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活発な乾癬性関節炎を伴う生物学的ネイーブな参加者におけるJNJ-77242113（icotrokinra）の有効性と安全性を評価するための研究 (ICONIC-PsA 1)

2026年11月2日 更新者：Janssen Research & Development, LLC

活性乾癬性関節炎を伴う生物学的ネイーブ参加者の治療に対するJNJ-77242113の有効性と安全性を評価するフェーズ3、多施設、無作為化、二重盲検プラセボ対照研究

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

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)

552

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
    • Arkansas
      • Jonesboro、Arkansas、アメリカ、72401
        • Arthritis and Rheumatism Associates ARA Jonesboro
    • Florida
      • DeBary、Florida、アメリカ、32713
        • Omega Research Consultants
      • Plantation、Florida、アメリカ、33324
        • Integral Rheumatology And Immunology Specialists
      • Tampa、Florida、アメリカ、33606
        • Clinical Research of West Florida
    • Illinois
      • Willowbrook、Illinois、アメリカ、60527
        • Willow Rheumatology and Wellness PLLC
    • North Carolina
      • Charlotte、North Carolina、アメリカ、28204
        • Joint and Muscle Research Institute
    • Pennsylvania
      • Duncansville、Pennsylvania、アメリカ、16635
        • Altoona Center For Clinical Research
    • Texas
      • Allen、Texas、アメリカ、75013
        • Arthritis and Rheumatology Research Institute
      • Harlingen、Texas、アメリカ、78550
        • Naiara Alvarez MD Integrative Rheumatology of South TX
  • アルゼンチン
      • Buenos Aires、アルゼンチン、C1426BOS
        • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
      • Buenos Aires、アルゼンチン、1428
        • Cosultorios Reumatologógicos Pampa
      • Buenos Aires、アルゼンチン、C1417EYG
        • Mindout Research
      • Ciudad de Buenos Aires、アルゼンチン、C1431
        • Arsema
      • Ciudad de San Miguel de Tucuman、アルゼンチン、T4000AXL
        • Centro Medico Privado de Reumatologia Tucuman
      • Córdoba、アルゼンチン、CP5000
        • Consultora Integral de Salud SRL
      • San Fernando、アルゼンチン、B1646GHP
        • MR Medicina Reumatologica
      • San Isidro、アルゼンチン、B1642IPN
        • Instituto Medico De Alta Complejidad (IMAC)
  • インド
      • Ahmedabad、インド、380060
        • Marengo Cims Hospital
      • Bhubaneswar、インド、751005
        • Apollo Hospitals
      • Hyderabad、インド、500082
        • Nizams Institute of Medical Sciences
      • Kolkata、インド、700054
        • Apollo Multispeciality Hospital Ltd
      • Mumbai、インド、400053
        • Kokilaben Dhirubhai Ambani Hsp And Med Research Inst
      • Mysuru、インド、570004
        • JSS Hospital
      • New Delhi、インド、110029
        • All India Institute of Medical Sciences
      • New Delhi、インド、1100776
        • Indraprastha Apollo Hospital
      • Noida、インド、201301
        • Fortis Hospital
      • Surat、インド、395002
        • SIDS Hospital & Research Centre
  • オーストラリア
      • Ipswich、オーストラリア、4305
        • Ipswich Hospital
      • Maroochydore、オーストラリア、4558
        • Rheumatology Research Unit
      • Parramatta、オーストラリア、2150
        • BJC Health
      • South Woodville、オーストラリア、5011
        • Queen Elizabeth Hospital
      • Tiwi、オーストラリア、0810
        • Royal Darwin Hospital
  • スペイン
      • A Coruña、スペイン、15006
        • Hosp Univ A Coruna
      • Barcelona、スペイン、8036
        • Hosp. Clinic de Barcelona
      • Barcelona、スペイン、08035
        • Hosp Univ Vall D Hebron
      • Córdoba、スペイン、14004
        • Hosp Reina Sofia
      • Madrid、スペイン、28041
        • Hosp. Univ. 12 de Octubre
      • Málaga、スペイン、29009
        • Hosp Regional Univ de Malaga
      • Sabadell、スペイン、08208
        • Corporacio Sanitari Parc Tauli
      • Santander、スペイン、39008
        • Hosp. Univ. Marques de Valdecilla
      • Seville、スペイン、41013
        • Hosp. Virgen Del Rocio
      • Seville、スペイン、41009
        • Hosp. Virgen Macarena
      • Seville、スペイン、41013
        • Hosp. Quiron Sagrado Corazon
      • Seville、スペイン、41010
        • Hosp. Infanta Luisa
  • タイ
      • Bangkok、タイ、10400
        • Phramongkutklao Hospital
