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특수 부위(두피, 생식기 및/또는 손바닥 및 발바닥)와 관련된 판상 건선 참가자의 치료를 위한 JNJ-77242113에 대한 연구 (ICONIC-TOTAL)

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

특수 부위와 관련된 판상 건선 참가자의 치료를 위한 JNJ-77242113의 효능과 안전성을 평가하기 위한 3상 다기관, 무작위, 이중 맹검, 위약 대조 연구

연구의 목적은 JNJ-77242113이 특수 부위(두피, 생식기 및/또는 손바닥과 발바닥)에 영향을 미치는 판상 건선이 있는 참가자에게 얼마나 효과적인지 확인하는 것입니다.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

311

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, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, 대만, 10048
        • National Taiwan University 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, 08308
        • Korea University Guro Hospital
      • Seoul, 대한민국, 05030
        • Konkuk University Medical Center
  • 독일
      • Berlin, 독일, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Berlin, 독일, 13627
        • CRS Clinical Research Services Berlin GMBH
      • Bochum, 독일, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, 독일, 64283
        • Rosenpark Research GmbH
      • Dresden, 독일, 01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Frankfurt am Main, 독일, 60590
        • Universitaetsklinikum Frankfurt
      • Hamburg, 독일, 20354
        • Dermatologikum Hamburg Gmbh
      • Schwerin, 독일, 19055
        • Klinische Forschung Schwerin GmbH
      • Witten, 독일, 58453
        • Hautarztpraxis 2
  • 미국
    • Arizona
      • Scottsdale, Arizona, 미국, 85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fort Smith, Arkansas, 미국, 72916
        • Johnson Dermatology
    • California
      • Encinitas, California, 미국, 92024
        • California Dermatology & Clinical Research Institute
    • Florida
      • Tampa, Florida, 미국, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Alpharetta, Georgia, 미국, 30022
        • Hamilton Research LLC
    • Illinois
      • Rolling Meadows, Illinois, 미국, 60008
        • Arlington Dermatology
      • 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
    • Louisiana
      • Lake Charles, Louisiana, 미국, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Beverly, Massachusetts, 미국, 01915
        • Allcutis Research 1
    • Michigan
      • Fort Gratiot, Michigan, 미국, 48059
        • Hamzavi Dermatology
    • Minnesota
      • New Brighton, Minnesota, 미국, 55112
        • Minnesota Clinical Study Center
    • Missouri
      • Saint Joseph, Missouri, 미국, 64506
        • MediSearch Clinical Trials
    • Nebraska
      • Omaha, Nebraska, 미국, 68144
        • Skin Specialists
    • New Jersey
      • East Windsor, New Jersey, 미국, 08520
        • Schweiger Dermatology Group
    • Ohio
      • Boardman, Ohio, 미국, 44512
        • Optima Research
    • Oregon
      • Portland, Oregon, 미국, 97210
        • Oregon Dermatology and Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19103
        • Paddington Testing Co, Inc.
      • Pittsburgh, Pennsylvania, 미국, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Arlington, Texas, 미국, 76011
        • Arlington Research Center, inc.
      • Houston, Texas, 미국, 77004
        • Center for Clinical Studies 1
      • Pflugerville, Texas, 미국, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, 미국, 78229
        • Dermatology Clinical Research Center of San Antonio
      • San Antonio, Texas, 미국, 78213
        • Progressive Clinical Research
      • Webster, Texas, 미국, 77598
        • Center for Clinical Studies
    • Utah
      • Bountiful, Utah, 미국, 84010
        • Cope Family Medicine - Ogden Clinic
    • Washington
      • Mill Creek, Washington, 미국, 98012
        • Frontier Derm Partners CRO, LLC
  • 스페인
      • Badalona, 스페인, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, 스페인, 08003
        • Hosp. Del Mar
      • Esplugues de Llobregat, 스페인, 08950
        • Hosp. Sant Joan de Deu
      • Granada, 스페인, 18016
        • Hosp. Univ. San Cecilio
      • Madrid, 스페인, 28041
        • Hosp. Univ. 12 de Octubre
      • Manises, 스페인, 46940
        • Hosp. de Manises
      • Seville, 스페인, 41009
        • Hosp. Virgen Macarena
      • Valencia, 스페인, 46026
        • Hosp. Univ. I Politecni La Fe
  • 아르헨티나
      • Buenos Aires, 아르헨티나, C1417EYG
        • Centro Privado de Medicina Familiar
      • Buenos Aires, 아르헨티나, C1061AAS
        • CIPREC
      • CABA, 아르헨티나, C1012AAY
        • CONEXA Investigacion Clinica S.A.
      • Caba, 아르헨티나, C1060ABN
        • CEDIC Centro de Investigación Clínica
  • 영국
      • Harrow, 영국, HA1 3UJ
        • London North West University Healthcare NHS Trust
      • Salford, 영국, M6 8HD
        • Salford Royal Hospital
      • Southampton, 영국, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • 캐나다
    • Alberta
      • Edmonton, Alberta, 캐나다, T6G 1C3
        • Alberta Dermasurgery Centre
    • Ontario
      • Markham, Ontario, 캐나다, L3P 1X3
        • Lynderm Research Inc.
      • Peterborough, Ontario, 캐나다, K9J 5K2
        • SKiN Centre for Dermatology
      • Richmond Hill, Ontario, 캐나다, L4B1L1
        • York Dermatology Clinic and Research Centre
    • Quebec
      • Montreal, Quebec, 캐나다, H2X 2V1
        • Innovaderm Research Inc.
      • Québec, Quebec, 캐나다, G1V 4X7
        • Centre Dermatologique
    • Saskatchewan
      • Saskatoon, Saskatchewan, 캐나다, S7K 2C1
        • Skinsense Medical Research
  • 터키 (Türkiye)
      • Konya, 터키 (Türkiye), 42080
        • Necmettin Erbakan University Meram Medical Faculty
      • Samsun, 터키 (Türkiye), 55270
        • Ondokuz Mayis University
      • Trabzon, 터키 (Türkiye), 61080
        • Karadeniz Teknik University Medical Faculty
  • 폴란드
      • Bialystok, 폴란드, 15-351
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok, 폴란드, 15-375
        • Specderm Poznanska sp j
      • 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, 90-265
        • 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, 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, 4031
        • Derma-B Kft
      • 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.

