このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

中等度から重度の尋常性乾癬の参加者の治療のための JNJ-77242113 の研究 (ICONIC-ADVANCE 2)

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

中等度から重度の尋常性乾癬の参加者の治療におけるJNJ-77242113の有効性と安全性を評価するための第3相多施設共同、無作為化、二重盲検、プラセボ対照およびデュクラバシチニブ実薬比較対照対照試験

研究の目的は、中等度から重度の尋常性乾癬の参加者においてJNJ-77242113がプラセボやデウクラバシチニブと比較してどの程度有効であるかを評価することです。

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

731

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • -治験介入の最初の投与前の少なくとも26週間の、乾癬性関節炎（PsA）の有無にかかわらず、尋常性乾癬の診断
  • スクリーニング時およびベースライン時に総体表面積 (BSA) が 10 パーセント (%) 以上 (>=)
  • スクリーニング時およびベースライン時の乾癬の総面積および重症度指数（PASI）>=12
  • スクリーニング時およびベースライン時の治験責任医師総合評価 (IGA) >=3
  • 尋常性乾癬の光線療法または全身治療の候補者

除外基準:

  • 非プラーク型の乾癬（例えば、紅皮症、滴状、または膿疱性）
  • 現在の薬物誘発性乾癬（たとえば、ベータ遮断薬、カルシウムチャネル遮断薬、またはリチウムによる乾癬の新たな発症または乾癬の悪化）
  • 重度、進行性、または制御不能な腎障害、肝臓障害、心臓障害、血管障害、肺障害、胃腸障害、内分泌障害、神経障害、血液障害、リウマチ障害、精神障害、または代謝障害の現在の診断または兆候または症状
  • JNJ-77242113またはその賦形剤に対する既知のアレルギー、過敏症、または不耐症
  • -スクリーニング前8週間以内に大規模な外科的処置（例えば、全身麻酔が必要）、または外科的処置から完全に回復していない、または参加者が研究に参加すると予想される期間中に外科的処置が計画されている

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：JNJ-77242113
参加者には、第0週から第156週までJNJ-77242113が投与され、第0週から第24週までプラセボと一致するデュクラバシチニブが投与されます。
薬：JNJ-77242113
JNJ-77242113は経口投与されます。
薬：デクラバシチニブと一致するプラセボ
プラセボと一致するデュクラバシチニブは経口投与されます。
プラセボコンパレーター：プラセボ
参加者には、第0週から第16週までJNJ-77242113に対応するプラセボが投与され、第0週から第24週までデウクラバシチニブに対応するプラセボが投与され、第16週から第156週までJNJ-77242113が投与されます。
薬：JNJ-77242113
JNJ-77242113は経口投与されます。
薬：JNJ-77242113 一致するプラセボ
JNJ-77242113 に適合するプラセボが経口投与されます。
薬：デクラバシチニブと一致するプラセボ
プラセボと一致するデュクラバシチニブは経口投与されます。
アクティブコンパレータ：デウクラバシチニブ
参加者には、第0週から第24週までデウクラバシチニブが投与され、第0週から第24週までJNJ-77242113に対応するプラセボが投与され、第24週から第156週までJNJ-77242113に対応するプラセボが投与されます。
薬：JNJ-77242113
JNJ-77242113は経口投与されます。
薬：JNJ-77242113 一致するプラセボ
JNJ-77242113 に適合するプラセボが経口投与されます。
薬：デウクラバシチニブ
デウクラバシチニブは経口投与されます。

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
ベースラインからの第16週時点におけるPASI総スコアの変化
時間枠：ベースライン（週0）、週16
第16週におけるPASI総合スコアのベースラインからの変化が報告されました。 PASIは、乾癬性病変の重症度および治療への反応を評価・段階付けするために使用されるシステムでした。 PASIシステムでは、身体を4つの領域（頭部、体幹、上肢、下肢）に分けました。 各領域は、紅斑、浸潤、鱗屑について別々に評価され、それぞれ0から4のスケール（0＝なし、1＝軽度、2＝中等度、3＝重度、4＝非常に重度）で評価され、また病変の広がりは0（病変なしを示す）から6（90％～100％の病変）のスケールで評価されました。 PASIは、0（乾癬なし）から72（最大の乾癬）までの範囲の数値総合スコアを算出しました。 スコアが高いほど乾癬の重症度が高いことを示しました。 ベースラインは、最初の研究薬投与日以前またはその時点で行われた最も近い測定値として定義されました。
ベースライン（週0）、週16
Percentage of Participants Who Achieved PASI 100 Response at Week 16
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：From Week 24 up to Week 160
From Week 24 up to Week 160
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
時間枠：From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
時間枠：From Week 0 to Week 160
From Week 0 to Week 160

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Janssen Research & Development, LLC

捜査官

  • スタディディレクター：Janssen Research & Development, LLC Clinicaltrial、Janssen Research & Development, LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年3月9日

一次修了 (実際)

2024年11月15日

研究の完了 (推定)

2027年9月20日

試験登録日

最初に提出

2024年1月15日

QC基準を満たした最初の提出物

2024年1月15日

最初の投稿 (実際)

2024年1月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月31日

QC基準を満たした最後の更新が送信されました

2026年8月27日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 77242113PSO3004 (その他の識別子：Janssen Research & Development, LLC)
  • 2023 (米国 NIH グラント/契約：GRAMMY Museum Foundation)
  • 2023-507039-39-00 (レジストリ識別子：EUCT number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

ジョンソン・エンド・ジョンソンのヤンセンファーマ会社のデータ共有ポリシーは、www.janssen.com/clinical-trials/transparency でご覧いただけます。 このサイトに記載されているように、研究データへのアクセス要求は、Yale Open Data Access (YODA) プロジェクト サイト (yoda.yale.edu) から送信できます。

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する