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능동적 성 건선 관절염을 가진 생물학적 나이브 참가자에서 JNJ-77242113 (Icotrokinra)의 효능 및 안전성을 평가하는 연구 (ICONIC-PsA 1)

2026년 11월 2일 업데이트: Janssen Research & Development, LLC

적극적인 건선 관절염을 가진 생물학적 유감 참가자의 치료를위한 JNJ-77242113의 효능 및 안전성을 평가하는 3 상, 다기관, 무작위, 이중 맹검, 위약 대조 연구

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

552

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Icotrokinra

Icotrokinra will be administered.

다른 이름들:
  • JNJ-77242113
실험적: Group II: Icotrokinra Dose 2

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

Icotrokinra will be administered.

다른 이름들:
  • JNJ-77242113
위약 비교기: 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.
의약품: Placebo

Placebo will be administered.

의약품: Icotrokinra

Icotrokinra will be administered.

다른 이름들:
  • JNJ-77242113
활성 비교기: 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.
의약품: Icotrokinra

Icotrokinra will be administered.

다른 이름들:
  • JNJ-77242113
의약품: Active reference comparator

Active reference drug will be administered.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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스폰서

Janssen Research & Development, LLC

수사관

  • 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 2월 21일

기본 완료 (실제)

2026년 5월 25일

연구 완료 (추정된)

2028년 2월 4일

연구 등록 날짜

최초 제출

2025년 3월 13일

QC 기준을 충족하는 최초 제출

2025년 3월 13일

처음 게시됨 (실제)

2025년 3월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 77242113PSA3001
  • 77242113PSA3001 (기타 식별자: Janssen Research & Development, LLC)
  • 2023-509239-19-00 (레지스트리 식별자: EUCT number)
  • 2023 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

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IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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