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Studie JNJ-77242113 pro léčbu účastníků s plakovou psoriázou zahrnující speciální oblasti (skalp, genitálie a/nebo dlaně a plosky nohou) (ICONIC-TOTAL)

27. srpna 2026 aktualizováno: Janssen Research & Development, LLC

Multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie fáze 3 k vyhodnocení účinnosti a bezpečnosti JNJ-77242113 pro léčbu účastníků s plakovou psoriázou zahrnující speciální oblasti

Účelem studie je zjistit, jak účinný je JNJ-77242113 u účastníků s plakovou psoriázou postihující speciální oblasti (skalp, genitálie a/nebo dlaně a plosky nohou).

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

311

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Argentina
      • Buenos Aires, Argentina, C1417EYG
        • Centro Privado de Medicina Familiar
      • Buenos Aires, Argentina, C1061AAS
        • CIPREC
      • CABA, Argentina, C1012AAY
        • CONEXA Investigacion Clinica S.A.
      • Caba, Argentina, C1060ABN
        • CEDIC Centro de Investigación Clínica
  • Jižní Korea
      • Busan, Jižní Korea, 49241
        • Pusan National University Hospital
      • Seongnam-si, Jižní Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Jižní Korea, 03080
        • Seoul National University Hospital
      • Seoul, Jižní Korea, 08308
        • Korea University Guro Hospital
      • Seoul, Jižní Korea, 05030
        • Konkuk University Medical Center
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1C3
        • Alberta Dermasurgery Centre
    • Ontario
      • Markham, Ontario, Kanada, L3P 1X3
        • Lynderm Research Inc.
      • Peterborough, Ontario, Kanada, K9J 5K2
        • SKiN Centre for Dermatology
      • Richmond Hill, Ontario, Kanada, L4B1L1
        • York Dermatology Clinic and Research Centre
    • Quebec
      • Montreal, Quebec, Kanada, H2X 2V1
        • Innovaderm Research Inc.
      • Québec, Quebec, Kanada, G1V 4X7
        • Centre Dermatologique
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7K 2C1
        • Skinsense Medical Research
  • Maďarsko
      • Borgyogyaszati Klinika, Maďarsko, 7632
        • Pecsi Tudomanyegyetem
      • Budapest, Maďarsko, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Debrecen, Maďarsko, 4031
        • Derma-B Kft
      • Szeged, Maďarsko, 6720
        • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
      • Szolnok, Maďarsko, 5000
        • Allergo-Derm Bakos Kft.
      • Veszprém, Maďarsko, 8200
        • Medmare Egeszsegugyi Es Szolgaltato Bt.
  • Německo
      • Berlin, Německo, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Berlin, Německo, 13627
        • CRS Clinical Research Services Berlin GMBH
      • Bochum, Německo, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, Německo, 64283
        • Rosenpark Research GmbH
      • Dresden, Německo, 01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Frankfurt am Main, Německo, 60590
        • Universitaetsklinikum Frankfurt
      • Hamburg, Německo, 20354
        • Dermatologikum Hamburg Gmbh
      • Schwerin, Německo, 19055
        • Klinische Forschung Schwerin GmbH
      • Witten, Německo, 58453
        • Hautarztpraxis 2
  • Polsko
      • Bialystok, Polsko, 15-351
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok, Polsko, 15-375
        • Specderm Poznanska sp j
      • Krakow, Polsko, 31-411
        • Centrum Medyczne PROMED
      • Krakow, Polsko, 30 438
        • Centrum Medyczne dr Rajzer Sp z o o
      • Krakow, Polsko, 30-002
        • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
      • Lodz, Polsko, 90-265
        • Dermed Centrum Medyczne Sp z o o
      • Osielsko, Polsko, 86031
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
      • Poznan, Polsko, 61 731
        • Clinical Research Center sp z o o MEDIC R s k
      • Poznan, Polsko, 60 529
        • SOLUMED Centrum Medyczne
      • Warsaw, Polsko, 02 953
        • Klinika Ambroziak Dermatologia
      • Warsaw, Polsko, 01 817
        • Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
      • Wroclaw, Polsko, 52 416
        • Centrum Medyczne Oporow
      • Wroclaw, Polsko, 51 685
        • Wro Medica
  • Spojené království
