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중등도~중증 판상 건선 참가자의 치료를 위한 JNJ-77242113 연구(ICONIC-ADVANCE 2)

2026년 8월 27일 업데이트: Janssen Research & Development, LLC

중등도 내지 중증 판상 건선 참가자의 치료를 위한 JNJ-77242113의 효능과 안전성을 평가하기 위한 3상 다기관, 무작위 배정, 이중 맹검, 위약 대조 및 Deucravcitinib 활성 비교 대조 연구

연구의 목적은 JNJ-77242113이 중등도에서 중증 판상 건선 환자에게 위약 및 듀크라바시티닙과 비교하여 얼마나 효과적인지 평가하는 것입니다.

연구 개요

상태

상태

현재 모집 상태 또는 확장 액세스 상태를 나타냅니다.
모집하지 않고 적극적으로

정황

정황

연구 중인 질병, 장애, 증후군, 질환 또는 부상입니다. ClinicalTrials.gov에서 조건에는 수명, 삶의 질 및 건강 위험과 같은 기타 건강 관련 문제도 포함될 수 있습니다.

개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.

연구 유형

연구 유형

임상 연구의 특성을 설명합니다. 연구 유형에는 중재 연구(임상 시험이라고도 함), 관찰 연구(환자 등록 포함) 및 확장된 액세스가 포함됩니다.
중재적

등록 (실제)

등록

임상 연구의 참가자 수. "예상" 등록은 연구원이 연구에 필요한 참가자의 목표 수입니다.
731

단계

단계

미국 식품의약국(FDA)에서 개발한 정의에 따라 약물 또는 생물학적 제품을 연구하는 임상 시험 단계입니다. 이 단계는 연구의 목적, 참가자 수 및 기타 특성을 기반으로 합니다. 초기 1단계(이전에는 0단계로 나열됨), 1단계, 2단계, 3단계 및 4단계의 5단계가 있습니다. 해당 없음은 장치 또는 행동 개입의 시험을 포함하여 FDA에서 정의한 단계가 없는 시험을 설명하는 데 사용됩니다.
  • 3단계

연락처 및 위치

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

연구 연락처

연구 연락처

임상 연구를 위한 등록 질문에 답변할 수 있는 사람의 이름과 연락처 정보. 연구가 수행되는 각 위치에는 이러한 질문에 더 잘 대답할 수 있는 특정 연락처가 있을 수 있습니다.

