, RG1 5AN
        • Royal Berkshire Hospital
      • Salford, Соединенное Королевство, M6 8HD
        • Salford Royal Hospital
      • Southampton, Соединенное Королевство, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • Соединенные Штаты
    • Arizona
      • Phoenix, Arizona, Соединенные Штаты, 85006
        • Medical Dermatology Specialists
      • Scottsdale, Arizona, Соединенные Штаты, 85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fort Smith, Arkansas, Соединенные Штаты, 72916
        • Johnson Dermatology
    • California
      • Fountain Valley, California, Соединенные Штаты, 92708
        • First OC Dermatology
      • Fremont, California, Соединенные Штаты, 94538
        • Center for Dermatology Clinical Research
      • Sacramento, California, Соединенные Штаты, 95815
        • Integrative Skin Science and Research
      • Santa Ana, California, Соединенные Штаты, 92701
        • Southern California Dermatology
      • Santa Monica, California, Соединенные Штаты, 90403
        • Clinical Science Institute
    • Florida
      • Miami, Florida, Соединенные Штаты, 33126
        • Driven Research LLC
      • North Miami Beach, Florida, Соединенные Штаты, 33162
        • Ziaderm Research LLC
      • Ocala, Florida, Соединенные Штаты, 34470
        • Renstar Medical Research
      • Tampa, Florida, Соединенные Штаты, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Alpharetta, Georgia, Соединенные Штаты, 30022
        • Hamilton Research LLC
      • Macon, Georgia, Соединенные Штаты, 31217
        • Skin Care Physicians Of Georgia
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60602
        • DeNova Research
      • Rolling Meadows, Illinois, Соединенные Штаты, 60008
        • Arlington Dermatology
      • Skokie, Illinois, Соединенные Штаты, 60077
        • Endeavor Health
      • West Dundee, Illinois, Соединенные Штаты, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, Соединенные Штаты, 46250
        • Dawes Fretzin Clinical Research Group LLC
      • Plainfield, Indiana, Соединенные Штаты, 46168
        • Indiana Clinical Trial Center
    • Kentucky
      • Louisville, Kentucky, Соединенные Штаты, 40241
        • Dermatology Specialists
    • Louisiana
      • Lake Charles, Louisiana, Соединенные Штаты, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Boston, Massachusetts, Соединенные Штаты, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Соединенные Штаты, 48103
        • David Fivenson MD, Dermatology
      • Clarkston, Michigan, Соединенные Штаты, 48346
        • Michigan Center of Medical Research
      • Detroit, Michigan, Соединенные Штаты, 48202
        • Henry Ford Medical Center
      • Fort Gratiot, Michigan, Соединенные Штаты, 48059
        • Hamzavi Dermatology
    • Missouri
      • Saint Joseph, Missouri, Соединенные Штаты, 64506
        • MediSearch Clinical Trials
    • Nebraska
      • Omaha, Nebraska, Соединенные Штаты, 68144
        • Skin Specialists
    • Nevada
      • Las Vegas, Nevada, Соединенные Штаты, 89119
        • Fife Dermatology
    • New Hampshire
      • Portsmouth, New Hampshire, Соединенные Штаты, 03801
        • StracSkin
    • New Jersey
      • East Windsor, New Jersey, Соединенные Штаты, 08520
        • Schweiger Dermatology Group
      • Hackensack, New Jersey, Соединенные Штаты, 07601
        • Schweiger Dermatology Group 1
    • New York
      • Stony Brook, New York, Соединенные Штаты, 11790
        • Derm Research Center of New York, Inc.
    • North Carolina
      • Wilmington, North Carolina, Соединенные Штаты, 28405
        • Wilmington Dermatology Center
    • Ohio
      • Athens, Ohio, Соединенные Штаты, 45701
        • Oakview Dermatology
      • Boardman, Ohio, Соединенные Штаты, 44512
        • Optima Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Соединенные Штаты, 73170
        • Central Sooner Research
    • Oregon
      • Portland, Oregon, Соединенные Штаты, 97201
