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一项评估JNJ-77242113（Icotrokinra）在具有活性牛皮癣关节炎的生物学参与者中的疗效和安全性的研究 (ICONIC-PsA 1)

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

一项第3阶段，多中心，随机，双盲，安慰剂对照研究，评估JNJ-77242113对生物学的活性牛皮癣关节炎治疗的疗效和安全性

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.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

552

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 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
  • 丹麦
      • Aarhus N、丹麦、8200
        • Aarhus University Hospital
      • Esbjerg、丹麦、6700
        • Sydvestjysk Sygehus
      • Frederiksberg、丹麦、2000
        • Frederiksberg Hospital
      • Herning、丹麦、7400
        • Regionshospitalet Godstrup
      • Svendborg、丹麦、5700
        • Svendborg Hospital Odense University Hospital
      • Vejle、丹麦、7100
        • Vejle Sygehus
  • 保加利亚
      • Haskovo、保加利亚、6304
        • MC Medtech Services Ltd
      • Pleven、保加利亚、5803
        • Exacta Medica
      • Plovdiv、保加利亚、4002
        • Medical Center Artmed
      • Rousse、保加利亚、7012
        • Medical Center Teodora
  • 匈牙利
      • Budapest、匈牙利、1036
        • Obudai Egeszsegugyi Centrum Kft
      • Budapest、匈牙利、1036
        • Synexus Magyarorszag Kft
      • Budapest、匈牙利、1152
        • Uno Medical Trials Ltd.
      • Budapest、匈牙利、1027
        • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
      • Budapest、匈牙利、1027
        • Revita Kft
      • Budapest、匈牙利、1134
        • Qualiclinic Kft
      • Debrecen、匈牙利、4032
        • University of Debrecen
      • Gyula、匈牙利、5700
        • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
      • Kaposvár、匈牙利、7400
        • Obudai Egeszsegugyi Centrum Kft 1
      • Szeged、匈牙利、6725
        • University of Szeged
      • Szolnok、匈牙利、5000
        • MAV Korhaz es Rendelointezet
      • Veszprém、匈牙利、8200
        • Vital Medical Center Orvosi es Fogaszati Kozpont
  • 印度
      • Ahmedabad、印度、380060
        • Marengo Cims Hospital
      • Bhubaneswar、印度、751005
        • Apollo Hospitals
      • Hyderabad、印度、500082
        • Nizams Institute of Medical Sciences
      • Kolkata、印度、700054
        • Apollo Multispeciality Hospital Ltd
      • Mumbai、印度、400053
        • Kokilaben Dhirubhai Ambani Hsp And Med Research Inst
      • Mysuru、印度、570004
        • JSS Hospital
      • New Delhi、印度、110029
        • All India Institute of Medical Sciences
      • New Delhi、印度、1100776
        • Indraprastha Apollo Hospital
      • Noida、印度、201301
        • Fortis Hospital
      • Surat、印度、395002
        • SIDS Hospital & Research Centre
  • 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
  • 德国
      • Bad Bentheim、德国、48455
        • Fachklinik Bad Bentheim
      • Berlin、德国、10117
        • Charite Universitaetsmedizin Berlin
      • Berlin、德国、10789
        • ISA - Interdisciplinary Study Association GmbH
      • Dresden、德国、01307
        • Universitatsklinikum Carl Gustav Carus Dresden
      • Freiburg im Breisgau、德国、79104
        • Medizinische Fakultat der Albert Ludwigs Universitat Freiburg
      • Hamburg、德国、20095
        • Hamburger Rheuma Forschungszentrum II
      • Herne、德国、44649
        • Rheumazentrum Ruhrgebiet
      • Langenau、德国、89129
        • Studienzentrum Dr Schwarz Germany
      • Minden、德国、32429
        • Johannes Wesling Klinikum Minden
      • Tübingen、德国、72076
        • Universitatsklinikum Tubingen
