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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

2026年11月2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

The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

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)

774

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、85006
        • Medical Dermatology Specialists
      • Scottsdale、Arizona、アメリカ、85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fort Smith、Arkansas、アメリカ、72916
        • Johnson Dermatology
    • California
      • Fountain Valley、California、アメリカ、92708
        • First OC Dermatology
      • Fremont、California、アメリカ、94538
        • Center for Dermatology Clinical Research
      • Sacramento、California、アメリカ、95815
        • Integrative Skin Science and Research
      • Santa Ana、California、アメリカ、92701
        • Southern California Dermatology
      • Santa Monica、California、アメリカ、90403
        • Clinical Science Institute
    • Florida
      • Miami、Florida、アメリカ、33126
        • Driven Research LLC
      • North Miami Beach、Florida、アメリカ、33162
        • Ziaderm Research LLC
      • Ocala、Florida、アメリカ、34470
        • Renstar Medical Research
      • Tampa、Florida、アメリカ、33613
        • Forcare Clinical Research Inc
    • Georgia
      • Alpharetta、Georgia、アメリカ、30022
        • Hamilton Research LLC
      • Macon、Georgia、アメリカ、31217
        • Skin Care Physicians of Georgia
    • Illinois
      • Chicago、Illinois、アメリカ、60602
        • DeNova Research
      • Rolling Meadows、Illinois、アメリカ、60008
        • Arlington Dermatology
      • Skokie、Illinois、アメリカ、60077
        • Endeavor Health
      • West Dundee、Illinois、アメリカ、60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis、Indiana、アメリカ、46250
        • Dawes Fretzin Clinical Research Group LLC
      • Plainfield、Indiana、アメリカ、46168
        • Indiana Clinical Trial Center
    • Kentucky
      • Louisville、Kentucky、アメリカ、40241
        • Dermatology Specialists
    • Louisiana
      • Lake Charles、Louisiana、アメリカ、70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48103
        • David Fivenson MD, Dermatology
      • Clarkston、Michigan、アメリカ、48346
        • Michigan Center of Medical Research
      • Detroit、Michigan、アメリカ、48202
        • Henry Ford Medical Center
      • Fort Gratiot、Michigan、アメリカ、48059
        • Hamzavi Dermatology
    • Missouri
      • Saint Joseph、Missouri、アメリカ、64506
        • MediSearch Clinical Trials
    • Nebraska
      • Omaha、Nebraska、アメリカ、68144
        • Skin Specialists
    • Nevada
      • Las Vegas、Nevada、アメリカ、89119
        • Fife Dermatology
    • New Hampshire
      • Portsmouth、New Hampshire、アメリカ、03801
        • StracSkin
    • New Jersey
      • East Windsor、New Jersey、アメリカ、08520
        • Schweiger Dermatology Group
      • Hackensack、New Jersey、アメリカ、07601
        • Schweiger Dermatology Group 1
    • New York
      • Stony Brook、New York、アメリカ、11790
        • Derm Research Center of New York, Inc.
    • North Carolina
      • Wilmington、North Carolina、アメリカ、28405
        • Wilmington Dermatology Center
    • Ohio
      • Athens、Ohio、アメリカ、45701
        • Oakview Dermatology
      • Boardman、Ohio、アメリカ、44512
        • Optima Research
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ、73170
        • Central Sooner Research
    • Oregon
      • Portland、Oregon、アメリカ、97201
        • Oregon Medical Research Center
    • South Dakota
      • Rapid City、South Dakota、アメリカ、57702
        • Health Concepts
    • Texas
      • Dallas、Texas、アメリカ、75231
        • Modern Research Associates
      • Houston、Texas、アメリカ、77004
        • Center for Clinical Studies 1
      • Houston、Texas、アメリカ、77056
        • Austin Institute for Clinical Research 1
      • Pflugerville、Texas、アメリカ、78660
        • Austin Institute for Clinical Research
      • San Antonio、Texas、アメリカ、78218
        • Texas Dermatology and Laser Specialists
      • San Antonio、Texas、アメリカ、78213
        • Progressive Clinical Research
      • Webster、Texas、アメリカ、77598
        • Center for Clinical Studies
    • Virginia
      • Richmond、Virginia、アメリカ、23294
        • National Clinical Research
    • Washington
      • Mill Creek、Washington、アメリカ、98012
        • Frontier Derm Partners CRO, LLC
      • Spokane、Washington、アメリカ、99202
        • Premier Clinical Research
  • アルゼンチン
      • Buenos Aires、アルゼンチン、B1643CRO
