Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Tutkimus JNJ-77242113 potilaiden hoitoon, joilla on kohtalainen tai vaikea plakkipsoriaasi

torstai 2. heinäkuuta 2026 päivittänyt: Janssen Research & Development, LLC

Vaiheen 3 monikeskus, satunnaistettu, kaksoissokkoutettu, lumekontrolloitu ja dekravasitinibiaktiivisella vertailulääkekontrolloitu tutkimus JNJ-77242113:n tehokkuuden ja turvallisuuden arvioimiseksi potilaiden hoidossa, joilla on kohtalainen tai vaikea plakkipsoriaasi

Tutkimuksen tarkoituksena on selvittää, kuinka tehokas JNJ-77242113 on potilailla, joilla on kohtalainen tai vaikea läiskäpsoriaasi verrattuna lumelääkkeeseen ja dekravasitinibiin.

Tutkimuksen yleiskatsaus

Tila

Aktiivinen, ei rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

774

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

  • Plakkipsoriaasin diagnoosi nivelpsoriaasin (PsA) kanssa tai ilman sitä vähintään 26 viikon ajan ennen ensimmäistä tutkimustoimenpidettä
  • Kehon kokonaispinta-ala (BSA) suurempi tai yhtä suuri kuin (>=)10 prosenttia (%) seulonnassa ja lähtötilanteessa
  • Psoriaasin kokonaispinta-ala ja vaikeusindeksi (PASI) >=12 seulonnassa ja lähtötilanteessa
  • Tutkijan kokonaisarviointi (IGA) >=3 seulonnassa ja lähtötilanteessa
  • Ehdokas läiskäpsoriaasin valohoitoon tai systeemiseen hoitoon

Poissulkemiskriteerit:

  • Psoriaasin ei-plakkimuoto (esimerkiksi erytroderminen, guttate tai märkärakkulainen)
  • Nykyinen lääkkeiden aiheuttama psoriaasi (esimerkiksi psoriaasin uusi puhkeaminen tai psoriaasin paheneminen beetasalpaajista, kalsiumkanavasalpaajista tai litiumista)
  • Nykyinen diagnoosi tai merkit tai oireet vakavista, progressiivisista tai hallitsemattomista munuaisten, maksan, sydämen, verisuonten, keuhkojen, maha-suolikanavan, endokriinisistä, neurologisista, hematologisista, reumatologisista, psykiatrisista tai aineenvaihduntahäiriöistä
  • Tunnettu allergia, yliherkkyys tai intoleranssi JNJ-77242113:lle tai sen apuaineille
  • Suuri kirurginen toimenpide (esimerkiksi yleisanestesiaa vaativa) 8 viikon sisällä ennen seulontaa tai se ei ole täysin toipunut kirurgisesta toimenpiteestä tai sille on suunniteltu kirurginen toimenpide sinä aikana, jona osallistujan odotetaan osallistuvan tutkimukseen