  • 捷克语
      • Brno、捷克语、63800
        • Revmatologie s r o
      • Brno-Židenice、捷克语、615 00
        • Revmacentrum MUDr Mostera s r o
      • Břeclav、捷克语、690 02
        • RHEUMA s r o
      • Hlučín、捷克语、748 01
        • L K N Arthrocentrum
      • Karvina Frystat、捷克语、73301
        • Revimex Pro s r o
      • Ostrava、捷克语、70800
        • MUDr Rosypalova s r o
      • Ostrava、捷克语、70200
        • CCR Ostrava S R O
      • Prague、捷克语、140 59
        • Thomayerova nemocnice
      • Prague、捷克语、140 00
        • Revmatologicka Ordinace
      • Prague、捷克语、150 00
        • FN Motol
      • Prague、捷克语、128 00
        • Revmatologicky ustav
      • Uherské Hradiště、捷克语、68601
        • Medical Plus S R O
      • Zlín、捷克语、76001
        • PV Medical S R O
  • 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
  • 波兰
      • Bialystok、波兰、15-879
        • ClinicMed Daniluk Nowak Spolka Komandytowa
      • Bialystok、波兰、15-375
        • Specderm Poznanska sp j
      • Bialystok、波兰、15-351
        • Osteo Medic S C Artur Racewicz Jerzy Supronik
      • Bydgoszcz、波兰、85-168
        • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
      • Elblag、波兰、82-300
        • Centrum Kliniczno Badawcze
      • Elblag、波兰、82-300
        • Ambulatorium sp. z o.o.
      • Gdynia、波兰、81-338
        • Centrum Medyczne Pratia Gdynia
      • Krakow、波兰、30-727
        • Pratia MCM Krakow
      • Krakow、波兰、30-002
        • Malopolskie Badania Kliniczne Sp z o o
      • Krakow、波兰、30-002
        • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
      • Krakow、波兰、30-033
        • Centrum Medyczne All Med
      • Lodz、波兰、90-265
        • Dermed Centrum Medyczne Sp z o o
      • Lublin、波兰、20-607
        • Zespol Poradni Specjalistycznych Reumed Filia nr 1
      • Nadarzyn、波兰、05-830
        • NZOZ Lecznica MAK MED S C
      • Olsztyn、波兰、10-117
        • Etyka Osrodek Badan Klinicznych
      • Torun、波兰、87-100
        • MICS Centrum Medyczne Torun
      • Warsaw、波兰、00-874
        • MICS Centrum Medyczne Warszawa
      • Warsaw、波兰、02-665
        • Centrum Medyczne Reuma Park
      • Wroclaw、波兰、52-416
        • Centrum Medyczne Oporow
      • Wroclaw、波兰、51-503
        • DermMedica Sp z o o
  • 泰国
      • Bangkok、泰国、10400
        • Phramongkutklao Hospital
      • Bangkok、泰国、10700
        • Siriraj Hospital
      • Bangkok、泰国、10400
        • Rajavithi Hospital
      • Changwat Sara Buri、泰国、18000
        • Saraburi Hospital
      • Phra Nakhon Si Ayutthaya、泰国、13000
        • Phra Nakhon Si Ayutthaya Hospital
      • Songkhla、泰国、90110
        • Songklanagarind hospital
  • 澳大利亚
      • Ipswich、澳大利亚、4305
        • Ipswich Hospital
      • Maroochydore、澳大利亚、4558
        • Rheumatology Research Unit
      • Parramatta、澳大利亚、2150
        • BJC Health
      • South Woodville、澳大利亚、5011
        • Queen Elizabeth Hospital
      • Tiwi、澳大利亚、0810
        • Royal Darwin Hospital
  • 美国
    • Arkansas
      • Jonesboro、Arkansas、美国、72401
        • Arthritis and Rheumatism Associates ARA Jonesboro
    • Florida
      • DeBary、Florida、美国、32713
        • Omega Research Consultants
      • Plantation、Florida、美国、33324
        • Integral Rheumatology And Immunology Specialists
      • Tampa、Florida、美国、33606
        • Clinical Research of West Florida
    • Illinois
      • Willowbrook、Illinois、美国、60527
        • Willow Rheumatology and Wellness PLLC
    • North Carolina
