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중등도 내지 중증 판상 건선 참가자의 치료를 위한 JNJ-77242113에 대한 연구

2026년 7월 2일 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 확인하는 것입니다.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

774

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 대만
      • Hsinchu, 대만, 30059
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City, 대만, 833
        • Chang Kung Memorial Hospital
      • New Taipei City, 대만, 235
        • Taipei Medical University Shuang Ho Hospital
      • Taipei, 대만, 112
        • Taipei Veterans General Hospital
      • Taipei, 대만, 10048
        • National Taiwan University Hospital
      • Taipei, 대만, 10449
        • Taipei Mackay Memorial Hospital
      • Taoyuan, 대만, 33382
        • Linkou Chang Gung Memorial Hospital
  • 대한민국
      • Busan, 대한민국, 49241
        • Pusan National University Hospital
      • Seongnam-si, 대한민국, 13620
        • Seoul National University Bundang Hospital
      • Seoul, 대한민국, 03080
        • Seoul National University Hospital
      • Seoul, 대한민국, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, 대한민국, 05030
        • Konkuk University Medical Center
      • Seoul, 대한민국, 04763
        • Hanyang University Medical Center
      • Seoul, 대한민국, 130 050
        • Kyung Hee University Hospital
  • 독일
      • Berlin, 독일, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Bramsche, 독일, 49565
        • Hautarztpraxis 3
      • Dresden, 독일, 01069
        • Klinische Forschung Dresden GmbH
      • Dresden, 독일, 01097
        • Praxis fuer Dermatologie und Venerologie
      • Düsseldorf, 독일, 40225
        • Universitaetsklinikum Duesseldorf
      • Hamburg, 독일, 22391
        • MensingDerma Research GmbH
      • Hamburg, 독일, 20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Kiel, 독일, 24105
        • Universitaetsklinikum Schleswig Holstein Campus Kiel
      • Langenau, 독일, 89129
        • Studienzentrum Dr Schwarz Germany
      • Leipzig, 독일, 04103
        • Universitätsklinikum Leipzig AöR
      • Lübeck, 독일, 23562
        • Universitatsklinikum Schleswig Holstein Campus Lubeck
      • Mannheim, 독일, 68167
        • Universitaetsklinikum Mannheim
      • München, 독일, 80802
        • Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
      • Potsdam, 독일, 14467
        • Hautarztpraxis 1
      • Rostock, 독일, 18057
        • Universitaetsmedizin Rostock
  • 미국
    • Arizona
      • Phoenix, Arizona, 미국, 85006
        • Medical Dermatology Specialists
      • Scottsdale, Arizona, 미국, 85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fort Smith, Arkansas, 미국, 72916
        • Johnson Dermatology
    • California
      • Fountain Valley, California, 미국, 92708
        • First OC Dermatology
      • Fremont, California, 미국, 94538
        • Center for Dermatology Clinical Research
      • Sacramento, California, 미국, 95815
        • Integrative Skin Science and Research
      • Santa Ana, California, 미국, 92701
        • Southern California Dermatology
      • Santa Monica, California, 미국, 90403
        • Clinical Science Institute
    • Florida
      • Miami, Florida, 미국, 33126
        • Driven Research LLC
      • North Miami Beach, Florida, 미국, 33162
        • Ziaderm Research LLC
      • Ocala, Florida, 미국, 34470
        • Renstar Medical Research
      • Tampa, Florida, 미국, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Alpharetta, Georgia, 미국, 30022
        • Hamilton Research LLC
      • Macon, Georgia, 미국, 31217
        • Skin Care Physicians Of Georgia
    • Illinois
      • Chicago, Illinois, 미국, 60602
        • DeNova Research
      • Rolling Meadows, Illinois, 미국, 60008
        • Arlington Dermatology
      • Skokie, Illinois, 미국, 60077
        • Endeavor Health
      • West Dundee, Illinois, 미국, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, 미국, 46250
        • Dawes Fretzin Clinical Research Group LLC
      • Plainfield, Indiana, 미국, 46168
        • Indiana Clinical Trial Center
    • Kentucky
      • Louisville, Kentucky, 미국, 40241
        • Dermatology Specialists
    • Louisiana
      • Lake Charles, Louisiana, 미국, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Boston, Massachusetts, 미국, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, 미국, 48103
        • David Fivenson MD, Dermatology
      • Clarkston, Michigan, 미국, 48346
        • Michigan Center of Medical Research
      • Detroit, Michigan, 미국, 48202
        • Henry Ford Medical Center
      • Fort Gratiot, Michigan, 미국, 48059
        • Hamzavi Dermatology
    • Missouri
      • Saint Joseph, Missouri, 미국, 64506
        • MediSearch Clinical Trials
    • Nebraska
      • Omaha, Nebraska, 미국, 68144
        • Skin Specialists
    • Nevada
      • Las Vegas, Nevada, 미국, 89119
        • Fife Dermatology
    • New Hampshire
      • Portsmouth, New Hampshire, 미국, 03801
        • StracSkin
    • New Jersey
      • East Windsor, New Jersey, 미국, 08520
        • Schweiger Dermatology Group
      • Hackensack, New Jersey, 미국, 07601
        • Schweiger Dermatology Group 1
    • New York
      • Stony Brook, New York, 미국, 11790
        • Derm Research Center of New York, Inc.
    • North Carolina
      • Wilmington, North Carolina, 미국, 28405
        • Wilmington Dermatology Center
    • Ohio
      • Athens, Ohio, 미국, 45701
        • Oakview Dermatology
      • Boardman, Ohio, 미국, 44512
        • Optima Research
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73170
        • Central Sooner Research
    • Oregon
      • Portland, Oregon, 미국, 97201
        • Oregon Medical Research Center
    • South Dakota
      • Rapid City, South Dakota, 미국, 57702
        • Health Concepts
    • Texas
      • Dallas, Texas, 미국, 75231
        • Modern Research Associates
      • Houston, Texas, 미국, 77004
        • Center for Clinical Studies 1
      • Houston, Texas, 미국, 77056
        • Austin Institute for Clinical Research 1
      • Pflugerville, Texas, 미국, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, 미국, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, 미국, 78213
        • Progressive Clinical Research
      • Webster, Texas, 미국, 77598
        • Center for Clinical Studies
    • Virginia
      • Richmond, Virginia, 미국, 23294
        • National Clinical Research
    • Washington
      • Mill Creek, Washington, 미국, 98012
        • Frontier Derm Partners CRO, LLC
      • Spokane, Washington, 미국, 99202
        • Premier Clinical Research
  • 브라질
      • Santo André, 브라질, 09060-870
        • Fundacao do ABC Centro Universitario FMABC
  • 스페인
      • Alicante, 스페인, 03010
        • Hosp. Gral. Univ. Dr. Balmis
      • Barakaldo, 스페인, 48902
        • Hosp. Univ. de Cruces
      • Barcelona, 스페인, 08041
        • Hosp. de La Santa Creu I Sant Pau
      • Granada, 스페인, 18016
        • Hosp. Univ. San Cecilio
      • L'Hospitalet de Llobregat, 스페인, 08907
        • Hosp. Univ. de Bellvitge
      • Madrid, 스페인, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, 스페인, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, 스페인, 28031
        • Hosp. Univ. Infanta Leonor
      • Madrid, 스페인, 28006
        • Hosp. Univ. de La Princesa
      • Madrid, 스페인, 28046
        • Hosp. Univ. de La Paz
      • Madrid, 스페인, 28002
        • Grupo Dermatologico Y Estetico Pedro Jaen
      • Valencia, 스페인, 46026
        • Hosp. Univ. I Politecni La Fe
  • 아르헨티나
      • Buenos Aires, 아르헨티나, B1643CRO
        • Instituto Medico De Alta Complejidad (IMAC)
      • Buenos Aires, 아르헨티나, C1406AGA
        • ARCIS Salud SRL Aprillus asistencia e investigacion
      • CABA, 아르헨티나, C1425BEA
        • Instituto de Neumonología Y Dermatología
      • Caba, 아르헨티나, C1199ABD
        • Hospital Italiano de Buenos Aires
      • Caba, 아르헨티나, C1122AAF
        • Halitus Instituto Medico S.A. - Dermatologia y Estetica
      • La Plata, 아르헨티나, B1900AXI
        • Hospital Italiano de La Plata
      • Rosario, 아르헨티나, S2000PBJ
        • Instituto Caici Srl.
      • San Miguel de Tucumán, 아르헨티나, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
  • 영국
      • London, 영국, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Reading, 영국, RG1 5AN
        • Royal Berkshire Hospital
      • Salford, 영국, M6 8HD
        • Salford Royal Hospital
      • Southampton, 영국, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • 일본
      • Fukuoka, 일본, 814-0180
        • Fukuoka University Hospital
      • Fukutsu, 일본, 811-3217
        • Hino Dermatology Clinic
      • Gifu, 일본, 501-1112
        • Gifu University Hospital