      • Harrow, Spojené království, HA1 3UJ
        • London North West University Healthcare NHS Trust
      • Salford, Spojené království, M6 8HD
        • Salford Royal Hospital
      • Southampton, Spojené království, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • Spojené státy
    • Arizona
      • Scottsdale, Arizona, Spojené státy, 85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fort Smith, Arkansas, Spojené státy, 72916
        • Johnson Dermatology
    • California
      • Encinitas, California, Spojené státy, 92024
        • California Dermatology & Clinical Research Institute
    • Florida
      • Tampa, Florida, Spojené státy, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Alpharetta, Georgia, Spojené státy, 30022
        • Hamilton Research LLC
    • Illinois
      • Rolling Meadows, Illinois, Spojené státy, 60008
        • Arlington Dermatology
      • West Dundee, Illinois, Spojené státy, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, Spojené státy, 46250
        • Dawes Fretzin Clinical Research Group LLC
      • Plainfield, Indiana, Spojené státy, 46168
        • Indiana Clinical Trial Center
    • Louisiana
      • Lake Charles, Louisiana, Spojené státy, 70605
        • Dermatology and Advanced Aesthetics
    • Massachusetts
      • Beverly, Massachusetts, Spojené státy, 01915
        • Allcutis Research 1
    • Michigan
      • Fort Gratiot, Michigan, Spojené státy, 48059
        • Hamzavi Dermatology
    • Minnesota
      • New Brighton, Minnesota, Spojené státy, 55112
        • Minnesota Clinical Study Center
    • Missouri
      • Saint Joseph, Missouri, Spojené státy, 64506
        • MediSearch Clinical Trials
    • Nebraska
      • Omaha, Nebraska, Spojené státy, 68144
        • Skin Specialists
    • New Jersey
      • East Windsor, New Jersey, Spojené státy, 08520
        • Schweiger Dermatology Group
    • Ohio
      • Boardman, Ohio, Spojené státy, 44512
        • Optima Research
    • Oregon
      • Portland, Oregon, Spojené státy, 97210
        • Oregon Dermatology and Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy, 19103
        • Paddington Testing Co, Inc.
      • Pittsburgh, Pennsylvania, Spojené státy, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Arlington, Texas, Spojené státy, 76011
        • Arlington Research Center, inc.
      • Houston, Texas, Spojené státy, 77004
        • Center for Clinical Studies 1
      • Pflugerville, Texas, Spojené státy, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, Spojené státy, 78229
        • Dermatology Clinical Research Center of San Antonio
      • San Antonio, Texas, Spojené státy, 78213
        • Progressive Clinical Research
      • Webster, Texas, Spojené státy, 77598
        • Center for Clinical Studies
    • Utah
      • Bountiful, Utah, Spojené státy, 84010
        • Cope Family Medicine - Ogden Clinic
    • Washington
      • Mill Creek, Washington, Spojené státy, 98012
        • Frontier Derm Partners CRO, LLC
  • Tchaj-wan
      • Hsinchu, Tchaj-wan, 30059
        • National Taiwan University Hospital Hsin Chu Branch
      • Kaohsiung City, Tchaj-wan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Tchaj-wan, 10048
        • National Taiwan University Hospital
      • Taoyuan, Tchaj-wan, 33382
        • Linkou Chang Gung Memorial Hospital
  • Turecko (Türkiye)
      • Konya, Turecko (Türkiye), 42080
        • Necmettin Erbakan University Meram Medical Faculty
      • Samsun, Turecko (Türkiye), 55270
        • Ondokuz Mayis University
      • Trabzon, Turecko (Türkiye), 61080
        • Karadeniz Teknik University Medical Faculty
  • Španělsko
      • Badalona, Španělsko, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Španělsko, 08003
        • Hosp. Del Mar
      • Esplugues de Llobregat, Španělsko, 08950
        • Hosp. Sant Joan de Deu
      • Granada, Španělsko, 18016
        • Hosp. Univ. San Cecilio
      • Madrid, Španělsko, 28041
        • Hosp. Univ. 12 de Octubre
      • Manises, Španělsko, 46940
        • Hosp. de Manises
      • Seville, Španělsko, 41009
        • Hosp. Virgen Macarena
      • Valencia, Španělsko, 46026
        • Hosp. Univ. I Politecni La Fe