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

  • 어린이
  • 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
  • 판상 건선의 광선요법 또는 전신 치료 후보
  • 기준을 충족해야 함: 스크리닝 및 기준시점에서 총 체표면적(BSA)이 (>=)1%(%) 이상, 조사자 종합 평가(IGA)(전체) >=2 스크리닝 및 기준시점 및 기준시점에서 다음 중 적어도 하나: 스크리닝 및 기준시점에서 두피 특이적 조사자 종합 평가(ss-IGA) 점수 >=3, 및/또는 스크리닝 및 기준시점에서 정적 의사의 생식기에 대한 종합 평가(sPGA-G) >=3, 및/또는 또는 스크리닝 및 기준시점에서 의사의 손발 종합 평가(hf-PGA) 점수 >=3
  • 건선 치료에 사용되는 최소 1가지 국소 요법(예: 코르티코스테로이드, 칼시뉴린 억제제 및/또는 비타민 D 유사체)에 반응하지 않음
  • 스크리닝 및 기준시점에서 비특이 부위(예: 두피, 생식기, 손발바닥을 제외한 부위)에서 판상 건선 확인

제외 기준:

  • 판상이 아닌 형태의 건선(예: 홍피성 건선, 소화성 건선 또는 농포성 건선)
  • 판상 건선(예: 접촉성 피부염) 또는 손발바닥 부위의 손발바닥 농포증(기준시점에서 hf-PGA >=3인 경우) 이외의 피부병
  • 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

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 받게 됩니다.
의약품: JNJ-77242113
JNJ-77242113은 ​​경구 투여됩니다.
위약 비교기: 위약
참가자는 0주차부터 16주차까지 위약을 투여받고, 그 이후 16주차부터 156주차까지 JNJ-77242113을 투여받게 됩니다.
의약품: 위약
위약은 구두로 투여됩니다.
의약품: JNJ-77242113
JNJ-77242113은 ​​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