        • Instituto Medico De Alta Complejidad (IMAC)
      • Buenos Aires、アルゼンチン、C1406AGA
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • CABA、アルゼンチン、C1425BEA
        • Instituto de Neumonologia y Dermatologia
      • Caba、アルゼンチン、C1122AAF
        • Halitus Instituto Medico S.A. - Dermatologia y Estetica
      • Caba、アルゼンチン、C1199ABD
        • Hospital Italiano de Buenos Aires
      • La Plata、アルゼンチン、B1900AXI
        • Hospital Italiano de La Plata
      • Rosario、アルゼンチン、S2000PBJ
        • Instituto Caici Srl.
      • San Miguel de Tucumán、アルゼンチン、T4000AXL
        • Centro de Investigaciones Medicas Tucuman
  • イギリス
      • London、イギリス、SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Reading、イギリス、RG1 5AN
        • Royal Berkshire Hospital
      • Salford、イギリス、M6 8HD
        • Salford Royal Hospital
      • Southampton、イギリス、SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • オーストラリア
      • Campbelltown、オーストラリア、5074
        • North Eastern Health Specialists
      • Canberra、オーストラリア、2606
        • Paratus Clinical Research Woden
      • East Melbourne、オーストラリア、3002
        • Sinclair Dermatology
      • Greenslopes、オーストラリア、4120
        • Veracity Clinical Research
      • Melbourne、オーストラリア、3053
        • Skin Health Institute Inc.
  • カナダ
    • British Columbia
      • Surrey、British Columbia、カナダ、V3V 0C6
        • Enverus Medical
    • Newfoundland and Labrador
      • St. John's、Newfoundland and Labrador、カナダ、A1A 4Y3
        • Karma Clinical Trials Inc.
    • Ontario
      • Ajax、Ontario、カナダ、L1S7K8
        • CCA Medical Research Corporation
      • Barrie、Ontario、カナダ、L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre
      • Hamilton、Ontario、カナダ、L8N 1Y2
        • Dermatrials Research
      • Richmond Hill、Ontario、カナダ、L4B1L1
        • York Dermatology Clinic and Research Centre
      • Waterloo、Ontario、カナダ、N2J 1C4
        • Alliance Clinical Trials
      • Windsor、Ontario、カナダ、N8T 1E6
        • XLR8 Medical Research
  • スペイン
      • Alicante、スペイン、03010
        • Hosp. Gral. Univ. Dr. Balmis
      • Barakaldo、スペイン、48902
        • Hosp. Univ. de Cruces
      • Barcelona、スペイン、08041
        • Hosp. de La Santa Creu I Sant Pau
      • Granada、スペイン、18016
        • Hosp. Univ. San Cecilio
      • L'Hospitalet de Llobregat、スペイン、08907
        • Hosp. Univ. de Bellvitge
      • Madrid、スペイン、28041
        • Hosp. Univ. 12 de Octubre
      • Madrid、スペイン、28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid、スペイン、28031
        • Hosp. Univ. Infanta Leonor
      • Madrid、スペイン、28006
        • Hosp. Univ. de La Princesa
      • Madrid、スペイン、28046
        • Hosp. Univ. de La Paz
      • Madrid、スペイン、28002
        • Grupo Dermatologico Y Estetico Pedro Jaen
      • Valencia、スペイン、46026
        • Hosp. Univ. I Politecni La Fe
  • ドイツ
      • Berlin、ドイツ、10789
        • ISA - Interdisciplinary Study Association GmbH
      • Bramsche、ドイツ、49565
        • Hautarztpraxis 3
      • Dresden、ドイツ、01069
        • Klinische Forschung Dresden GmbH
      • Dresden、ドイツ、01097
        • Praxis fuer Dermatologie und Venerologie
      • Düsseldorf、ドイツ、40225
        • Universitaetsklinikum Duesseldorf
      • Hamburg、ドイツ、20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Hamburg、ドイツ、22391
        • MensingDerma research GmbH
      • Kiel、ドイツ、24105
        • Universitaetsklinikum Schleswig Holstein Campus Kiel
      • Langenau、ドイツ、89129
        • Studienzentrum Dr Schwarz Germany
      • Leipzig、ドイツ、04103
        • Universitatsklinikum Leipzig AOR
      • Lübeck、ドイツ、23562
        • Universitatsklinikum Schleswig Holstein Campus Lubeck
      • Mannheim、ドイツ、68167
        • Universitaetsklinikum Mannheim
      • München、ドイツ、80802
        • Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
      • Potsdam、ドイツ、14467
        • Hautarztpraxis 1
      • Rostock、ドイツ、18057
        • Universitaetsmedizin Rostock
  • ハンガリー
      • Borgyogyaszati Klinika、ハンガリー、7632
        • Pecsi Tudomanyegyetem
      • Budapest、ハンガリー、1036
        • Obudai Egeszsegugyi Centrum Kft
      • Debrecen、ハンガリー、4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen、ハンガリー、4031
        • Derma-B Kft
      • Kaposvár、ハンガリー、7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
      • Szeged、ハンガリー、6720
        • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
      • Szolnok、ハンガリー、5000
