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Badanie JNJ-77242113 dotyczące leczenia uczestników chorych na łuszczycę plackowatą o nasileniu umiarkowanym do ciężkiego (ICONIC-ADVANCE 2)

24 września 2026 zaktualizowane przez: Janssen Research & Development, LLC

Wieloośrodkowe, randomizowane badanie III fazy z podwójnie ślepą próbą, kontrolowane placebo i kontrolowane aktywnym komparatorem deukrawacytynibu, mające na celu ocenę skuteczności i bezpieczeństwa JNJ-77242113 w leczeniu uczestników z umiarkowaną do ciężkiej łuszczycą plackowatą

The purpose of the study is to evaluate how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

Przegląd badań

Status

Status

Wskazuje aktualny stan rekrutacji lub stan rozszerzonego dostępu.
Aktywny, nie rekrutujący

Warunki

Warunki

Badana choroba, zaburzenie, zespół, choroba lub uraz. Na stronie ClinicalTrials.gov warunki mogą również obejmować inne kwestie związane ze zdrowiem, takie jak długość życia, jakość życia i zagrożenia dla zdrowia.

Interwencja / Leczenie

Interwencja / Leczenie

Proces lub działanie będące przedmiotem badania klinicznego. Interwencje obejmują leki, urządzenia medyczne, procedury, szczepionki i inne produkty, które są w fazie badań lub są już dostępne. Interwencje mogą również obejmować podejścia nieinwazyjne, takie jak edukacja lub modyfikacja diety i ćwiczeń.

Typ studiów

Typ studiów

Opisuje charakter badania klinicznego. Rodzaje badań obejmują badania interwencyjne (zwane także badaniami klinicznymi), badania obserwacyjne (w tym rejestry pacjentów) i rozszerzony dostęp.
Interwencyjne

Zapisy (Rzeczywisty)

Zapisy

Liczba uczestników badania klinicznego. „Przewidywana” rekrutacja to docelowa liczba uczestników, których naukowcy potrzebują do badania.
731