연구 장소

  • 대만
      • Kaohsiung City, 대만, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, 대만, 80756
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Taichung, 대만, 40705
        • Taichung Veterans General Hospital
      • Taichung, 대만, 40201
        • Chung Shan Medical University Hospital
      • Tainan, 대만, 710
        • National Cheng Kung University Hospital
      • Taipei, 대만, 110
        • Taipei Medical University
      • Taipei, 대만, 116
        • Taipei Municipal Wanfang Hospital
  • 대한민국
      • Ansan-si, 대한민국, 15355
        • Korea University Ansan Hospital
      • Anyang-si, 대한민국, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon-si, 대한민국, 14647
        • The Catholic University of Korea Bucheon St Mary s Hospital
      • Gwangju, 대한민국, 61453
        • Chosun University Hospital
      • Seongnam, 대한민국, 13496
        • CHA Bundang Medical Center, CHA University
      • Seoul, 대한민국, 05505
        • Asan Medical Center
      • Seoul, 대한민국, 8308
        • Korea University Guro Hospital
  • 독일
      • Augsburg, 독일, 86150
        • Hautarztpraxis Dr. Mihaescu
      • Bad Bentheim, 독일, 48455
        • Fachklinik Bad Bentheim
      • Berlin, 독일, 13627
        • CRS Clinical Research Services Berlin GMBH
      • Bochum, 독일, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, 독일, 64283
        • Klinikum Darmstadt GmbH - Hautklinik
      • Dresden, 독일, 01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Dülmen, 독일, 48249
        • Hautzentrum Dulmen
      • Düsseldorf, 독일, 40212
        • Privatpraxis Dr. Hilton & Partner
      • Friedrichshafen, 독일, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Hamburg, 독일, 20095
        • Eurofins bioskin GmbH
      • Heidelberg, 독일, 69120
        • Universitaetsklinikum Heidelberg
      • Mahlow, 독일, 15831
        • Hautarztpraxis
      • Mainz, 독일, 55131
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
      • Merzig, 독일, 66663
        • Hautmedizin Saar Science Hms GmbH
      • Münster, 독일, 48149
        • Universitaetsklinikum Muenster
      • Oldenburg, 독일, 26133
        • Klinikum Oldenburg
      • Witten, 독일, 58453
        • Hautarztpraxis 1
      • Wuppertal, 독일, 42287
        • CentroDerm GmbH
  • 루마니아
      • Cluj-Napoca, 루마니아, 400105
        • Cabinet Medical Dermato-Venerologie
      • Craiova, 루마니아, 200541
        • Centrul Medical Vitaplus
      • Craiova, 루마니아, 200642
        • Spitalul Clinic Județean de Urgență
      • Iași, 루마니아, 700381
        • Sc Iasiprest Srl
      • Oradea, 루마니아, 410167
        • Spitalul Clinic Judetean De Urgenta Bihor
      • Timișoara, 루마니아, 300757
        • New Derm Clinic
      • Târgu Mureş, 루마니아, 540342
        • Spitalul Clinic Judetean Mures
  • 미국
    • Arizona
      • Phoenix, Arizona, 미국, 85032
        • Alliance Dermatology and MOHS Center P C
    • California
      • Encinitas, California, 미국, 92024
        • California Dermatology & Clinical Research Institute
      • Encino, California, 미국, 91436
        • T Joseph Raoof Md Inc
      • Fresno, California, 미국, 93701
        • Ucsf Fresno
      • Los Angeles, California, 미국, 90056
        • Wallace Medical Group, Inc
      • Los Angeles, California, 미국, 90024
        • University of California Los Angeles - Division of Dermatology
      • Oceanside, California, 미국, 92056
        • Dermatologist Medical Group of North County, Inc.
    • Florida
      • Miami, Florida, 미국, 33155
        • Bioclinical Research Alliance Inc.
      • Miami, Florida, 미국, 33133
        • Miami Dermatology And Laser Institute
      • Tampa, Florida, 미국, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Douglasville, Georgia, 미국, 30135
        • Southeast Dermatology Specialists
    • Illinois
      • Rolling Meadows, Illinois, 미국, 60008
        • Arlington Dermatology
    • Kentucky
      • Louisville, Kentucky, 미국, 40217
        • Skin Sciences, PLLC
      • Owensboro, Kentucky, 미국, 42301
        • Qualmedica Research
    • Maryland
      • Rockville, Maryland, 미국, 20850
        • DermAssociates, PC
    • Massachusetts
      • Brighton, Massachusetts, 미국, 02135
        • Metro Boston Clinical Partners
      • Methuen, Massachusetts, 미국, 01844
        • ActivMed Practices and Research
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • University of Michigan
      • Bay City, Michigan, 미국, 48706
        • Great Lakes Research Group
      • Caledonia, Michigan, 미국, 49316
        • The Derm Institute of West Michigan
      • Canton, Michigan, 미국, 48187
        • Hamzavi Dermatology
      • Troy, Michigan, 미국, 48084
        • Somerset Skin Centre
    • Missouri
      • Kirksville, Missouri, 미국, 63501
        • Cleaver Dermatology
    • Ohio
      • Bexley, Ohio, 미국, 43209
        • Bexley Dermatology Research
    • Oklahoma
      • Tulsa, Oklahoma, 미국, 74137