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

  • Diagnostika plakové psoriázy, s psoriatickou artritidou (PsA) nebo bez ní, po dobu alespoň 26 týdnů před prvním podáním studijní intervence
  • Kandidát na fototerapii nebo systémovou léčbu ložiskové psoriázy
  • Potřeba splnit kritéria: Celková plocha povrchu těla (BSA) větší nebo rovna (>=) 1 procentu (%) při screeningu a výchozí hodnotě a celkové hodnocení zkoušejícího (IGA) (celkově) >=2 při screeningu a výchozí hodnotě a při alespoň jedno z následujících: skóre globálního hodnocení zkoušejícího specifického pro pokožku hlavy (ss-IGA) >=3 při screeningu a na začátku a/nebo celkové hodnocení genitálií statickým lékařem (sPGA-G) >=3 při screeningu a na začátku, a/ nebo celkové hodnocení rukou a nohou (hf-PGA) lékařem >=3 při screeningu a výchozí hodnotě
  • Selhala odpověď na alespoň 1 topickou terapii (příklad, kortikosteroidy, inhibitory kalcineurinu a/nebo analogy vitaminu D) používanou k léčbě psoriázy
  • Potvrzení plakové psoriázy v nespeciální oblasti (příklad, oblasti kromě pokožky hlavy, genitálie, palmoplantární) při screeningu a výchozím stavu

Kritéria vyloučení:

  • Neplaková forma psoriázy (příklad, erytrodermická, guttální nebo pustulózní)
  • Jiné dermatózy než plaková psoriáza (jako je kontaktní dermatitida) nebo palmoplantární pustulóza palmoplantární oblasti (pokud hf-PGA >=3 na začátku)
  • Současná psoriáza vyvolaná léky (příklad, nový nástup psoriázy nebo exacerbace psoriázy z betablokátorů, blokátorů kalciových kanálů nebo lithia)
  • Současná diagnóza nebo známky nebo příznaky závažných, progresivních nebo nekontrolovaných renálních, jaterních, srdečních, cévních, plicních, gastrointestinálních, endokrinních, neurologických, hematologických, revmatologických, psychiatrických nebo metabolických poruch
  • Známé alergie, přecitlivělost nebo intolerance na JNJ-77242113 nebo jeho pomocné látky

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: JNJ-77242113
Účastníci obdrží JNJ-77242113 od týdne 0 do týdne 156.
Lék: JNJ-77242113
JNJ-77242113 bude podáván orálně.
Komparátor placeba: Placebo
Účastníci budou dostávat placebo od týdne 0 do týdne 16 a poté budou dostávat JNJ-77242113 od týdne 16 do týdne 156.
Lék: Placebo
Placebo bude podáváno perorálně.
Lék: JNJ-77242113
JNJ-77242113 bude podáván orálně.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Změna od výchozí hodnoty v celkovém skóre PASI v týdnu 16
Časové okno: Výchozí hodnota (týden 0), týden 16
Změna oproti výchozí hodnotě v celkovém skóre PASI v týdnu 16 byla hlášena. PASI byl systém používaný pro hodnocení a klasifikaci závažnosti psoriatických lézí a jejich odpovědi na léčbu. V systému PASI bylo tělo rozděleno do 4 oblastí: hlava, trup, horní končetiny a dolní končetiny. Každá z těchto oblastí byla hodnocena a bodována samostatně pro zarudnutí, zatvrdnutí a šupinatění, přičemž každý z těchto příznaků byl hodnocen na stupnici od 0 do 4 (0 = žádný, 1 = mírný, 2 = střední, 3 = těžký a 4 = velmi těžký) a rozsah postižení od 0 (naznačoval žádné postižení) do 6 (90 % - 100 % postižení). PASI vytvořil číselné celkové skóre, které se mohlo pohybovat od 0 (žádná psoriáza) do 72 (maximální psoriáza). Vyšší skóre naznačovalo větší závažnost psoriázy. Výchozí hodnota byla definována jako nejbližší měření provedené před nebo v době data první podání studijního léku.
Výchozí hodnota (týden 0), týden 16
Change From Baseline in Body Surface Area (BSA) at Week 16
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Serious Adverse Events (SAEs)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Janssen Research & Development, LLC

Vyšetřovatelé

  • Ředitel studie: Janssen Research &Development, LLC Clinical trial, Janssen Research & Development, LLC

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Termíny studijních záznamů

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Hlavní termíny studia

Začátek studia (Aktuální)

12. října 2023

Primární dokončení (Aktuální)

19. června 2024

Dokončení studie (Odhadovaný)

17. února 2027

Termíny zápisu do studia

První předloženo

18. října 2023

První předloženo, které splnilo kritéria kontroly kvality

18. října 2023

První zveřejněno (Aktuální)

23. října 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. srpna 2026

Naposledy ověřeno

1. srpna 2026

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Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 77242113PSO3003 (Jiný identifikátor: Janssen Research & Development, LLC)

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