        • Allergo-Derm Bakos Kft.
      • Veszprém、ハンガリー、8200
        • Medmare Egeszsegugyi Es Szolgaltato Bt.
  • ブラジル
      • São Paulo、ブラジル、09060-870
        • Cepes - Fmabc
  • ポーランド
      • Bialystok、ポーランド、15-351
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok、ポーランド、15-375
        • Specderm Poznanska sp j
      • Elblag、ポーランド、82 300
        • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
      • Krakow、ポーランド、30 438
        • Centrum Medyczne dr Rajzer Sp z o o
      • Krakow、ポーランド、30-002
        • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
      • Krakow、ポーランド、31-411
        • Centrum Medyczne Promed
      • Lodz、ポーランド、90-338
        • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
      • Lodz、ポーランド、90-265
        • Dermed Centrum Medyczne Sp z o o
      • Osielsko、ポーランド、86031
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
      • Poznan、ポーランド、61 731
        • Clinical Research Center sp z o o MEDIC R s k
      • Poznan、ポーランド、60 529
        • SOLUMED Centrum Medyczne
      • Warsaw、ポーランド、02 953
        • Klinika Ambroziak Dermatologia
      • Warsaw、ポーランド、01 817
        • Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
      • Wroclaw、ポーランド、51 503
        • DERMMEDICA Sp.z o.o.
      • Wroclaw、ポーランド、52 416
        • Centrum Medyczne Oporow
      • Wroclaw、ポーランド、51 685
        • Wro Medica
  • 台湾
      • Hsinchu、台湾、30059
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City、台湾、833
        • Chang Kung Memorial Hospital
      • New Taipei City、台湾、235
        • Taipei Medical University Shuang Ho Hospital
      • Taipei、台湾、112
        • Taipei Veterans General Hospital
      • Taipei、台湾、10048
        • National Taiwan University Hospital
      • Taipei、台湾、10449
        • Taipei Mackay Memorial Hospital
      • Taoyuan、台湾、33382
        • Linkou Chang Gung Memorial Hospital
  • 日本
      • Fukuoka、日本、814-0180
        • Fukuoka University Hospital
      • Fukutsu、日本、811-3217
        • Hino Dermatology Clinic
      • Gifu、日本、501-1112
        • Gifu University Hospital
      • Ginowan、日本、901 2725
        • University of the Ryukyus Hospital
      • Gunma、日本、371 8511
        • Gunma University Hospital
      • Hokkaido、日本、060-0033
        • JR Sapporo Hospital
      • Hokkaido、日本、078 8510
        • Asahikawa Medical University Hospital
      • Isehara、日本、259-1193
        • Tokai University Hospital
      • Kawasaki、日本、216 8511
        • St Marianna University Hospital
      • Kitakyushu-shi、日本、807-8556
        • Hospital of the University of Occupational and Environmental Health
      • Nagoya、日本、467 8602
        • Nagoya City University Hospital
      • Nishiku、日本、593-8324
        • Kume Clinic
      • Obihiro Shi、日本、080 0013
        • Takagi Dermatological Clinic
      • Osaka、日本、550 0006
        • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
      • Sakai、日本、590 0197
        • Kindai University Hospital
      • Sapporo、日本、060 0063
        • Sapporo Skin Clinic
      • Sendai、日本、980 8574
        • Tohoku University Hospital
      • Suita、日本、565 0871
        • The University of Osaka Hospital
      • Tachikawa、日本、190 0023
        • Jitaikai Tachikawa dermatology clinic
      • Takaoka Shi、日本、933-0871
        • Shirasaki Dermatology Clinic
      • Tokyo、日本、160-0023
        • Tokyo Medical University Hospital
      • Tsu、日本、514 8507
        • Mie University Hospital
      • tabashi City、日本、173 8606
        • Teikyo University Hospital
  • 韓国
      • Busan、韓国、49241
        • Pusan National University Hospital
      • Seongnam-si、韓国、13620
        • Seoul National University Bundang Hospital
      • Seoul、韓国、03080
        • Seoul National University Hospital
      • Seoul、韓国、06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul、韓国、05030
        • Konkuk University Medical Center
      • Seoul、韓国、04763
        • Hanyang University Medical Center
      • Seoul、韓国、130 050
        • Kyung Hee University 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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
  • Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
  • Total psoriasis area and severity index (PASI) >=12 at screening and baseline
  • Total investigator global assessment (IGA) >=3 at screening and baseline
  • Candidate for phototherapy or systemic treatment for plaque psoriasis