        • Essential Medical Research
    • Oregon
      • Portland, Oregon, 미국, 97210-2996
        • Oregon Dermatology & Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19103
        • Paddington Testing Co, Inc.
    • South Carolina
      • Charleston, South Carolina, 미국, 29407
        • Clinical Research Center of the Carolinas LLC
      • Greenville, South Carolina, 미국, 29615
        • Palmetto Clinical Trial Services, LLC
    • Texas
      • Arlington, Texas, 미국, 76011
        • Arlington Research Center, inc.
      • Dallas, Texas, 미국, 75390
        • UT Southwestern Medical Center
      • San Antonio, Texas, 미국, 78229
        • Dermatology Clinical Research Center of San Antonio
      • Webster, Texas, 미국, 77598
        • Center for Clinical Studies
    • Utah
      • Bountiful, Utah, 미국, 84010
        • Cope Family Medicine - Ogden Clinic
      • Springville, Utah, 미국, 84663
        • Springville Dermatology CCT Research
      • West Valley City, Utah, 미국, 84120
        • Kalo Clinical Research
    • Virginia
      • Norfolk, Virginia, 미국, 23502
        • Virginia Dermatology Skin Cancer Center Pllc
  • 브라질
      • Botucatu, 브라질, 18618-686
        • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
      • Brasília, 브라질, 72145-450
        • Chronos Clinica Medica Ltda
      • Ribeirão Preto, 브라질, 14051140
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
      • São José do Rio Preto, 브라질, 15090-000
        • Funfarme Sjrp
      • São Paulo, 브라질, 05403 900
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
      • São Paulo, 브라질, 09060-870
        • Cepes - Fmabc
  • 스페인
      • Alcorcón, 스페인, 28922
        • Hosp. Univ. Fundacion Alcorcon
      • Badalona, 스페인, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, 스페인, 08036
        • Hosp Clinic de Barcelona
      • Manises, 스페인, 46940
        • Hosp. de Manises
      • Salamanca, 스페인, 37007
        • Hosp Clinico Univ de Salamanca
      • Santiago de Compostela, 스페인, 15702
        • Clinica Gaias
      • Santiago de Compostela, 스페인, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, 스페인, 41009
        • Hosp. Virgen Macarena
      • Seville, 스페인, 41014
        • Hosp. Ntra. Sra. de Valme
      • Villajoyosa, 스페인, 03570
        • Hosp. de La Marina Baixa
      • Zaragoza, 스페인, 50009
        • Hosp. Clinico Univ. Lozano Blesa
  • 캐나다
    • British Columbia
      • Surrey, British Columbia, 캐나다, V3R 6A7
        • Dr. Chih ho Hong Medical
    • Manitoba
      • Winnipeg, Manitoba, 캐나다, R3M 3Z4
        • Wiseman Dermatology Research Inc.
    • Ontario
      • London, Ontario, 캐나다, N6A 5R9
        • Lovegrove Dermatology
      • Markham, Ontario, 캐나다, L3P 1X2
        • Lynderm Research Inc.
      • Mississauga, Ontario, 캐나다, L4Y 4C5
        • DermEdge Research
      • Peterborough, Ontario, 캐나다, K9J 5K2
        • SKiN Centre for Dermatology
      • Toronto, Ontario, 캐나다, M3H 5Y8
        • Toronto Research Centre
      • Toronto, Ontario, 캐나다, M2N 3A6
        • North York Research Inc
      • Windsor, Ontario, 캐나다, N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, 캐나다, H2X 2V1
        • Innovaderm Research Inc.
      • Québec, Quebec, 캐나다, G1V 4X7
        • Centre de Recherche Dermatologique du Quebec metropolitain
  • 폴란드
      • Bialystok, 폴란드, 15 797
        • Renew Clinic
      • Katowice, 폴란드, 40 568
        • CaRe Clinic
      • Katowice, 폴란드, 40 611
        • Centrum Medyczne Angelius Provita
      • Kielce, 폴란드, 25-316
        • Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
      • Krakow, 폴란드, 30-002
        • SGD s.c.
      • Krakow, 폴란드, 30-303
        • Krakowskie Centrum Badan Klinicznych
      • Krakow, 폴란드, 30-348
        • Jagiellonskie Centrum Innowacji
      • Krakow, 폴란드, 31 559
        • Diamond Clinic
      • Olsztyn, 폴란드, 10-117
        • Etyka Osrodek Badan Klinicznych
      • Warsaw, 폴란드, 02-962
        • Royalderm Agnieszka Nawrocka
      • Warsaw, 폴란드, 02 661
        • Carpe Diem Centrum Medycyny Estetycznej
      • Warsaw, 폴란드, 02 672
        • Synexus Polska Sp z o o Oddzial w Warszawie
      • Wroclaw, 폴란드, 51 685
        • WroMedica I Bielicka A Strzalkowska s c
  • 헝가리
      • Budapest, 헝가리, 1152
        • Uno Medical Trials Ltd.
      • Gyula, 헝가리, 5700
        • Synexus Magyarorszag Kft
      • Gyöngyös, 헝가리, 3200
        • Bugat Pal Korhaz
      • Kecskemét, 헝가리, 6000
        • Bacs Kiskun Varmegyei Oktatokorhaz
      • Zalaegerszeg, 헝가리, H-8900
        • Synexus Magyarorszag Kft 1
  • 호주
      • Benowa, 호주, 4217
        • The Skin Centre
      • Clayton, 호주, 3168
        • Monash Medical Centre
      • Kogarah, 호주, 2217
        • Premier Specialists
      • Melbourne, 호주, 3004
        • The Alfred Hospital
      • Mitcham, 호주, 3132
        • ISHI dermatology
      • Parkville, 호주, 3050
        • Royal Melbourne Hospital