Faza

Faza

Etap badania klinicznego badającego lek lub produkt biologiczny w oparciu o definicje opracowane przez amerykańską Agencję ds. Żywności i Leków (FDA). Faza opiera się na celu badania, liczbie uczestników i innych cechach. Istnieje pięć faz: wczesna faza 1 (wcześniej wymieniona jako faza 0), faza 1, faza 2, faza 3 i faza 4. Nie dotyczy jest używany do opisania badań bez faz zdefiniowanych przez FDA, w tym prób urządzeń lub interwencji behawioralnych.
  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Australia
      • Benowa, Australia, 4217
        • The Skin Centre
      • Clayton, Australia, 3168
        • Monash Medical Centre
      • Kogarah, Australia, 2217
        • Premier Specialists
      • Melbourne, Australia, 3004
        • The Alfred Hospital
      • Mitcham, Australia, 3132
        • ISHI dermatology
      • Parkville, Australia, 3050
        • Royal Melbourne Hospital
  • Brazylia
      • Botucatu, Brazylia, 18618-686
        • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
      • Brasília, Brazylia, 72145-450
        • Chronos Clinica Medica Ltda
      • Ribeirão Preto, Brazylia, 14051140
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
      • São José do Rio Preto, Brazylia, 15090-000
        • Funfarme Sjrp
      • São Paulo, Brazylia, 05403 900
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
      • São Paulo, Brazylia, 09060-870
        • Cepes - Fmabc
  • Hiszpania
      • Alcorcón, Hiszpania, 28922
        • Hosp. Univ. Fundacion Alcorcon
      • Badalona, Hiszpania, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Hiszpania, 08036
        • Hosp Clinic de Barcelona
      • Manises, Hiszpania, 46940
        • Hosp. de Manises
      • Salamanca, Hiszpania, 37007
        • Hosp Clinico Univ de Salamanca
      • Santiago de Compostela, Hiszpania, 15702
        • Clinica Gaias
      • Santiago de Compostela, Hiszpania, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Hiszpania, 41009
        • Hosp. Virgen Macarena
      • Seville, Hiszpania, 41014
        • Hosp. Ntra. Sra. de Valme
      • Villajoyosa, Hiszpania, 03570
        • Hosp. de La Marina Baixa
      • Zaragoza, Hiszpania, 50009
        • Hosp. Clinico Univ. Lozano Blesa
  • Kanada
    • British Columbia
      • Surrey, British Columbia, Kanada, V3R 6A7
        • Dr. Chih ho Hong Medical
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3M 3Z4
        • Wiseman Dermatology Research Inc.
    • Ontario
      • London, Ontario, Kanada, N6A 5R9
        • Lovegrove Dermatology
      • Markham, Ontario, Kanada, L3P 1X2
        • Lynderm Research Inc.
      • Mississauga, Ontario, Kanada, L4Y 4C5
        • DermEdge Research
      • Peterborough, Ontario, Kanada, K9J 5K2
        • Skin Centre for Dermatology
      • Toronto, Ontario, Kanada, M2N 3A6
        • North York Research Inc
      • Toronto, Ontario, Kanada, M3N 1A8
        • Avenue Research Group
      • Windsor, Ontario, Kanada, N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, Kanada, H2X 2V1
        • Innovaderm Research Inc.
      • Québec, Quebec, Kanada, G1V 4X7
        • Centre De Recherche Dermatologique Du Quebec Metropolitain
  • Korea Południowa
      • Ansan-si, Korea Południowa, 15355
        • Korea University Ansan Hospital
      • Anyang-si, Korea Południowa, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon-si, Korea Południowa, 14647
        • The Catholic University of Korea Bucheon St Mary s Hospital
      • Gwangju, Korea Południowa, 61453
        • Chosun university hospital
      • Seongnam, Korea Południowa, 13496
        • CHA Bundang Medical Center, CHA University
      • Seoul, Korea Południowa, 05505
        • Asan Medical Center
      • Seoul, Korea Południowa, 8308
        • Korea University Guro Hospital
  • Niemcy
      • Augsburg, Niemcy, 86150
        • Hautarztpraxis Dr. Mihaescu
      • Bad Bentheim, Niemcy, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Niemcy, 13627
        • CRS Clinical Research Services Berlin GmbH
      • Bochum, Niemcy, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, Niemcy, 64283
        • Klinikum Darmstadt GmbH - Hautklinik
      • Dresden, Niemcy, 01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Dülmen, Niemcy, 48249
        • Hautzentrum Dulmen
      • Düsseldorf, Niemcy, 40212
        • Privatpraxis Dr. Hilton & Partner
      • Friedrichshafen, Niemcy, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Hamburg, Niemcy, 20095
        • Eurofins bioskin GmbH
      • Heidelberg, Niemcy, 69120
        • Universitaetsklinikum Heidelberg
      • Mahlow, Niemcy, 15831
        • Hautarztpraxis
      • Mainz, Niemcy, 55131
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
      • Merzig, Niemcy, 66663
        • Hautmedizin Saar Science Hms GmbH
      • Münster, Niemcy, 48149
        • Universitaetsklinikum Muenster
      • Oldenburg, Niemcy, 26133
        • Klinikum Oldenburg
      • Witten, Niemcy, 58453
        • Hautarztpraxis 1
      • Wuppertal, Niemcy, 42287
        • CentroDerm GmbH
  • Polska
      • Bialystok, Polska, 15 797
        • Renew Clinic
      • Katowice, Polska, 40 611
        • Centrum Medyczne Angelius Provita
      • Katowice, Polska, 40 568
        • Care Clinic
      • Kielce, Polska, 25-316
        • Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
      • Krakow, Polska, 30-002
        • SGD s.c.
      • Krakow, Polska, 30-303
        • Krakowskie Centrum Badan Klinicznych
      • Krakow, Polska, 30-348
        • Jagiellonskie Centrum Innowacji
      • Krakow, Polska, 31 559
        • Diamond Clinic
      • Olsztyn, Polska, 10-117
        • Etyka Osrodek Badan Klinicznych
      • Warsaw, Polska, 02-962
        • Royalderm Agnieszka Nawrocka
      • Warsaw, Polska, 02 661
        • Carpe Diem Centrum Medycyny Estetycznej
      • Warsaw, Polska, 02 672
        • Synexus Polska Sp z o o Oddzial w Warszawie
      • Wroclaw, Polska, 51 685
        • WroMedica I Bielicka A Strzalkowska s c
  • Rumunia
      • Cluj-Napoca, Rumunia, 400105
        • Cabinet Medical Dermato-Venerologie
      • Craiova, Rumunia, 200541
        • Centrul Medical Vitaplus
      • Craiova, Rumunia, 200642
        • Spitalul Clinic Judetean de Urgenta
      • Iași, Rumunia, 700381
        • Sc Iasiprest Srl
      • Oradea, Rumunia, 410167
        • Spitalul Clinic Judetean de Urgenta Bihor
      • Timișoara, Rumunia, 300757
        • New Derm Clinic
      • Târgu Mureş, Rumunia, 540342
        • Spitalul Clinic Judetean Mures
  • Stany Zjednoczone
    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone, 85032
        • Alliance Dermatology and MOHS Center P C
    • California
      • Encinitas, California, Stany Zjednoczone, 92024
        • California Dermatology & Clinical Research Institute
      • Encino, California, Stany Zjednoczone, 91436
        • T Joseph Raoof Md Inc
      • Fresno, California, Stany Zjednoczone, 93701
        • UCSF Fresno
      • Los Angeles, California, Stany Zjednoczone, 90056
        • Wallace Medical Group, Inc
      • Los Angeles, California, Stany Zjednoczone, 90024
        • University of California Los Angeles - Division of Dermatology
      • Oceanside, California, Stany Zjednoczone, 92056
        • Dermatologist Medical Group of North County, Inc.
    • Florida
      • Miami, Florida, Stany Zjednoczone, 33155
        • Bioclinical Research Alliance Inc.
      • Miami, Florida, Stany Zjednoczone, 33133
        • Miami Dermatology And Laser Institute
      • Tampa, Florida, Stany Zjednoczone, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Douglasville, Georgia, Stany Zjednoczone, 30135
        • Southeast Dermatology Specialists
    • Illinois
      • Rolling Meadows, Illinois, Stany Zjednoczone, 60008
        • Arlington Dermatology
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40217
        • Skin Sciences, PLLC
      • Owensboro, Kentucky, Stany Zjednoczone, 42301
        • Qualmedica Research
    • Maryland
      • Rockville, Maryland, Stany Zjednoczone, 20850
        • DermAssociates, PC
    • Massachusetts
      • Brighton, Massachusetts, Stany Zjednoczone, 02135
        • Metro Boston Clinical Partners
      • Methuen, Massachusetts, Stany Zjednoczone, 01844
        • ActivMed Practices and Research
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48109
        • University of Michigan
      • Bay City, Michigan, Stany Zjednoczone, 48706
        • Great Lakes Research Group
      • Caledonia, Michigan, Stany Zjednoczone, 49316
        • The Derm Institute of West Michigan
      • Canton, Michigan, Stany Zjednoczone, 48187
        • Hamzavi Dermatology
      • Troy, Michigan, Stany Zjednoczone, 48084
        • Somerset Skin Centre
    • Missouri
      • Kirksville, Missouri, Stany Zjednoczone, 63501
        • Cleaver Dermatology
    • Ohio
      • Bexley, Ohio, Stany Zjednoczone, 43209
        • Bexley dermatology research
    • Oklahoma
      • Tulsa, Oklahoma, Stany Zjednoczone, 74137
        • Essential Medical Research
    • Oregon
      • Portland, Oregon, Stany Zjednoczone, 97210-2996
        • Oregon Dermatology & Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19103
        • Paddington Testing Co, Inc.
    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone, 29407
        • Clinical Research Center of the Carolinas LLC
      • Greenville, South Carolina, Stany Zjednoczone, 29615
        • Palmetto Clinical Trial Services, LLC
    • Texas
      • Arlington, Texas, Stany Zjednoczone, 76011
        • Arlington Research Center, Inc.
      • Dallas, Texas, Stany Zjednoczone, 75390
        • UT Southwestern Medical Center
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Dermatology Clinical Research Center of San Antonio
      • Webster, Texas, Stany Zjednoczone, 77598
        • Center for Clinical Studies
    • Utah
      • Bountiful, Utah, Stany Zjednoczone, 84010
        • Cope Family Medicine - Ogden Clinic
      • Springville, Utah, Stany Zjednoczone, 84663
        • Springville Dermatology CCT Research
      • West Valley City, Utah, Stany Zjednoczone, 84120
        • Kalo Clinical Research
    • Virginia
      • Norfolk, Virginia, Stany Zjednoczone, 23502
        • Virginia Dermatology Skin Cancer Center Pllc
  • Tajwan
      • Kaohsiung City, Tajwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Tajwan, 80756
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Taichung, Tajwan, 40705
        • Taichung Veterans General Hospital
      • Taichung, Tajwan, 40201
        • Chung Shan Medical University Hospital
      • Tainan, Tajwan, 710
        • National Cheng Kung University Hospital
      • Taipei, Tajwan, 110
        • Taipei Medical University
      • Taipei, Tajwan, 116
        • Taipei Municipal Wanfang Hospital
  • Węgry
      • Budapest, Węgry, 1152
        • Uno Medical Trials Ltd.
      • Gyula, Węgry, 5700
        • Synexus Magyarorszag Kft
      • Gyöngyös, Węgry, 3200
        • Bugat Pal Korhaz
      • Kecskemét, Węgry, 6000
        • Bacs Kiskun Varmegyei Oktatokorhaz
      • Zalaegerszeg, Węgry, H-8900
        • Synexus Magyarorszag Kft 1