      • Charlotte、North Carolina、美国、28204
        • Joint and Muscle Research Institute
    • Pennsylvania
      • Duncansville、Pennsylvania、美国、16635
        • Altoona Center For Clinical Research
    • Texas
      • Allen、Texas、美国、75013
        • Arthritis and Rheumatology Research Institute
      • Harlingen、Texas、美国、78550
        • Naiara Alvarez MD Integrative Rheumatology of South TX
  • 西班牙
      • A Coruña、西班牙、15006
        • Hosp Univ A Coruna
      • Barcelona、西班牙、8036
        • Hosp. Clinic de Barcelona
      • Barcelona、西班牙、08035
        • Hosp Univ Vall D Hebron
      • Córdoba、西班牙、14004
        • Hosp Reina Sofia
      • Madrid、西班牙、28041
        • Hosp. Univ. 12 de Octubre
      • Málaga、西班牙、29009
        • Hosp Regional Univ de Malaga
      • Sabadell、西班牙、08208
        • Corporacio Sanitari Parc Tauli
      • Santander、西班牙、39008
        • Hosp. Univ. Marques de Valdecilla
      • Seville、西班牙、41013
        • Hosp. Virgen Del Rocio
      • Seville、西班牙、41009
        • Hosp. Virgen Macarena
      • Seville、西班牙、41013
        • Hosp. Quiron Sagrado Corazon
      • Seville、西班牙、41010
        • Hosp. Infanta Luisa
  • 阿根廷
      • Buenos Aires、阿根廷、C1426BOS
        • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
      • Buenos Aires、阿根廷、1428
        • Cosultorios Reumatologógicos Pampa
      • Buenos Aires、阿根廷、C1417EYG
        • Mindout Research
      • Ciudad de Buenos Aires、阿根廷、C1431
        • Arsema
      • Ciudad de San Miguel de Tucuman、阿根廷、T4000AXL
        • Centro Medico Privado de Reumatologia Tucuman
      • Córdoba、阿根廷、CP5000
        • Consultora Integral de Salud SRL
      • San Fernando、阿根廷、B1646GHP
        • MR Medicina Reumatologica
      • San Isidro、阿根廷、B1642IPN
        • Instituto Medico De Alta Complejidad (IMAC)
  • 香港
      • Hong Kong、香港、000000
        • Prince of Wales Hospital

参与标准

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

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

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

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Icotrokinra

Icotrokinra will be administered.

其他名称：
  • JNJ-77242113
实验性的：Group II: Icotrokinra Dose 2

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

Icotrokinra will be administered.

其他名称：
  • JNJ-77242113
安慰剂比较：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.
药品：Placebo

Placebo will be administered.

药品：Icotrokinra

Icotrokinra will be administered.

其他名称：
  • JNJ-77242113
有源比较器：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.
药品：Icotrokinra

Icotrokinra will be administered.

其他名称：
  • JNJ-77242113
药品：Active reference comparator

Active reference drug will be administered.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

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赞助

Janssen Research & Development, LLC

调查人员

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

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月21日

初级完成 (实际的)

2026年5月25日

研究完成 (估计的)

2028年2月4日

研究注册日期

首次提交

2025年3月13日

首先提交符合 QC 标准的

2025年3月13日

首次发布 (实际的)

2025年3月17日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 77242113PSA3001
  • 77242113PSA3001 (其他标识符：Janssen Research & Development, LLC)
  • 2023-509239-19-00 (注册表标识符：EUCT number)
  • 2023 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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