참여기준

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

자격 기준

자격 기준

임상 연구에 참여하고자 하는 사람들이 충족해야 하는 주요 요구 사항 또는 그들이 가져야 할 특성. 자격 기준은 포함 기준(사람이 연구에 참여하는 데 필요함)과 제외 기준(사람이 참여하지 못하게 하는 것)으로 구성됩니다. 적격성 기준 유형에는 연구가 건강한 지원자를 받아들이는지, 연령 또는 연령 그룹 요구 사항이 있는지 또는 성별에 따라 제한되는지가 포함됩니다.

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 연구 개입의 첫 번째 투여 전 최소 26주 동안 건선성 관절염(PsA) 유무에 관계없이 판상 건선 진단
  • 스크리닝 및 기준시점에서 총 체표면적(BSA)이 (>=)10%(%) 이상
  • 스크리닝 및 기준시점에서 총 건선 부위 및 중증도 지수(PASI) >=12
  • 스크리닝 및 기준선에서 총 조사자 종합 평가(IGA) >=3
  • 판상 건선의 광선요법 또는 전신 치료 후보

제외 기준:

  • 판상이 아닌 형태의 건선(예: 홍피성 건선, 소화성 건선 또는 농포성)
  • 현재 약물 유발 건선(예: 건선의 새로운 발병 또는 베타 차단제, 칼슘 채널 차단제 또는 리튬으로 인한 건선 악화)
  • 중증, 진행성 또는 조절되지 않는 신장, 간, 심장, 혈관, 폐, 위장, 내분비, 신경, 혈액, 류마티스, 정신 또는 대사 장애의 현재 진단 또는 징후 또는 증상
  • JNJ-77242113 또는 그 부형제에 대한 알려진 알레르기, 과민증 또는 불내증
  • 스크리닝 전 8주 이내의 주요 수술(예: 전신 마취가 필요함), 또는 수술 절차에서 완전히 회복되지 않았거나, 참가자가 연구에 참여할 것으로 예상되는 기간 동안 수술 절차가 계획되어 있는 경우

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

참가자 그룹 / 팔

시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.
개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: JNJ-77242113
참가자는 0주차부터 156주차까지 JNJ-77242113을 받고, 0주차부터 24주차까지 듀크라바시티닙 매칭 위약을 받게 됩니다.
의약품: JNJ-77242113
JNJ-77242113은 ​​경구 투여됩니다.
의약품: 듀크라바시티닙 매칭 위약
듀크라바시티닙과 일치하는 위약은 경구 투여됩니다.
위약 비교기: 위약
참가자들은 0주차부터 16주차까지 JNJ-77242113에 대한 매칭 위약을 받고, 0주차부터 24주차까지 듀크라바시티닙에 대한 매칭 위약을, 16주차부터 156주차까지 JNJ-77242113에 대한 위약을 받게 됩니다.
의약품: JNJ-77242113
JNJ-77242113은 ​​경구 투여됩니다.
의약품: JNJ-77242113 매칭 위약
JNJ-77242113 일치하는 위약이 경구 투여됩니다.
의약품: 듀크라바시티닙 매칭 위약
듀크라바시티닙과 일치하는 위약은 경구 투여됩니다.
활성 비교기: 듀크라바시티닙
참가자는 0주차부터 24주차까지 듀크라바시티닙을 투여받고, 0주차부터 24주차까지 JNJ-77242113에 대한 위약, 24주차부터 156주차까지 JNJ-77242113에 상응하는 위약을 투여받게 됩니다.
의약품: JNJ-77242113
JNJ-77242113은 ​​경구 투여됩니다.
의약품: JNJ-77242113 매칭 위약
JNJ-77242113 일치하는 위약이 경구 투여됩니다.
의약품: 듀크라바시티닙
듀크라바시티닙은 경구 투여됩니다.

연구는 무엇을 측정합니까?

주요 결과 측정

주요 결과 측정

임상 연구 프로토콜에서 개입/치료의 효과를 평가하는 데 가장 중요한 계획된 결과 측정. 대부분의 임상 연구에는 하나의 주요 결과 측정이 있지만 일부는 둘 이상입니다.
결과 측정
측정값 설명
기간
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
기간: Week 16
IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using 5 point scale. Induration: 0 =no evidence of plaque elevation, 1=minimal plaque elevation,= 0.25 millimeters (mm); 2=mild plaque elevation,= 0.5 mm; 3=moderate plaque elevation,= 0.75 mm; 4=severe plaque elevation, greater than (>) 1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at the time of first study drug administration date.
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
기간: 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

2차 결과 측정

2차 결과 측정

임상 연구 프로토콜에서 개입의 효과를 평가하기 위한 1차 결과 측정만큼 중요하지는 않지만 여전히 관심이 있는 계획된 결과 측정입니다. 대부분의 임상 연구에는 하나 이상의 2차 결과 측정이 있습니다.
결과 측정
측정값 설명
기간
16주차 기준선 대비 PASI 총점 변화
기간: 기준선(0주차), 16주차
기준선 대비 PASI 총점 변화가 16주차에 보고되었습니다. PASI는 건선 병변의 중증도와 치료에 대한 반응을 평가하고 등급을 매기기 위해 사용된 시스템입니다. PASI 시스템에서는 신체를 4개 부위(머리, 몸통, 상지, 하지)로 나누었습니다. 각 부위는 홍반, 경화, 인설에 대해 별도로 평가 및 점수화되었으며, 각각 0점에서 4점까지(0=없음, 1=경미함, 2=중간, 3=심함, 4=매우 심함) 등급이 매겨졌고, 병변 범위는 0(병변 없음)에서 6(90% - 100% 병변)까지 점수화되었습니다. PASI는 0(건선 없음)부터 72(최대 건선)까지의 숫자 총점을 산출합니다. 점수가 높을수록 건선 중증도가 더 큽니다. 기준선은 첫 연구 약물 투여일 또는 그 이전에 측정된 가장 가까운 측정값으로 정의되었습니다.
기준선(0주차), 16주차
Percentage of Participants Who Achieved PASI 100 Response at Week 16
기간: Week 16
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in Body Surface Area (BSA) at Week 16
기간: Baseline (Week 0), Week 16
A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percent Change From Baseline in PASI Total Score at Week 16
기간: Baseline (Week 0), Week 16
Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved IGA Score of 0 at Week 16
기간: Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Week 16
Percentage of Participants Who Achieved PASI 75 Response at Weeks 4 and 16
기간: Weeks 4 and 16
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 4 and 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 4 and 16
Percentage of Participants Who Achieved PASI 90 Response at Week 8
기간: Week 8
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 8 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 8
Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2
기간: 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
기간: 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
기간: 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
기간: Weeks 16 and 24
IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25mm; 2=mild plaque elevation,=0.5 mm; 3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation,>1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score=more severe disease.Baseline=closest measurement taken prior to or at time of first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved an IGA Score of 0 at Weeks 16 and 24
기간: Weeks 16 and 24
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24
기간: Weeks 16 and 24
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24
기간: Weeks 16 and 24
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 100 Response at Weeks 16 and 24
기간: Weeks 16 and 24
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With a Baseline PSSD Symptom Score >0
기간: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline sPGA-G Score >=2
기간: Week 16
The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Higher score indicates more severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and a >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
기간: Week 16
The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet. hf-PFA was categorized from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher score indicates more severity. Meeting the hf-PGA 0 or 1 criteria defined as having an hf-PGA score of clear (0) or almost clear (1) and a >=2-grade improvement from baseline. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With a Baseline mNAPSI Score >0
기간: Baseline (Week 0), Week 16
Percent change from baseline in mNAPSI score at week 16 was reported. The mNAPSI was an index used for assessing and grading the severity of nail psoriasis. Each of the participant's ten fingernails were evaluated on 7 features. The first three features were each scored from 0 to 3 in severity and were 1=onycholysis and oil-drop dyschromia, 2=pitting, and 3=nail plate crumbling. Next four features was each scored 0 (absent) or 1 (present), and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in lunula. Each fingernail was rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). Total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). Higher the score the more severe the nail bed psoriasis. Baseline=closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With a Baseline f-PGA Score >=2
기간: Week 16
Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. Baseline = closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in PSSD Symptom Score at Week 16
기간: Baseline (Week 0), Week 16
Change from baseline in PSSD symptoms scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Change From Baseline in PSSD Sign Score at Week 16
기간: Baseline (Week 0), Week 16
Change from baseline in PSSD sign scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0
기간: 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
기간: Week 16
The GenPs-SFQ was a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days. Item 1 assesses overall frequency of sexual activity in the last 7 days (none/zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (0 = never, 1 = rarely, 2 = sometimes, 3 = often, or 4 = always). Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Dermatological Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1
기간: Week 16
The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in Total DLQI Score at Week 16
기간: Baseline (Week 0), Week 16
The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Change From Baseline in Domain Scores of the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
기간: Baseline (Week 0), Week 16
PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T-score=more of concept being measured that is higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning. Baseline: closest measurement taken prior to or at time of first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1
기간: Weeks 16 and 24
The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PSSD Symptoms Score of 0 at Week 24 Among Participants With a Baseline PSSD Symptom Score >0
기간: Week 24
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 24
Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24
기간: From Week 24 up to Week 160
From Week 24 up to Week 160
Percentage of Participants Achieving PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24
기간: From Week 24 up to Week 160
From Week 24 up to Week 160
Percentage of Participants Achieving IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24
기간: From Week 24 up to Week 160
From Week 24 up to Week 160
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
기간: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
기간: From Week 0 to Week 160
From Week 0 to Week 160

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

스폰서

연구를 시작하고 연구에 대한 권한과 통제권을 가진 조직 또는 사람.
Janssen Research & Development, LLC

수사관

수사관

임상 연구에 참여하는 연구원. 관련 용어에는 사이트 주임 조사관, 사이트 하위 조사자, 연구 의자, 연구 책임자 및 연구 주임 조사관이 포함됩니다.
  • 연구 책임자: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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)

연구 시작

첫 번째 참가자가 임상 연구에 등록된 실제 날짜입니다. "예상" 연구 시작 날짜는 연구자가 연구 시작 날짜가 될 것이라고 생각하는 날짜입니다.
2024년 3월 9일

기본 완료 (실제)

기본 완료

임상 연구의 마지막 참가자가 1차 결과 측정을 위한 최종 데이터를 수집하기 위해 검사를 받거나 개입을 받은 날짜입니다. 임상 연구가 프로토콜에 따라 종료되었는지 또는 종료되었는지 여부는 이 날짜에 영향을 미치지 않습니다. 완료 날짜가 다른 1차 결과 측정이 둘 이상인 임상 연구의 경우 이 용어는 모든 1차 결과 측정에 대한 데이터 수집이 완료된 날짜를 나타냅니다. "예상" 기본 완료 날짜는 연구원이 연구의 기본 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2024년 11월 15일

연구 완료 (추정된)

연구 완료

임상 연구의 마지막 참가자가 1차 결과 측정, 2차 결과 측정 및 부작용(즉, 마지막 참가자의 마지막 방문)에 대한 최종 데이터를 수집하기 위해 검사를 받거나 중재/치료를 받은 날짜입니다. "예상" 연구 완료 날짜는 연구원이 연구 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2027년 9월 20일