      • Bangkok、タイ、10700
        • Siriraj Hospital
      • Bangkok、タイ、10400
        • Rajavithi Hospital
      • Changwat Sara Buri、タイ、18000
        • Saraburi Hospital
      • Phra Nakhon Si Ayutthaya、タイ、13000
        • Phra Nakhon Si Ayutthaya Hospital
      • Songkhla、タイ、90110
        • Songklanagarind hospital
  • チェコ
      • Brno、チェコ、63800
        • Revmatologie s r o
      • Brno-Židenice、チェコ、615 00
        • Revmacentrum MUDr Mostera s r o
      • Břeclav、チェコ、690 02
        • RHEUMA s r o
      • Hlučín、チェコ、748 01
        • L K N Arthrocentrum
      • Karvina Frystat、チェコ、73301
        • Revimex Pro s r o
      • Ostrava、チェコ、70800
        • MUDr Rosypalova s r o
      • Ostrava、チェコ、70200
        • CCR Ostrava S R O
      • Prague、チェコ、140 59
        • Thomayerova nemocnice
      • Prague、チェコ、140 00
        • Revmatologicka Ordinace
      • Prague、チェコ、150 00
        • FN Motol
      • Prague、チェコ、128 00
        • Revmatologicky ustav
      • Uherské Hradiště、チェコ、68601
        • Medical Plus S R O
      • Zlín、チェコ、76001
        • PV Medical S R O
  • デンマーク
      • Aarhus N、デンマーク、8200
        • Aarhus University Hospital
      • Esbjerg、デンマーク、6700
        • Sydvestjysk Sygehus
      • Frederiksberg、デンマーク、2000
        • Frederiksberg Hospital
      • Herning、デンマーク、7400
        • Regionshospitalet Godstrup
      • Svendborg、デンマーク、5700
        • Svendborg Hospital Odense University Hospital
      • Vejle、デンマーク、7100
        • Vejle Sygehus
  • ドイツ
      • Bad Bentheim、ドイツ、48455
        • Fachklinik Bad Bentheim
      • Berlin、ドイツ、10117
        • Charite Universitaetsmedizin Berlin
      • Berlin、ドイツ、10789
        • ISA - Interdisciplinary Study Association GmbH
      • Dresden、ドイツ、01307
        • Universitatsklinikum Carl Gustav Carus Dresden
      • Freiburg im Breisgau、ドイツ、79104
        • Medizinische Fakultat der Albert Ludwigs Universitat Freiburg
      • Hamburg、ドイツ、20095
        • Hamburger Rheuma Forschungszentrum II
      • Herne、ドイツ、44649
        • Rheumazentrum Ruhrgebiet
      • Langenau、ドイツ、89129
        • Studienzentrum Dr Schwarz Germany
      • Minden、ドイツ、32429
        • Johannes Wesling Klinikum Minden
      • Tübingen、ドイツ、72076
        • Universitatsklinikum Tubingen
  • ハンガリー
      • Budapest、ハンガリー、1036
        • Obudai Egeszsegugyi Centrum Kft
      • Budapest、ハンガリー、1036
        • Synexus Magyarorszag Kft
      • Budapest、ハンガリー、1152
        • Uno Medical Trials Ltd.
      • Budapest、ハンガリー、1027
        • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
      • Budapest、ハンガリー、1027
        • Revita Kft
      • Budapest、ハンガリー、1134
        • Qualiclinic Kft
      • Debrecen、ハンガリー、4032
        • University of Debrecen
      • Gyula、ハンガリー、5700
        • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
      • Kaposvár、ハンガリー、7400
        • Obudai Egeszsegugyi Centrum Kft 1
      • Szeged、ハンガリー、6725
        • University of Szeged
      • Szolnok、ハンガリー、5000
        • MAV Korhaz es Rendelointezet
      • Veszprém、ハンガリー、8200
        • Vital Medical Center Orvosi es Fogaszati Kozpont
  • ブルガリア
      • Haskovo、ブルガリア、6304
        • MC Medtech Services Ltd
      • Pleven、ブルガリア、5803
        • Exacta Medica
      • Plovdiv、ブルガリア、4002
        • Medical Center Artmed
      • Rousse、ブルガリア、7012
        • Medical Center Teodora
  • ポーランド
      • Bialystok、ポーランド、15-879
        • ClinicMed Daniluk Nowak Spolka Komandytowa
      • Bialystok、ポーランド、15-375
        • Specderm Poznanska sp j
      • Bialystok、ポーランド、15-351
        • Osteo Medic S C Artur Racewicz Jerzy Supronik
      • Bydgoszcz、ポーランド、85-168
        • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
      • Elblag、ポーランド、82-300
        • Centrum Kliniczno Badawcze
      • Elblag、ポーランド、82-300
        • Ambulatorium sp. z o.o.
      • Gdynia、ポーランド、81-338
        • Centrum Medyczne Pratia Gdynia