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Kryteria kwalifikacji

Kluczowe wymagania, które muszą spełniać osoby chcące wziąć udział w badaniu klinicznym lub cechy, które muszą posiadać. Kryteria kwalifikowalności obejmują zarówno kryteria włączenia (które są wymagane, aby dana osoba mogła uczestniczyć w badaniu), jak i kryteria wykluczenia (które uniemożliwiają osobie udział). Rodzaje kryteriów kwalifikowalności obejmują to, czy badanie akceptuje zdrowych ochotników, ma wymagania dotyczące wieku lub grupy wiekowej lub jest ograniczone ze względu na płeć.

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
  • Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
  • Total psoriasis area and severity index (PASI) >=12 at screening and baseline
  • Total investigator global assessment (IGA) >=3 at screening and baseline
  • Candidate for phototherapy or systemic treatment for plaque psoriasis

Exclusion Criteria:

  • Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
  • Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
  • A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Known allergies, hypersensitivity, or intolerance to JNJ-77242113, deucravacitinib or to any of the excipients or components of the study intervention
  • Major surgical procedure, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm

Grupa uczestników / Arm

Grupa lub podgrupa uczestników badania klinicznego, którzy zgodnie z protokołem badania otrzymują określoną interwencję/leczenie lub nie otrzymują żadnej interwencji.
Interwencja / Leczenie

Interwencja / Leczenie

Proces lub działanie będące przedmiotem badania klinicznego. Interwencje obejmują leki, urządzenia medyczne, procedury, szczepionki i inne produkty, które są w fazie badań lub są już dostępne. Interwencje mogą również obejmować podejścia nieinwazyjne, takie jak edukacja lub modyfikacja diety i ćwiczeń.
Eksperymentalny: JNJ-77242113

Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.
Lek: JNJ-77242113

JNJ-77242113 will be administered orally.

Lek: Deucravacitinib Matching Placebo

Deucravacitinib matching placebo will be administered orally.
Komparator placebo: Placebo

Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.
Lek: JNJ-77242113

JNJ-77242113 will be administered orally.

Lek: Deucravacitinib Matching Placebo

Deucravacitinib matching placebo will be administered orally.

Lek: JNJ-77242113 Matching Placebo

JNJ-77242113 matching placebo will be administered orally.
Aktywny komparator: Deucravacitinib

Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.
Lek: JNJ-77242113

JNJ-77242113 will be administered orally.

Lek: JNJ-77242113 Matching Placebo

JNJ-77242113 matching placebo will be administered orally.

Lek: Deucravacitinib

Deucravacitinib will be administered orally.

Co mierzy badanie?

Podstawowe miary wyniku

Podstawowe miary wyniku

W protokole badania klinicznego planowana miara wyniku, która jest najważniejsza dla oceny efektu interwencji/leczenia. Większość badań klinicznych ma jedną główną miarę wyniku, ale niektóre mają więcej niż jedną.
Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
Ramy czasowe: Week 16

IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using 5 point scale. Induration: 0 =no evidence of plaque elevation, 1=minimal plaque elevation,= 0.25 millimeters (mm); 2=mild plaque elevation,= 0.5 mm; 3=moderate plaque elevation,= 0.75 mm; 4=severe plaque elevation, greater than (>) 1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at the time of first study drug administration date.
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Ramy czasowe: 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

Miary wyników drugorzędnych

Miary wyników drugorzędnych

W protokole badania klinicznego planowana miara wyniku, która nie jest tak ważna jak główna miara wyniku w ocenie efektu interwencji, ale nadal jest interesująca. Większość badań klinicznych ma więcej niż jedną drugorzędową miarę wyniku.
Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24
Ramy czasowe: From Week 24 up to Week 160
From Week 24 up to Week 160
Percentage of Participants Achieving PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24
Ramy czasowe: From Week 24 up to Week 160
From Week 24 up to Week 160
Percentage of Participants Achieving IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24
Ramy czasowe: From Week 24 up to Week 160
From Week 24 up to Week 160
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Ramy czasowe: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Ramy czasowe: From Week 0 to Week 160
From Week 0 to Week 160
Change From Baseline in PASI Total Score at Week 16
Ramy czasowe: 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 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
Percent Change From Baseline in PASI Total Score at Week 16
Ramy czasowe: 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
Change From Baseline in Body Surface Area (BSA) at Week 16
Ramy czasowe: 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 Dermatological Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1
Ramy czasowe: 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 IGA Score of 0 at Week 16
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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 DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1
Ramy czasowe: 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 Response at Weeks 4 and 16
Ramy czasowe: Weeks 4 and 16

Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 4 and 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 4 and 16
Percentage of Participants Who Achieved PASI 90 Response at Week 8
Ramy czasowe: Week 8

Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 8 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 8
Percentage of Participants Who Achieved PASI 100 Response at Week 16
Ramy czasowe: 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 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
Ramy czasowe: 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
Ramy czasowe: Weeks 16 and 24

IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25mm; 2=mild plaque elevation,=0.5 mm; 3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation,>1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score=more severe disease.Baseline=closest measurement taken prior to or at time of first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24
Ramy czasowe: Weeks 16 and 24

Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24
Ramy czasowe: Weeks 16 and 24

Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 100 Response at Weeks 16 and 24
Ramy czasowe: Weeks 16 and 24

Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With a Baseline PSSD Symptom Score >0
Ramy czasowe: Week 16

PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline sPGA-G Score >=2
Ramy czasowe: Week 16

The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Higher score indicates more severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and a >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
Ramy czasowe: 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
Ramy czasowe: Baseline (Week 0), Week 16

Percent change from baseline in mNAPSI score at week 16 was reported. The mNAPSI was an index used for assessing and grading the severity of nail psoriasis. Each of the participant's ten fingernails were evaluated on 7 features. The first three features were each scored from 0 to 3 in severity and were 1=onycholysis and oil-drop dyschromia, 2=pitting, and 3=nail plate crumbling. Next four features was each scored 0 (absent) or 1 (present), and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in lunula. Each fingernail was rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). Total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). Higher the score the more severe the nail bed psoriasis. Baseline=closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With a Baseline f-PGA Score >=2
Ramy czasowe: Week 16

Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. Baseline = closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in PSSD Symptom Score at Week 16
Ramy czasowe: Baseline (Week 0), Week 16

Change from baseline in PSSD symptoms scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Change From Baseline in PSSD Sign Score at Week 16
Ramy czasowe: Baseline (Week 0), Week 16

Change from baseline in PSSD sign scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Change From Baseline in Total DLQI Score at Week 16
Ramy czasowe: Baseline (Week 0), Week 16

The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Change From Baseline in Domain Scores of the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
Ramy czasowe: Baseline (Week 0), Week 16

PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T-score=more of concept being measured that is higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning. Baseline: closest measurement taken prior to or at time of first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved PSSD Symptoms Score of 0 at Week 24 Among Participants With a Baseline PSSD Symptom Score >0
Ramy czasowe: 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

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Janssen Research & Development, LLC

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9 marca 2024

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20 września 2027

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15 stycznia 2024

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15 stycznia 2024

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24 stycznia 2024

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Najnowsza data udostępnienia zmian w rekordzie badania na stronie ClinicalTrials.gov. Może wystąpić opóźnienie między momentem przesłania zmian do ClinicalTrials.gov przez sponsora badania lub badacza (data ostatniego przesłania aktualizacji) a datą ostatniego opublikowania aktualizacji.
28 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Najnowsza data, w której sponsor badania lub badacz przesłał zmiany w rekordzie badania, które są zgodne z kryteriami przeglądu kontroli jakości (QC) National Library of Medicine (NLM). Obowiązkiem sponsora lub badacza jest upewnienie się, że zapis badania jest zgodny z kryteriami przeglądu NLM QC.
24 września 2026

Ostatnia weryfikacja

Ostatnia weryfikacja

Najnowsza data, w której sponsor badania lub badacz potwierdził, że informacje o badaniu klinicznym na stronie ClinicalTrials.gov są dokładne i aktualne. Jeśli badanie ze statusem rekrutacji to rekrutacja; jeszcze nie rekrutacja; lub aktywny, brak rekrutacji nie został potwierdzony w ciągu ostatnich 2 lat, status rekrutacji do badania jest pokazany jako nieznany.
1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

Inne numery identyfikacyjne badania

Identyfikatory lub numery identyfikacyjne inne niż numer NCT, które są przypisane do badania klinicznego przez sponsora badania, podmioty finansujące lub inne osoby. Numery te mogą zawierać unikalne identyfikatory z innych rejestrów badań i numery grantów National Institutes of Health.
  • 77242113PSO3004
  • 77242113PSO3004 (Inny identyfikator: Janssen Research & Development, LLC)
  • 2023-507039-39-00 (Identyfikator rejestru: EUCT number)
  • 2023 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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