연구 등록 날짜

최초 제출

최초 제출

연구 후원자 또는 연구자가 최초로 ClinicalTrials.gov에 연구 기록을 제출한 날짜. 일반적으로 처음 제출한 날짜와 ClinicalTrials.gov에서 기록을 사용할 수 있는 날짜(첫 게시 날짜) 사이에는 며칠의 지연이 있습니다.
2024년 1월 15일

QC 기준을 충족하는 최초 제출

QC 기준을 충족하는 최초 제출

연구 스폰서 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록을 처음 제출한 날짜입니다. 의뢰자 또는 조사자는 NLM의 QC 검토 기준이 충족되기 전에 연구 기록을 한 번 이상 수정하고 제출해야 할 수 있습니다. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2024년 1월 15일

처음 게시됨 (실제)

처음 게시됨

National Library of Medicine(NLM) 품질 관리(QC) 검토가 완료된 후 ClinicalTrials.gov에서 연구 기록을 처음 사용할 수 있는 날짜입니다. 일반적으로 연구 후원자 또는 연구자가 연구 기록을 제출한 날짜와 처음 게시된 날짜 사이에는 며칠의 지연이 있습니다.
2024년 1월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

마지막 업데이트 게시됨

ClinicalTrials.gov에서 연구 기록이 변경된 가장 최근 날짜. 연구 후원자 또는 연구자가 변경 사항을 ClinicalTrials.gov에 제출한 시점(마지막 업데이트 제출 날짜)과 마지막 업데이트 게시 날짜 사이에 지연이 있을 수 있습니다.
2026년 8월 31일

QC 기준을 충족하는 마지막 업데이트 제출

QC 기준을 충족하는 마지막 업데이트 제출

연구 후원자 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록에 대한 변경 사항을 제출한 가장 최근 날짜. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2026년 8월 27일

마지막으로 확인됨

마지막으로 확인됨

연구 후원자 또는 조사자가 ClinicalTrials.gov에서 임상 연구에 대한 정보가 정확하고 최신 정보라고 확인한 가장 최근 날짜. 모집 상태가 모집인 연구인 경우; 아직 모집하지 않았습니다. 또는 활성, 비모집이 지난 2년 이내에 확인되지 않은 경우 연구의 모집 상태는 알 수 없음으로 표시됩니다.
2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

기타 연구 ID 번호

연구 후원자, 기금 제공자 또는 다른 사람이 임상 연구에 할당한 NCT 번호 이외의 식별자 또는 ID 번호. 이 번호에는 다른 시험 등록의 고유 식별자와 미국 국립보건원(National Institutes of Health) 보조금 번호가 포함될 수 있습니다.
  • 77242113PSO3004 (기타 식별자: Janssen Research & Development, LLC)
  • 2023 (미국 NIH 보조금/계약: GRAMMY Museum Foundation)
  • 2023-507039-39-00 (레지스트리 식별자: EUCT number)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Johnson & Johnson의 Janssen 제약회사의 데이터 공유 정책은 www.janssen.com/clinical-trials/transparency에서 확인할 수 있습니다. 이 사이트에 명시된 바와 같이 연구 데이터에 대한 액세스 요청은 Yale Open Data Access(YODA) 프로젝트 사이트 yoda.yale.edu를 통해 제출할 수 있습니다.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

쿠키 설정

당사는 당사 웹 사이트에서 최상의 경험을 제공하기 위해 쿠키를 사용합니다. 자세한 내용은 개인 정보 보호 및 쿠키 정책 을주의 깊게 읽어보십시오. ...>>>귀하는 정책에 설명 된대로 귀하의 웹 사이트 또는 컴퓨터에서 쿠키를 삭제하여 언제든지 귀하의 기본 설정을 변경하거나 동의를 철회 할 수 있습니다. 동의하고 아래 "설정 관리"섹션에서 해당 상자를 선택하여 기본 설정을 선택하십시오. 이 웹 사이트의 일부를 사용하기 전에 서비스 약관 을주의 깊게 읽어 보시기 바랍니다.
«설정 관리