      • Ginowan, 일본, 901 2725
        • University of the Ryukyus hospital
      • Gunma, 일본, 371 8511
        • Gunma University Hospital
      • Hokkaido, 일본, 060-0033
        • JR Sapporo Hospital
      • Hokkaido, 일본, 078 8510
        • Asahikawa Medical University Hospital
      • Isehara, 일본, 259-1193
        • Tokai University Hospital
      • Itabashi Ku, 일본, 173 8606
        • Teikyo University Hospital
      • Kawasaki, 일본, 216 8511
        • St Marianna University Hospital
      • Kitakyushu-shi, 일본, 807-8556
        • Hospital of the University of Occupational and Environmental Health
      • Nagoya, 일본, 467 8602
        • Nagoya City University Hospital
      • Nishiku, 일본, 593-8324
        • Kume Clinic
      • Obihiro Shi, 일본, 080 0013
        • Takagi Dermatological Clinic
      • Osaka, 일본, 550 0006
        • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
      • Sakai, 일본, 590 0197
        • Kindai University Hospital
      • Sapporo, 일본, 060 0063
        • Sapporo Skin Clinic
      • Sendai, 일본, 980 8574
        • Tohoku University Hospital
      • Suita, 일본, 565 0871
        • The University of Osaka Hospital
      • Tachikawa, 일본, 190 0023
        • Jitaikai Tachikawa dermatology clinic
      • Takaoka Shi, 일본, 933-0871
        • Shirasaki dermatology clinic
      • Tokyo, 일본, 160-0023
        • Tokyo Medical University Hospital
      • Tsu, 일본, 514 8507
        • Mie University Hospital
  • 캐나다
    • British Columbia
      • Surrey, British Columbia, 캐나다, V3V 0C6
        • Enverus Medical
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, 캐나다, A1A 4Y3
        • Karma Clinical Trials Inc.
    • Ontario
      • Ajax, Ontario, 캐나다, L1S7K8
        • CCA Medical Research Corporation
      • Barrie, Ontario, 캐나다, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre
      • Hamilton, Ontario, 캐나다, L8N 1Y2
        • Dermatrials Research
      • Richmond Hill, Ontario, 캐나다, L4B1L1
        • York Dermatology Clinic and Research Centre
      • Waterloo, Ontario, 캐나다, N2J 1C4
        • Alliance Clinical Trials
      • Windsor, Ontario, 캐나다, N8T 1E6
        • XLR8 Medical Research
  • 폴란드
      • Bialystok, 폴란드, 15-351
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok, 폴란드, 15-375
        • Specderm Poznanska sp j
      • Elblag, 폴란드, 82 300
        • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
      • Krakow, 폴란드, 31-411
        • Centrum Medyczne PROMED
      • Krakow, 폴란드, 30 438
        • Centrum Medyczne dr Rajzer Sp z o o
      • Krakow, 폴란드, 30-002
        • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
      • Lodz, 폴란드, 90-338
        • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
      • Lodz, 폴란드, 90-265
        • Dermed Centrum Medyczne Sp z o o
      • Osielsko, 폴란드, 86031
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
      • Poznan, 폴란드, 61 731
        • Clinical Research Center sp z o o MEDIC R s k
      • Poznan, 폴란드, 60 529
        • SOLUMED Centrum Medyczne
      • Warsaw, 폴란드, 02 953
        • Klinika Ambroziak Dermatologia
      • Warsaw, 폴란드, 01 817
        • Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
      • Wroclaw, 폴란드, 51 503
        • DERMMEDICA Sp.z o.o.
      • Wroclaw, 폴란드, 52 416
        • Centrum Medyczne Oporow
      • Wroclaw, 폴란드, 51 685
        • Wro Medica
  • 헝가리
      • Borgyogyaszati Klinika, 헝가리, 7632
        • Pecsi Tudomanyegyetem
      • Budapest, 헝가리, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Debrecen, 헝가리, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, 헝가리, 4031
        • Derma-B Kft
      • Kaposvár, 헝가리, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
      • Szeged, 헝가리, 6720
        • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
      • Szolnok, 헝가리, 5000
        • Allergo-Derm Bakos Kft.
      • Veszprém, 헝가리, 8200
        • Medmare Egeszsegugyi Es Szolgaltato Bt.
  • 호주
      • Campbelltown, 호주, 5074
        • North Eastern Health Specialists
      • Canberra, 호주, 2606
        • Paratus Clinical Research Woden
      • East Melbourne, 호주, 3002
        • Sinclair Dermatology
      • Melbourne, 호주, 3053
        • Skin Health Institute Inc.
      • Woolloongabba, 호주, 4102
        • Veracity Clinical Research