        • Oregon Medical Research Center
    • South Dakota
      • Rapid City, South Dakota, Соединенные Штаты, 57702
        • Health Concepts
    • Texas
      • Dallas, Texas, Соединенные Штаты, 75231
        • Modern Research Associates
      • Houston, Texas, Соединенные Штаты, 77004
        • Center for Clinical Studies 1
      • Houston, Texas, Соединенные Штаты, 77056
        • Austin Institute for Clinical Research 1
      • Pflugerville, Texas, Соединенные Штаты, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, Соединенные Штаты, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, Соединенные Штаты, 78213
        • Progressive Clinical Research
      • Webster, Texas, Соединенные Штаты, 77598
        • Center for Clinical Studies
    • Virginia
      • Richmond, Virginia, Соединенные Штаты, 23294
        • National Clinical Research
    • Washington
      • Mill Creek, Washington, Соединенные Штаты, 98012
        • Frontier Derm Partners CRO, LLC
      • Spokane, Washington, Соединенные Штаты, 99202
        • Premier Clinical Research
  • Тайвань
      • Hsinchu, Тайвань, 30059
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City, Тайвань, 833
        • Chang Kung Memorial Hospital
      • New Taipei City, Тайвань, 235
        • Taipei Medical University Shuang Ho Hospital
      • Taipei, Тайвань, 112
        • Taipei Veterans General Hospital
      • Taipei, Тайвань, 10048
        • National Taiwan University Hospital
      • Taipei, Тайвань, 10449
        • Taipei Mackay Memorial Hospital
      • Taoyuan, Тайвань, 33382
        • Linkou Chang Gung Memorial Hospital
  • Южная Корея
      • Busan, Южная Корея, 49241
        • Pusan National University Hospital
      • Seongnam-si, Южная Корея, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Южная Корея, 03080
        • Seoul National University Hospital
      • Seoul, Южная Корея, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Южная Корея, 05030
        • Konkuk University Medical Center
      • Seoul, Южная Корея, 04763
        • Hanyang University Medical Center
      • Seoul, Южная Корея, 130 050
        • Kyung Hee University Hospital
  • Япония
      • Fukuoka, Япония, 814-0180
        • Fukuoka University Hospital
      • Fukutsu, Япония, 811-3217
        • Hino Dermatology Clinic
      • Gifu, Япония, 501-1112
        • Gifu University Hospital
      • Ginowan, Япония, 901 2725
        • University of the Ryukyus hospital
      • Gunma, Япония, 371 8511
        • Gunma University Hospital
      • Hokkaido, Япония, 060-0033
        • JR Sapporo Hospital
      • Hokkaido, Япония, 078 8510
        • Asahikawa Medical University Hospital
      • Isehara, Япония, 259-1193
        • Tokai University Hospital
      • Itabashi Ku, Япония, 173 8606
        • Teikyo University Hospital
      • Kawasaki, Япония, 216 8511
        • St Marianna University Hospital
      • Kitakyushu-shi, Япония, 807-8556
        • Hospital of the University of Occupational and Environmental Health
      • Nagoya, Япония, 467 8602
        • Nagoya City University Hospital
      • Nishiku, Япония, 593-8324
        • Kume Clinic
      • Obihiro Shi, Япония, 080 0013
        • Takagi Dermatological Clinic
      • Osaka, Япония, 550 0006
        • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
      • Sakai, Япония, 590 0197
        • Kindai University Hospital
      • Sapporo, Япония, 060 0063
        • Sapporo Skin Clinic
      • Sendai, Япония, 980 8574
        • Tohoku University Hospital
      • Suita, Япония, 565 0871
        • The University of Osaka Hospital
      • Tachikawa, Япония, 190 0023
        • Jitaikai Tachikawa dermatology clinic
      • Takaoka Shi, Япония, 933-0871
        • Shirasaki dermatology clinic
      • Tokyo, Япония, 160-0023
        • Tokyo Medical University Hospital
      • Tsu, Япония, 514 8507
        • Mie University Hospital

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Критерии включения:

  • Диагностика бляшечного псориаза с псориатическим артритом (ПсА) или без него в течение как минимум 26 недель до первого применения исследуемого вмешательства.
  • Общая площадь поверхности тела (ОПТ) превышает или равна (>=) 10 процентам (%) на момент скрининга и исходного уровня.
  • Общая площадь и индекс тяжести псориаза (PASI) >=12 при скрининге и исходном уровне
  • Общая оценка исследователя (IGA) >=3 на момент скрининга и на исходном уровне
  • Кандидат на фототерапию или системное лечение бляшечного псориаза.

Критерий исключения:

  • Небляшечная форма псориаза (например, эритродермическая, каплевидная или пустулезная)
  • Текущий псориаз, вызванный лекарственными средствами (например, новое начало псориаза или обострение псориаза вследствие применения бета-блокаторов, блокаторов кальциевых каналов или лития)
  • Текущий диагноз или признаки или симптомы тяжелых, прогрессирующих или неконтролируемых нарушений почек, печени, сердца, сосудов, легких, желудочно-кишечного тракта, эндокринной, неврологической, гематологической, ревматологической, психиатрической или метаболической патологии.
  • Известная аллергия, гиперчувствительность или непереносимость JNJ-77242113 или его вспомогательных веществ.
  • Крупная хирургическая процедура (например, требующая общей анестезии) в течение 8 недель до скрининга, или не полностью восстановился после хирургической процедуры, или хирургическая процедура запланирована на то время, когда участник, как ожидается, будет участвовать в исследовании.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: JNJ-77242113
Участники будут получать JNJ-77242113 с 0 по 156 неделю и деукравацитиниб, соответствующий плацебо, с 0 по 24 неделю.
Лекарство: JNJ-77242113
JNJ-77242113 будет вводиться перорально.
Лекарство: Деукравацитиниб, соответствующий плацебо
Деукравацитиниб, соответствующий плацебо, будет вводиться перорально.
Плацебо Компаратор: Плацебо
Участники получат соответствующее плацебо для JNJ-77242113 с 0 по 16 неделю, соответствующее плацебо для деукравацитиниба с 0 по 24 неделю и JNJ-77242113 с 16 по 156 неделю.
Лекарство: JNJ-77242113
JNJ-77242113 будет вводиться перорально.
Лекарство: JNJ-77242113 Соответствующее плацебо
Соответствующее плацебо JNJ-77242113 будет вводиться перорально.
Лекарство: Деукравацитиниб, соответствующий плацебо
Деукравацитиниб, соответствующий плацебо, будет вводиться перорально.
Активный компаратор: Деукравацитиниб
Участники будут получать деукравацитиниб с 0 по 24 неделю и соответствующее плацебо для JNJ-77242113 с 0 по 24 неделю и JNJ-77242113 с 24 по 156 неделю.
Лекарство: JNJ-77242113
JNJ-77242113 будет вводиться перорально.
Лекарство: JNJ-77242113 Соответствующее плацебо
Соответствующее плацебо JNJ-77242113 будет вводиться перорально.
Лекарство: Деукравацитиниб
Деукравацитиниб назначают перорально.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline in Body Surface Area (BSA) at Week 16
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Week 24 up to Week 160
Week 24 up to Week 160
Number of Participants With Adverse Events (AEs)
Временное ограничение: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Serious Adverse Events (SAEs)
Временное ограничение: From Week 0 to Week 160
From Week 0 to Week 160

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Janssen Research & Development, LLC

Следователи

  • Директор по исследованиям: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC

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Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 февраля 2024 г.

Первичное завершение (Действительный)

17 сентября 2024 г.

Завершение исследования (Оцененный)

1 июня 2027 г.

Даты регистрации исследования

Первый отправленный

14 ноября 2023 г.

Впервые представлено, что соответствует критериям контроля качества

16 ноября 2023 г.

Первый опубликованный (Действительный)

22 ноября 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

7 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 77242113PSO3002 (Другой идентификатор: Janssen Research & Development, LLC)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Политика обмена данными фармацевтических компаний Janssen, входящая в состав Johnson & Johnson, доступна по адресу www.janssen.com/clinical-trials/transparency. Как отмечено на этом сайте, запросы на доступ к данным исследования можно подать через сайт Йельского проекта открытого доступа к данным (YODA) по адресу yoda.yale.edu.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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