2차 결과 측정

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
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 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
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
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 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
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
Percentage of Participants Who Achieved a Scalp Specific (ss)-IGA Score of 0 or 1 at Week 16 Among Participants With a Baseline Ss-IGA Score >=3
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 Scalp Severity Index (PSSI) 90 at Week 16 Among Participants With a Baseline Ss-IGA Score >=3
기간: Week 16
PSSI 90 response is defined as a percentage of participants who achieved at least 90% improvement from baseline in the PSSI score. PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). Higher scores indicating more severe symptoms. Baseline=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 at Week 16 Among Participants With a Baseline sPGA Score >=3
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 at Week 16 Among Participants With a Baseline Hf-PGA Score >=3
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) among participants. 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 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 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 >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a Baseline PSSD Itch Score >=4
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 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.
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 sPGA-G Score >=3 and a Baseline GenPs-SFQ Item 2 Score >=2
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). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date. Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis.
Week 16
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 16 Among Participants With a Baseline Ss-IGA Score >=3 and a Baseline Scalp Itch NRS Score >=4
기간: Week 16
The Scalp Itch NRS is a single item instrument that evaluates the severity of scalp itch in adult and adolescent populations over the past 24 hours. The instrument uses an NRS score ranging from 0 (no scalp itch) to 10 (worst scalp itch imaginable), with higher scores indicative of greater symptom 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 >=4-Point Improvement From Baseline in Genital Psoriasis Symptoms Score (GPSS) Genital Itch NRS Score at Week 16 Among Participants With a Baseline sPGA-G Score >=3 and a Baseline GPSS Genital Itch NRS Score >=4
기간: Week 16
The GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent is asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an NRS of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, ranging from 0 (no severity) to 10 (worst imaginable severity). Higher scores indicate greater itch intensity. 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 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 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 16
Percentage of Participants Who Achieved PASI 75 at Week 16
기간: Week 16
Percentage of participants who achieved PASI-75 score (>=75% 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 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 16
Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (fPGA) 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. 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 PSSD Symptoms Score of 0 at Week 8 Among Participants With a Baseline PSSD Symptom Score >0
기간: Week 8
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 8
Change From Baseline in PSSD Symptoms 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
Percentage of Participants Achieving >=4-Point Improvement From Baseline in PSSD Itch Score at Week 4 Among Participants With a Baseline Itch Score >=4
기간: Week 4
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.
Week 4
Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline PSSD 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 Children's Dermatological Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 Among Adolescent Participants With a Baseline CDLQI Score >1
기간: Week 16
The CDLQI was an adapted version of the DLQI for the pediatric population and was utilized in the adolescent population in this study. The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. The instrument is designed for use in children, is self-explanatory and can be simply handed to the participant who asked to fill it in with the help of the child's parent or caregiver. 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 Domain Scores of the PROMIS-25 Pediatric Score at Week 16
기간: Baseline (Week 0), Week 16
The PROMIS-25 was utilized in the adolescent population and is a 25-item generic HRQoL survey. Six PROMIS domains (physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference) are each assessed with 4 questions. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Higher score=worst pain. Raw scores for each domain were converted to T-scores using standardized score with a mean of 50 and a standard deviation (SD) of 10 with an observed range 20 to 80. For anxiety, depressive symptoms, fatigue, and pain interference, a negative change indicates an improvement while for physical function mobility and peer relationships, a positive change indicates an improvement. 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 Palmoplantar Quality of Life Instrument (ppQLI) Hands Score at Week 16 Among Participants With a Baseline Hf-PGA Score >=3
기간: Baseline (Week 0), Week 16
The ppQLI assesses impact on patient quality of life due to palmoplantar psoriasis over the past month in adult and adolescent populations. Sixteen items evaluate hand functionality, pain, and social impact due to psoriasis. Fourteen items evaluate foot functionality, pain, and physical limitations due to psoriasis. All items use verbal rating scales ranging from 1 to 5. The ppQLI yields a score for hands, ranging from 16 to 80, and a score for feet, ranging from 14 to 70. Higher score indicating 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.
Baseline (Week 0), Week 16
Change From Baseline in ppQLI Feet Score at Week 16 Among Participants With a Baseline Hf-PGA Score >=3
기간: Baseline (Week 0), Week 16
The ppQLI assesses impact on patient quality of life due to palmoplantar psoriasis over the past month in adult and adolescent populations. Sixteen items evaluate hand functionality, pain, and social impact due to psoriasis. Fourteen items evaluate foot functionality, pain, and physical limitations due to psoriasis. All items use verbal rating scales ranging from 1 to 5. The ppQLI yields a score for hands, ranging from 16 to 80, and a score for feet, ranging from 14 to 70. Higher score indicating 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.
Baseline (Week 0), Week 16
Change From Baseline in Genital Psoriasis Symptoms Score (GPSS) Total Score at Week 16 Among Participants With a Baseline sPGA-G Score >=3
기간: Baseline (Week 0), Week 16
The GPSS was a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom was indicated by selecting the number from an NRS of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, ranging from 0 (no severity) to 10 (worst imaginable severity). Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms). A negative change from baseline indicates an improvement in genital psoriasis symptoms. 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

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