      • Krakow、ポーランド、30-727
        • Pratia MCM Krakow
      • Krakow、ポーランド、30-002
        • Malopolskie Badania Kliniczne 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、30-033
        • Centrum Medyczne All Med
      • Lodz、ポーランド、90-265
        • Dermed Centrum Medyczne Sp z o o
      • Lublin、ポーランド、20-607
        • Zespol Poradni Specjalistycznych Reumed Filia nr 1
      • Nadarzyn、ポーランド、05-830
        • NZOZ Lecznica MAK MED S C
      • Olsztyn、ポーランド、10-117
        • Etyka Osrodek Badan Klinicznych
      • Torun、ポーランド、87-100
        • MICS Centrum Medyczne Torun
      • Warsaw、ポーランド、00-874
        • MICS Centrum Medyczne Warszawa
      • Warsaw、ポーランド、02-665
        • Centrum Medyczne Reuma Park
      • Wroclaw、ポーランド、52-416
        • Centrum Medyczne Oporow
      • Wroclaw、ポーランド、51-503
        • DermMedica Sp z o o
  • 中国
      • Beijing、中国、100191
        • Peking University Third Hospital
      • Beijing、中国、100730
        • Beijing Tong Ren Hospital Capital Medical University
      • Changchun、中国、130021
        • The First Bethune Hospital of Jilin University
      • Changsha、中国、410008
        • Xiangya Hospital Central South University
      • Chengdu、中国、610041
        • West China Hospital Sichuan University
      • Chengdu、中国、610072
        • Sichuan Provincial Peoples Hospital
      • Chongqing、中国、4000016
        • The First Affiliated Hospital of Chongqing Medical University
      • Guangzhou、中国、510515
        • Nanfang Hospital of Southern Medical Hospital
      • Guiyang、中国、561113
        • The Affiliated Hospital of Guizhou Medical University
      • Linyi、中国、276002
        • Linyi City People Hospital
      • Nanchang、中国、330006
        • Jiangxi Provincial Peoples Hospital
      • Nanchang、中国、330008
        • The Second Affiliated Hospital of Nanchang University
      • Nantong、中国、226001
        • Affiliated Hospital of Nantong University
      • Pingxiang、中国、337055
        • Pingxiang People's Hospital
      • Shanghai、中国、200040
        • Huashan Hospital Fudan University
      • Shanghai、中国、200443
        • Shanghai skin disease hospital
      • Shenzhen、中国、518020
        • Shenzhen People s Hospital
      • Shijiazhuang、中国、050051
        • The Third Hospital of Hebei Medical University
      • Suzhou、中国、215000
        • Second Affiliated Hospital of Soochow University
      • Taiyuan、中国、030032
        • Shanxi Bethune Hospital
      • Wenzhou、中国、325000
        • The First Affiliated Hospital of Wenzhou Medical University
      • Xi'an、中国、710006
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Zhenjiang、中国、212001
        • Affiliated Hospital of Jiangsu University
  • 台湾
      • Hsinchu、台湾、300
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City、台湾、833
        • Chang Gung Memorial Hospital
      • Tainan、台湾、710
        • Chi Mei Medical Center Yong Kang
      • Tainan、台湾、704
        • National Cheng Kung University Hospital
      • Taipei、台湾、112
        • Taipei Veterans General Hospital
      • Taoyuan、台湾、333
        • Linkou Chang Gung Memorial Hospital
  • 日本
      • Fukuoka、日本、814 0180
        • Fukuoka University Hospital
      • Kita Gun、日本、761 0793
        • Kagawa University Hospital
      • Nagoya、日本、467 8602
        • Nagoya City University Hospital
      • Osaka、日本、550 0006
        • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
      • Sasebo、日本、857 1195
        • Sasebo Chuo Hospital
      • Sendai、日本、980 8574
        • Tohoku University Hospital
      • Tokyo、日本、181 8611
        • Kyorin University Hospital
      • Tsu、日本、514 8507
        • Mie University Hospital
      • tabashi City、日本、173 8606
        • Teikyo University Hospital
      • Ōita、日本、870 0030
        • Maeshima Rheumatology Clinic
  • 香港
      • Hong Kong、香港、000000
        • Prince of Wales 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:

  • Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening
  • Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
  • Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
  • Have active plaque psoriasis with at least one psoriatic plaque of >= 2 cm diameter or nail changes consistent with psoriasis
  • A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

Exclusion Criteria:

  • Has previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis
  • Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
  • Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
  • Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or lyme disease
  • Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments

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：Group I: Icotrokinra Dose 1

Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.
薬：Icotrokinra

Icotrokinra will be administered.

他の名前：
  • JNJ-77242113
実験的：Group II: Icotrokinra Dose 2

Participants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2.
薬：Icotrokinra

Icotrokinra will be administered.

他の名前：
  • JNJ-77242113
プラセボコンパレーター：Group III: Placebo

Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
薬：Placebo

Placebo will be administered.

薬：Icotrokinra

Icotrokinra will be administered.

他の名前：
  • JNJ-77242113
アクティブコンパレータ：Group IV: Active Reference Comparator

Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.
薬：Icotrokinra

Icotrokinra will be administered.

他の名前：
  • JNJ-77242113
薬：Active reference comparator

Active reference drug will be administered.

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
Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16
時間枠：Week 16

The ACR 20 responders are participants with an improvement of greater than or equal to (>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
Week 16

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of Participants Who Achieve Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to (>=) 3 Percent (%) and an IGA Score of >=2 at Baseline
時間枠：Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
Week 16
Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
時間枠：Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Week 16
Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
時間枠：Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants who achieved at least a 100 percent improvement from baseline in the PASI score.
Week 16
Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
時間枠：Week 16

Proportion of participants with an IGA psoriasis score of 0 or 1 and >=2 grade improvement from baseline at week 16 among participants with >=3% BSA and an IGA score of >=2 at baseline will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling, each using a 5-point scale: using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema, and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Week 16
Proportion of Participants who Achieve an ACR 50 Response at Week 16
時間枠：Week 16

The ACR 50 responders are participants with an improvement of >= 50 % from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
Week 16
Proportion of Participants who Achieve an ACR 70 Response at Week 16
時間枠：Week 16

The ACR 70 responders are participants with an improvement of >= 70 % from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
Week 16
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16
時間枠：From Baseline to Week 16

The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0-3 where 0 = least difficulty and 3 = extreme difficulty.
From Baseline to Week 16
Changes From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
時間枠：From Baseline to Week 16

SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains are averaged to calculate PCS. Total score range for PCS is 0-100 (100=highest level of physical functioning).
From Baseline to Week 16
Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline
時間枠：Week 16

Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to lateral elbow epicondyle, left and right, medial femoral condyle, left and right, and achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Resolution is defined as participants have enteritis (LEI score >0) at baseline and no enthesis (LEO score =0) at the visit (week 16).
Week 16
Change From Baseline in Enthesitis Score (LEI) at Week 16 in Participants With Enthesitis at Baseline
時間枠：From Baseline to Week 16

Enthesitis will be assessed using the LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI total scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
From Baseline to Week 16
Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline
時間枠：Week 16

Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. Resolution is defined as participants have dactylitis (score >0) at baseline and no dactylitis (score =0) at the visit (week 16).
Week 16
Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline
時間枠：From Baseline to Week 16

Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.
From Baseline to Week 16
Proportion of Participants who Achieve Minimal Disease Activity (MDA) at Week 16
時間枠：Week 16

MDA criteria are a composite of 7 outcome measures used in PsA. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures: tender joint count less than or equal to (<=) 1; swollen joint count <= 1; psoriasis activity and severity index <= 1 or body surface area <= 3; patient pain VAS score of <= 15; patient global disease activity VAS (arthritis and psoriasis) score of <= 20; health assessment questionnaire (HAQ) score <= 0.5; and tender entheseal points <= 1.
Week 16
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16
時間枠：From Baseline to Week 16

The FACIT-fatigue is a self-administered, 13-item questionnaire measuring items on tiredness, weakness, and difficulty conducting usual activities due to fatigue. Responses to all items are rated on a 5-point likert response scale ranging from 0 "not at all" to 4 "very much." The total score ranges from 0 to 52, with higher values indicating less fatigue.
From Baseline to Week 16

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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 Clinical Trial、Janssen Research & Development, LLC

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)

2025年2月21日

一次修了 (実際)

2026年5月25日

研究の完了 (推定)

2028年2月4日

試験登録日

最初に提出

2025年3月13日

QC基準を満たした最初の提出物

2025年3月13日

最初の投稿 (実際)

2025年3月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3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

  • 77242113PSA3001
  • 77242113PSA3001 (その他の識別子：Janssen Research & Development, LLC)
  • 2023-509239-19-00 (レジストリ識別子：EUCT number)
  • 2023 (米国 NIH グラント/契約)

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 Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/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

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

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