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: JNJ-77242113
Osallistujat saavat JNJ-77242113 viikolta 0 viikolle 156 ja dekravacitinibia vastaavaa lumelääkettä viikolta 0 viikolle 24.
Lääke: JNJ-77242113
JNJ-77242113 annetaan suun kautta.
Lääke: Dekravacitinib Vastaava Placebo
Dekravasitinibiä vastaava lumelääke annetaan suun kautta.
Placebo Comparator: Plasebo
Osallistujat saavat vastaavaa lumelääkettä JNJ-77242113:lle viikoilta 0–16, vastaavan lumelääkkeen dekravacitinibille viikoilta 0–24 ja JNJ-77242113 viikoilta 16–156.
Lääke: JNJ-77242113
JNJ-77242113 annetaan suun kautta.
Lääke: JNJ-77242113 Vastaava placebo
JNJ-77242113 vastaavaa lumelääkettä annetaan suun kautta.
Lääke: Dekravacitinib Vastaava Placebo
Dekravasitinibiä vastaava lumelääke annetaan suun kautta.
Active Comparator: Dekravasitinibi
Osallistujat saavat dekravasitinibia viikoilta 0–24 ja vastaavaa lumelääkettä JNJ-77242113:lle viikosta 0–24 ja JNJ-77242113:lle viikosta 24 viikolle 156.
Lääke: JNJ-77242113
JNJ-77242113 annetaan suun kautta.
Lääke: JNJ-77242113 Vastaava placebo
JNJ-77242113 vastaavaa lumelääkettä annetaan suun kautta.
Lääke: Dekravasitinibi
Dekravasitinibi annetaan suun kautta.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline in Body Surface Area (BSA) at Week 16
Aikaikkuna: Baseline (Week 0), Week 16
A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Week 16
The GenPs-SFQ was a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days. Item 1 assesses overall frequency of sexual activity in the last 7 days (none/zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (0 = never, 1 = rarely, 2 = sometimes, 3 = often, or 4 = always). Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Dermatological Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1
Aikaikkuna: Week 16
The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1
Aikaikkuna: Weeks 16 and 24
The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 75 at Weeks 4 and 16
Aikaikkuna: Weeks 4 and 16
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 4 and 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 4 and 16
Percentage of Participants Who Achieved PASI 90 at Week 8
Aikaikkuna: Week 8
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 8 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 8
Percentage of Participants Who Achieved PASI 100 at Week 16
Aikaikkuna: Week 16
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved a Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2
Aikaikkuna: 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
Aikaikkuna: Weeks 16 and 24
IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation, =0.25 mm; 2=mild plaque elevation, =0.5 mm; 3=moderate plaque elevation, =0.75 mm; 4=severe plaque elevation, >1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over <5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 75 at Weeks 16 and 24
Aikaikkuna: Weeks 16 and 24
Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 90 at Weeks 16 and 24
Aikaikkuna: Weeks 16 and 24
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PASI 100 at Weeks 16 and 24
Aikaikkuna: Weeks 16 and 24
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Weeks 16 and 24
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With a Baseline Symptom Score >0
Aikaikkuna: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date
Week 16
Change From Baseline in PASI Total Score at Week 16
Aikaikkuna: Baseline (Week 0), Week 16
Change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percent Change From Baseline in PASI Total Score at Week 16
Aikaikkuna: Baseline (Week 0), Week 16
Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-grade Improvement at Week 16 Among Participants With a Baseline sPGA-G Score >=2
Aikaikkuna: Week 16
The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Higher score indicates more severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and a >=2-grade Improvement at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
Aikaikkuna: 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
Aikaikkuna: Baseline (Week 0), Week 16
Percent change from baseline in mNAPSI score at week 16 was reported. The mNAPSI was an index used for assessing and grading the severity of nail psoriasis. Each of the participant's ten fingernails were evaluated on 7 features. The first three features were each scored from 0 to 3 in severity and were 1 = onycholysis and oil-drop dyschromia, 2 = pitting, and 3 = nail plate crumbling. Next four features was each scored 0 absent or 1 present, and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in lunula. Each fingernail was rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). Total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). Higher the score the more severe the nail bed psoriasis. Baseline = closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With Baseline f-PGA Score >=2
Aikaikkuna: Week 16
Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in PSSD Symptom Score at Week 16
Aikaikkuna: Baseline (Week 0), Week 16
Change from baseline in PSSD symptoms score at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date
Baseline (Week 0), Week 16
Change From Baseline in PSSD Sign Score at Week 16
Aikaikkuna: Baseline (Week 0), Week 16
Change from baseline in PSSD sign score at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Change From Baseline in Total DLQI Score at Week 16
Aikaikkuna: Baseline (Week 0), Week 16
Change from baseline in total DLQI score at Week 16 was reported. The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Change From Baseline in Domain Scores of the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
Aikaikkuna: Baseline (Week 0), Week 16
PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T-score=more of concept being measured i.e. higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 24 Among Participants With Baseline Symptom Score >0
Aikaikkuna: Week 24
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date
Week 24
Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24
Aikaikkuna: Week 24 up to Week 160
Week 24 up to Week 160
Percentage of Participants Who Achieved PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24
Aikaikkuna: Week 24 up to Week 160
Week 24 up to Week 160
Percentage of Participants Who Achieved IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24
Aikaikkuna: Week 24 up to Week 160
Week 24 up to Week 160
Number of Participants With Adverse Events (AEs)
Aikaikkuna: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Serious Adverse Events (SAEs)
Aikaikkuna: From Week 0 to Week 160
From Week 0 to Week 160

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Janssen Research & Development, LLC

Tutkijat

  • Opintojohtaja: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Torstai 1. helmikuuta 2024

Ensisijainen valmistuminen (Todellinen)

Tiistai 17. syyskuuta 2024

Opintojen valmistuminen (Arvioitu)

Tiistai 1. kesäkuuta 2027

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 14. marraskuuta 2023

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 16. marraskuuta 2023

Ensimmäinen Lähetetty (Todellinen)

Keskiviikko 22. marraskuuta 2023

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 7. heinäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 2. heinäkuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. heinäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 77242113PSO3002 (Muu tunniste: Janssen Research & Development, LLC)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

Johnson & Johnsonin Janssen Pharmaceutical Companiesin tiedonjakopolitiikka on saatavilla osoitteessa www.janssen.com/clinical-trials/transparency. Kuten tällä sivustolla mainitaan, tutkimustietoihin pääsyä koskevat pyynnöt voidaan lähettää Yale Open Data Access (YODA) -projektisivuston kautta osoitteessa yoda.yale.edu

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa