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JNJ-77242113 治疗中度至重度斑块状银屑病参与者的研究（ICONIC-ADVANCE 2）

2026年8月27日 更新者：Janssen Research & Development, LLC

一项 3 期多中心、随机、双盲、安慰剂对照和 Deucravacitinib 活性对照对照研究，旨在评估 JNJ-77242113 治疗中度至重度斑块状银屑病参与者的疗效和安全性

该研究的目的是评估与安慰剂和 deucravacitinib 相比，JNJ-77242113 对中度至重度斑块状银屑病参与者的有效性。

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

731

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • British Columbia
      • Surrey、British Columbia、加拿大、V3R 6A7
        • Dr. Chih ho Hong Medical
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3M 3Z4
        • Wiseman Dermatology Research Inc.
    • Ontario
      • London、Ontario、加拿大、N6A 5R9
        • Lovegrove Dermatology
      • Markham、Ontario、加拿大、L3P 1X2
        • Lynderm Research Inc.
      • Mississauga、Ontario、加拿大、L4Y 4C5
        • DermEdge Research
      • Peterborough、Ontario、加拿大、K9J 5K2
        • SKiN Centre for Dermatology
      • Toronto、Ontario、加拿大、M3H 5Y8
        • Toronto Research Centre
      • Toronto、Ontario、加拿大、M2N 3A6
        • North York Research Inc
      • Windsor、Ontario、加拿大、N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal、Quebec、加拿大、H2X 2V1
        • Innovaderm Research Inc.
      • Québec、Quebec、加拿大、G1V 4X7
        • Centre de Recherche Dermatologique du Quebec metropolitain
  • 匈牙利
      • Budapest、匈牙利、1152
        • Uno Medical Trials Ltd.
      • Gyula、匈牙利、5700
        • Synexus Magyarorszag Kft
      • Gyöngyös、匈牙利、3200
        • Bugat Pal Korhaz
      • Kecskemét、匈牙利、6000
        • Bacs Kiskun Varmegyei Oktatokorhaz
      • Zalaegerszeg、匈牙利、H-8900
        • Synexus Magyarorszag Kft 1
  • 台湾
      • Kaohsiung City、台湾、81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City、台湾、80756
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Taichung、台湾、40705
        • Taichung Veterans General Hospital
      • Taichung、台湾、40201
        • Chung Shan Medical University Hospital
      • Tainan、台湾、710
        • National Cheng Kung University Hospital
      • Taipei、台湾、110
        • Taipei Medical University
      • Taipei、台湾、116
        • Taipei Municipal Wanfang Hospital
  • 巴西
      • Botucatu、巴西、18618-686
        • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
      • Brasília、巴西、72145-450
        • Chronos Clinica Medica Ltda
      • Ribeirão Preto、巴西、14051140
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
      • São José do Rio Preto、巴西、15090-000
        • Funfarme Sjrp
      • São Paulo、巴西、05403 900
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
      • São Paulo、巴西、09060-870
        • Cepes - Fmabc
  • 德国
      • Augsburg、德国、86150
        • Hautarztpraxis Dr. Mihaescu
      • Bad Bentheim、德国、48455
        • Fachklinik Bad Bentheim
      • Berlin、德国、13627
        • CRS Clinical Research Services Berlin GMBH
      • Bochum、德国、44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt、德国、64283
        • Klinikum Darmstadt GmbH - Hautklinik
      • Dresden、德国、01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Dülmen、德国、48249
        • Hautzentrum Dulmen
      • Düsseldorf、德国、40212
        • Privatpraxis Dr. Hilton & Partner
      • Friedrichshafen、德国、88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Hamburg、德国、20095
        • Eurofins bioskin GmbH
      • Heidelberg、德国、69120
        • Universitaetsklinikum Heidelberg
      • Mahlow、德国、15831
        • Hautarztpraxis
      • Mainz、德国、55131
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
      • Merzig、德国、66663
        • Hautmedizin Saar Science Hms GmbH
      • Münster、德国、48149
        • Universitaetsklinikum Muenster
      • Oldenburg、德国、26133
        • Klinikum Oldenburg
      • Witten、德国、58453
        • Hautarztpraxis 1
      • Wuppertal、德国、42287
        • CentroDerm GmbH
  • 波兰
      • Bialystok、波兰、15 797
        • Renew Clinic
      • Katowice、波兰、40 568
        • CaRe Clinic
      • Katowice、波兰、40 611
        • Centrum Medyczne Angelius Provita
      • Kielce、波兰、25-316
        • Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
      • Krakow、波兰、30-002
        • SGD s.c.
      • Krakow、波兰、30-303
        • Krakowskie Centrum Badan Klinicznych
      • Krakow、波兰、30-348
        • Jagiellonskie Centrum Innowacji
      • Krakow、波兰、31 559
        • Diamond Clinic
      • Olsztyn、波兰、10-117
        • Etyka Osrodek Badan Klinicznych
      • Warsaw、波兰、02-962
        • Royalderm Agnieszka Nawrocka
      • Warsaw、波兰、02 661
        • Carpe Diem Centrum Medycyny Estetycznej
      • Warsaw、波兰、02 672
        • Synexus Polska Sp z o o Oddzial w Warszawie
      • Wroclaw、波兰、51 685
        • WroMedica I Bielicka A Strzalkowska s c
  • 澳大利亚
      • Benowa、澳大利亚、4217
        • The Skin Centre
      • Clayton、澳大利亚、3168
        • Monash Medical Centre
      • Kogarah、澳大利亚、2217
        • Premier Specialists
      • Melbourne、澳大利亚、3004
        • The Alfred Hospital
      • Mitcham、澳大利亚、3132
        • ISHI dermatology
      • Parkville、澳大利亚、3050
        • Royal Melbourne Hospital
  • 罗马尼亚
      • Cluj-Napoca、罗马尼亚、400105
        • Cabinet Medical Dermato-Venerologie
      • Craiova、罗马尼亚、200541
        • Centrul Medical Vitaplus
      • Craiova、罗马尼亚、200642
        • Spitalul Clinic Județean de Urgență
      • Iași、罗马尼亚、700381
        • Sc Iasiprest Srl
      • Oradea、罗马尼亚、410167
        • Spitalul Clinic Judetean De Urgenta Bihor
      • Timișoara、罗马尼亚、300757
        • New Derm Clinic
      • Târgu Mureş、罗马尼亚、540342
        • Spitalul Clinic Judetean Mures
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85032
        • Alliance Dermatology and MOHS Center P C
    • California
      • Encinitas、California、美国、92024
        • California Dermatology & Clinical Research Institute
      • Encino、California、美国、91436
        • T Joseph Raoof Md Inc
      • Fresno、California、美国、93701
        • Ucsf Fresno
      • Los Angeles、California、美国、90056
        • Wallace Medical Group, Inc
      • Los Angeles、California、美国、90024
        • University of California Los Angeles - Division of Dermatology
      • Oceanside、California、美国、92056
        • Dermatologist Medical Group of North County, Inc.
    • Florida
      • Miami、Florida、美国、33155
        • Bioclinical Research Alliance Inc.
      • Miami、Florida、美国、33133
        • Miami Dermatology And Laser Institute
      • Tampa、Florida、美国、33613
        • Forcare Clinical Research Inc
    • Georgia
      • Douglasville、Georgia、美国、30135
        • Southeast Dermatology Specialists
    • Illinois
      • Rolling Meadows、Illinois、美国、60008
        • Arlington Dermatology
    • Kentucky
      • Louisville、Kentucky、美国、40217
        • Skin Sciences, PLLC
      • Owensboro、Kentucky、美国、42301
        • Qualmedica Research
    • Maryland
      • Rockville、Maryland、美国、20850
        • DermAssociates, PC
    • Massachusetts
      • Brighton、Massachusetts、美国、02135
        • Metro Boston Clinical Partners
      • Methuen、Massachusetts、美国、01844
        • ActivMed Practices and Research
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan
      • Bay City、Michigan、美国、48706
        • Great Lakes Research Group
      • Caledonia、Michigan、美国、49316
        • The Derm Institute of West Michigan
      • Canton、Michigan、美国、48187
        • Hamzavi Dermatology
      • Troy、Michigan、美国、48084
        • Somerset Skin Centre
    • Missouri
      • Kirksville、Missouri、美国、63501
        • Cleaver Dermatology
    • Ohio
      • Bexley、Ohio、美国、43209
        • Bexley Dermatology Research
    • Oklahoma
      • Tulsa、Oklahoma、美国、74137
        • Essential Medical Research
    • Oregon
      • Portland、Oregon、美国、97210-2996
        • Oregon Dermatology & Research Center
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19103
        • Paddington Testing Co, Inc.
    • South Carolina
      • Charleston、South Carolina、美国、29407
        • Clinical Research Center of the Carolinas LLC
      • Greenville、South Carolina、美国、29615
        • Palmetto Clinical Trial Services, LLC
    • Texas
      • Arlington、Texas、美国、76011
        • Arlington Research Center, inc.
      • Dallas、Texas、美国、75390
        • UT Southwestern Medical Center
      • San Antonio、Texas、美国、78229
        • Dermatology Clinical Research Center of San Antonio
      • Webster、Texas、美国、77598
        • Center for Clinical Studies
    • Utah
      • Bountiful、Utah、美国、84010
        • Cope Family Medicine - Ogden Clinic
      • Springville、Utah、美国、84663
        • Springville Dermatology CCT Research
      • West Valley City、Utah、美国、84120
        • Kalo Clinical Research
    • Virginia
      • Norfolk、Virginia、美国、23502
        • Virginia Dermatology Skin Cancer Center Pllc
  • 西班牙
      • Alcorcón、西班牙、28922
        • Hosp. Univ. Fundacion Alcorcon
      • Badalona、西班牙、08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona、西班牙、08036
        • Hosp Clinic de Barcelona
      • Manises、西班牙、46940
        • Hosp. de Manises
      • Salamanca、西班牙、37007
        • Hosp Clinico Univ de Salamanca
      • Santiago de Compostela、西班牙、15702
        • Clinica Gaias
      • Santiago de Compostela、西班牙、15706
        • Hosp. Clinico Univ. de Santiago
      • Seville、西班牙、41009
        • Hosp. Virgen Macarena
      • Seville、西班牙、41014
        • Hosp. Ntra. Sra. de Valme
      • Villajoyosa、西班牙、03570
        • Hosp. de La Marina Baixa
      • Zaragoza、西班牙、50009
        • Hosp. Clinico Univ. Lozano Blesa
  • 韩国
      • Ansan-si、韩国、15355
        • Korea University Ansan Hospital
      • Anyang-si、韩国、14068
        • Hallym University Sacred Heart Hospital
      • Bucheon-si、韩国、14647
        • The Catholic University of Korea Bucheon St Mary s Hospital
      • Gwangju、韩国、61453
        • Chosun University Hospital
      • Seongnam、韩国、13496
        • CHA Bundang Medical Center, CHA University
      • Seoul、韩国、05505
        • Asan Medical Center
      • Seoul、韩国、8308
        • Korea University Guro Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  • 在首次实施研究干预前至少 26 周诊断为斑块型银屑病，伴或不伴银屑病关节炎 (PsA)
  • 筛选和基线时的总体表面积 (BSA) 大于或等于 (>=)10% (%)
  • 筛选和基线时银屑病总面积和严重程度指数 (PASI) >=12
  • 筛选和基线时的总体研究者总体评估 (IGA) >=3
  • 斑块状银屑病光疗或全身治疗的候选者

排除标准：

  • 非斑块型牛皮癣（例如，红皮病型、点滴型或脓疱型）
  • 当前药物诱发的牛皮癣（例如，新发牛皮癣或因 β 受体阻滞剂、钙通道阻滞剂或锂而导致牛皮癣恶化）
  • 当前诊断为严重、进行性或不受控制的肾脏、肝脏、心脏、血管、肺、胃肠道、内分泌、神经、血液、风湿、精神或代谢紊乱的体征或症状
  • 已知对 JNJ-77242113 或其赋形剂过敏、超敏或不耐受
  • 筛选前 8 周内进行过重大外科手术（例如，需要全身麻醉），或者尚未从外科手术中完全恢复，或者在参与者预计参加研究期间计划进行外科手术

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：JNJ-77242113
参与者将从第 0 周到第 156 周接受 JNJ-77242113，并从第 0 周到第 24 周接受 deucravacitinib 匹配的安慰剂。
药品：JNJ-77242113
JNJ-77242113将口服给药。
药品：Deucravacitinib 匹配安慰剂
Deucravacitinib 匹配安慰剂将口服给药。
安慰剂比较：安慰剂
参与者将从第 0 周到第 16 周接受 JNJ-77242113 的匹配安慰剂，从第 0 周到第 24 周接受 deucravacitinib 的匹配安慰剂，从第 16 周到第 156 周接受 JNJ-77242113 的匹配安慰剂。
药品：JNJ-77242113
JNJ-77242113将口服给药。
药品：JNJ-77242113 匹配安慰剂
JNJ-77242113 匹配的安慰剂将口服给药。
药品：Deucravacitinib 匹配安慰剂
Deucravacitinib 匹配安慰剂将口服给药。
有源比较器：德克拉伐替尼
参与者将从第 0 周到第 24 周接受 deucravacitinib，从第 0 周到第 24 周接受 JNJ-77242113 的匹配安慰剂，从第 24 周到第 156 周接受 JNJ-77242113 的匹配安慰剂。
药品：JNJ-77242113
JNJ-77242113将口服给药。
药品：JNJ-77242113 匹配安慰剂
JNJ-77242113 匹配的安慰剂将口服给药。
药品：德克拉伐替尼
Deucravacitinib 将口服给药。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
大体时间：Week 16
IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and 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, greater than (>) 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; 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 the time of first study drug administration date.
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
第16周时PASI总分相对于基线的变化
大体时间：基线（第 0 周），第 16 周
在第16周时报告了PASI总分相对于基线的变化。 PASI是一种用于评估和分级银屑病皮损严重程度及其对治疗反应的系统。 在PASI系统中，身体被分为4个区域：头部、躯干、上肢和下肢。 每个区域的红斑、浸润和脱屑分别进行评估和评分，每项按0至4分评级（0=无，1=轻度，2=中度，3=重度，4=非常严重），受累范围从0（表示无受累）到6分（90%-100%受累）。 PASI产生一个数字总分，范围从0（无银屑病）到72（最严重银屑病）。 分数越高表示银屑病严重程度越高。 基线定义为首次研究药物给药日期前或当时进行的最近一次测量。
基线（第 0 周），第 16 周
Percentage of Participants Who Achieved PASI 100 Response at Week 16
大体时间：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
Change From Baseline in Body Surface Area (BSA) at Week 16
大体时间：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
Percent Change From Baseline in PASI Total Score at Week 16
大体时间：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 were 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 IGA Score of 0 at Week 16
大体时间：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 PASI 75 Response at Weeks 4 and 16
大体时间：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 were 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 Response at Week 8
大体时间：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 were 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 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
大体时间：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 Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0
大体时间：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
大体时间：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 or 1 and >=2-Grade Improvement From Baseline at Weeks 16 and 24
大体时间：Weeks 16 and 24
IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25mm; 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 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 an IGA Score of 0 at Weeks 16 and 24
大体时间：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 PASI 75 Response at Weeks 16 and 24
大体时间：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 were 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 Response at Weeks 16 and 24
大体时间：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 were 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 Response at Weeks 16 and 24
大体时间：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 PSSD Symptom Score >0
大体时间：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
Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline sPGA-G Score >=2
大体时间：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 From Baseline at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
大体时间：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
大体时间：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 a Baseline f-PGA Score >=2
大体时间：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. Baseline = 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
大体时间：Baseline (Week 0), Week 16
Change from baseline in PSSD symptoms scores 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
大体时间：Baseline (Week 0), Week 16
Change from baseline in PSSD sign scores 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
Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0
大体时间：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
大体时间：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
大体时间：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
Change From Baseline in Total DLQI Score at Week 16
大体时间：Baseline (Week 0), Week 16
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.
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
大体时间：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 that is 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 or at time of first study drug administration date.
Baseline (Week 0), 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
大体时间：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 PSSD Symptoms Score of 0 at Week 24 Among Participants With a Baseline PSSD Symptom Score >0
大体时间：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
大体时间：From Week 24 up to Week 160
From Week 24 up to Week 160
Percentage of Participants Achieving PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24
大体时间：From Week 24 up to Week 160
From Week 24 up to Week 160
Percentage of Participants Achieving IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24
大体时间：From Week 24 up to Week 160
From Week 24 up to Week 160
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
大体时间：From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
大体时间：From Week 0 to Week 160
From Week 0 to Week 160

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  • 研究主任：Janssen Research & Development, LLC Clinicaltrial、Janssen Research & Development, LLC

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研究主要日期

学习开始 (实际的)

2024年3月9日

初级完成 (实际的)

2024年11月15日

研究完成 (估计的)

2027年9月20日

研究注册日期

首次提交

2024年1月15日

首先提交符合 QC 标准的

2024年1月15日

首次发布 (实际的)

2024年1月24日

研究记录更新

最后更新发布 (实际的)

2026年8月31日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 77242113PSO3004 (其他标识符：Janssen Research & Development, LLC)
  • 2023 (美国 NIH 拨款/合同：GRAMMY Museum Foundation)
  • 2023-507039-39-00 (注册表标识符：EUCT number)

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