Exclusion Criteria:

  • Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
  • Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
  • A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Known allergies, hypersensitivity, or intolerance to JNJ-77242113, deucravacitinib, or to any of the excipients or components of the study intervention
  • Major surgical procedure, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study

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

Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.
薬：JNJ-77242113

JNJ-77242113 will be administered orally.

薬：Deucravacitinib Matching Placebo

Deucravacitinib matching placebo will be administered orally.
プラセボコンパレーター：Placebo

Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.
薬：JNJ-77242113

JNJ-77242113 will be administered orally.

薬：Deucravacitinib Matching Placebo

Deucravacitinib matching placebo will be administered orally.

薬：JNJ-77242113 Matching Placebo

JNJ-77242113 matching placebo will be administered orally.
アクティブコンパレータ：Deucravacitinib

Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.
薬：JNJ-77242113

JNJ-77242113 will be administered orally.

薬：JNJ-77242113 Matching Placebo

JNJ-77242113 matching placebo will be administered orally.

薬：Deucravacitinib

Deucravacitinib will be administered orally.

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 a 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, 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
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
Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24
時間枠：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
時間枠：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
時間枠：Week 24 up to Week 160
Week 24 up to Week 160
Number of Participants With Adverse Events (AEs)
時間枠：From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Serious Adverse Events (SAEs)
時間枠：From Week 0 to Week 160
From Week 0 to Week 160
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 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
Change From Baseline in PSSD Sign Score at Week 16
時間枠：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
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 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 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 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 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 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
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 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
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
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
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 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 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 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 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
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 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
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 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
Change From Baseline in PASI Total Score at Week 16
時間枠：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
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 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
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 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
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
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. 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
時間枠：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
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
Change From Baseline in Total DLQI Score at Week 16
時間枠：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
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 Symptom Score of 0 at Week 24 Among Participants With Baseline 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

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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

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研究記録日

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主要日程の研究

研究開始 (実際)

2024年1月17日

一次修了 (実際)

2024年9月17日

研究の完了 (推定)

2027年6月1日

試験登録日

最初に提出

2023年11月14日

QC基準を満たした最初の提出物

2023年11月16日

最初の投稿 (実際)

2023年11月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11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

  • 77242113PSO3002
  • 77242113PSO3002 (その他の識別子：Janssen Research & Development, LLC)

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

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

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米国FDA規制医薬品の研究

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米国FDA規制機器製品の研究

いいえ

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