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

  • 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
개입 / 치료
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

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

결과 측정
측정값 설명
기간
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
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 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 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 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
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 PASI 75 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 was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 4 and 16
Percentage of Participants Who Achieved PASI 90 at Week 8
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 was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 8
Percentage of Participants Who Achieved PASI 100 at Week 16
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
Percentage of Participants Who Achieved a Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2
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 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 a 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation, =0.25 mm; 2=mild plaque elevation, =0.5 mm; 3=moderate plaque elevation, =0.75 mm; 4=severe plaque elevation, >1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over <5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 75 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 was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 90 at Weeks 16 and 24
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 was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 100 at Weeks 16 and 24
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 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
Change From Baseline in PASI Total Score at Week 16
기간: Baseline (Week 0), Week 16
Change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percent Change From Baseline in PASI Total Score at Week 16
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 was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-grade Improvement at Week 16 Among Participants With a Baseline sPGA-G Score >=2
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 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 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. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in PSSD Symptom Score at Week 16
기간: Baseline (Week 0), Week 16
Change from baseline in PSSD symptoms score at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date
Baseline (Week 0), Week 16
Change From Baseline in PSSD Sign Score at Week 16
기간: Baseline (Week 0), Week 16
Change from baseline in PSSD sign score at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Change From Baseline in Total DLQI Score at Week 16
기간: Baseline (Week 0), Week 16
Change from baseline in total DLQI score at Week 16 was reported. The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
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 i.e. higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 24 Among Participants With Baseline 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: Week 24 up to Week 160
Week 24 up to Week 160
Percentage of Participants Who Achieved PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24
기간: Week 24 up to Week 160
Week 24 up to Week 160
Percentage of Participants Who Achieved IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24
기간: Week 24 up to Week 160
Week 24 up to Week 160
Number of Participants With Adverse Events (AEs)
기간: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Serious Adverse Events (SAEs)
기간: From Week 0 to Week 160
From Week 0 to Week 160

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Janssen Research & Development, LLC

수사관

  • 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)

2024년 2월 1일

기본 완료 (실제)

2024년 9월 17일

연구 완료 (추정된)

2027년 6월 1일

연구 등록 날짜

최초 제출

2023년 11월 14일

QC 기준을 충족하는 최초 제출

2023년 11월 16일

처음 게시됨 (실제)

2023년 11월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 2일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 77242113PSO3002 (기타 식별자: Janssen Research & Development, LLC)

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. .

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