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En studie av JNJ-77242113 for behandling av deltakere med moderat til alvorlig plakkpsoriasis (ICONIC-ADVANCE 2)

27. august 2026 oppdatert av: Janssen Research & Development, LLC

En fase 3 multisenter, randomisert, dobbeltblind, placebokontrollert og Deucravacitinib Active Comparator-kontrollert studie for å evaluere effektiviteten og sikkerheten til JNJ-77242113 for behandling av deltakere med moderat til alvorlig plakkpsoriasis

Formålet med studien er å evaluere hvor effektiv JNJ-77242113 er hos deltakere med moderat til alvorlig plakkpsoriasis sammenlignet med placebo og deucravacitinib.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

731

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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
  • Brasil
      • Botucatu, Brasil, 18618-686
        • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
      • Brasília, Brasil, 72145-450
        • Chronos Clinica Medica Ltda
      • Ribeirão Preto, Brasil, 14051140
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
      • São José do Rio Preto, Brasil, 15090-000
        • Funfarme Sjrp
      • São Paulo, Brasil, 05403 900
        • Hospital das Clínicas da Faculdade de Medicina da USP
      • São Paulo, Brasil, 09060-870
        • Cepes - Fmabc
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih ho Hong Medical
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research Inc.
    • Ontario
      • London, Ontario, Canada, N6A 5R9
        • Lovegrove Dermatology
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc.
      • Mississauga, Ontario, Canada, L4Y 4C5
        • DermEdge Research
      • Peterborough, Ontario, Canada, K9J 5K2
        • SKiN Centre for Dermatology
      • Toronto, Ontario, Canada, M3H 5Y8
        • Toronto Research Centre
      • Toronto, Ontario, Canada, M2N 3A6
        • North York Research Inc
      • Windsor, Ontario, Canada, N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research Inc.
      • Québec, Quebec, Canada, G1V 4X7
        • Centre de Recherche Dermatologique du Quebec metropolitain
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85032
        • Alliance Dermatology and MOHS Center P C
    • California
      • Encinitas, California, Forente stater, 92024
        • California Dermatology & Clinical Research Institute
      • Encino, California, Forente stater, 91436
        • T Joseph Raoof Md Inc
      • Fresno, California, Forente stater, 93701
        • Ucsf Fresno
      • Los Angeles, California, Forente stater, 90056
        • Wallace Medical Group, Inc
      • Los Angeles, California, Forente stater, 90024
        • University of California Los Angeles - Division of Dermatology
      • Oceanside, California, Forente stater, 92056
        • Dermatologist Medical Group of North County, Inc.
    • Florida
      • Miami, Florida, Forente stater, 33155
        • Bioclinical Research Alliance Inc.
      • Miami, Florida, Forente stater, 33133
        • Miami Dermatology And Laser Institute
      • Tampa, Florida, Forente stater, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Douglasville, Georgia, Forente stater, 30135
        • Southeast Dermatology Specialists
    • Illinois
      • Rolling Meadows, Illinois, Forente stater, 60008
        • Arlington Dermatology
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40217
        • Skin Sciences, PLLC
      • Owensboro, Kentucky, Forente stater, 42301
        • Qualmedica Research
    • Maryland
      • Rockville, Maryland, Forente stater, 20850
        • DermAssociates, PC
    • Massachusetts
      • Brighton, Massachusetts, Forente stater, 02135
        • Metro Boston Clinical Partners
      • Methuen, Massachusetts, Forente stater, 01844
        • ActivMed Practices and Research
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan
      • Bay City, Michigan, Forente stater, 48706
        • Great Lakes Research Group
      • Caledonia, Michigan, Forente stater, 49316
        • The Derm Institute of West Michigan
      • Canton, Michigan, Forente stater, 48187
        • Hamzavi Dermatology
      • Troy, Michigan, Forente stater, 48084
        • Somerset Skin Centre
    • Missouri
      • Kirksville, Missouri, Forente stater, 63501
        • Cleaver Dermatology
    • Ohio
      • Bexley, Ohio, Forente stater, 43209
        • Bexley Dermatology Research
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74137
        • Essential Medical Research
    • Oregon
      • Portland, Oregon, Forente stater, 97210-2996
        • Oregon Dermatology & Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19103
        • Paddington Testing Co, Inc.
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29407
        • Clinical Research Center of the Carolinas LLC
      • Greenville, South Carolina, Forente stater, 29615
        • Palmetto Clinical Trial Services, LLC
    • Texas
      • Arlington, Texas, Forente stater, 76011
        • Arlington Research Center, inc.
      • Dallas, Texas, Forente stater, 75390
        • UT Southwestern Medical Center
      • San Antonio, Texas, Forente stater, 78229
        • Dermatology Clinical Research Center of San Antonio
      • Webster, Texas, Forente stater, 77598
        • Center for Clinical Studies
    • Utah
      • Bountiful, Utah, Forente stater, 84010
        • Cope Family Medicine - Ogden Clinic
      • Springville, Utah, Forente stater, 84663
        • Springville Dermatology CCT Research
      • West Valley City, Utah, Forente stater, 84120
        • Kalo Clinical Research
    • Virginia
      • Norfolk, Virginia, Forente stater, 23502
        • Virginia Dermatology Skin Cancer Center Pllc
  • Polen
      • Bialystok, Polen, 15 797
        • Renew Clinic
      • Katowice, Polen, 40 568
        • CaRe Clinic
      • Katowice, Polen, 40 611
        • Centrum Medyczne Angelius Provita
      • Kielce, Polen, 25-316
        • Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
      • Krakow, Polen, 30-002
        • SGD s.c.
      • Krakow, Polen, 30-303
        • Krakowskie Centrum Badan Klinicznych
      • Krakow, Polen, 30-348
        • Jagiellonskie Centrum Innowacji
      • Krakow, Polen, 31 559
        • Diamond Clinic
      • Olsztyn, Polen, 10-117
        • Etyka Osrodek Badan Klinicznych
      • Warsaw, Polen, 02-962
        • Royalderm Agnieszka Nawrocka
      • Warsaw, Polen, 02 661
        • Carpe Diem Centrum Medycyny Estetycznej
      • Warsaw, Polen, 02 672
        • Synexus Polska Sp z o o Oddzial w Warszawie
      • Wroclaw, Polen, 51 685
        • WroMedica I Bielicka A Strzalkowska s c
  • Romania
      • Cluj-Napoca, Romania, 400105
        • Cabinet Medical Dermato-Venerologie
      • Craiova, Romania, 200541
        • Centrul Medical Vitaplus
      • Craiova, Romania, 200642
        • Spitalul Clinic Județean de Urgență
      • Iași, Romania, 700381
        • Sc Iasiprest Srl
      • Oradea, Romania, 410167
        • Spitalul Clinic Judetean de Urgenta Bihor
      • Timișoara, Romania, 300757
        • New Derm Clinic
      • Târgu Mureş, Romania, 540342
        • Spitalul Clinic Judetean Mures
  • Spania
      • Alcorcón, Spania, 28922
        • Hosp. Univ. Fundacion Alcorcon
      • Badalona, Spania, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spania, 08036
        • Hosp Clinic de Barcelona
      • Manises, Spania, 46940
        • Hosp. de Manises
      • Salamanca, Spania, 37007
        • Hosp Clinico Univ de Salamanca
      • Santiago de Compostela, Spania, 15702
        • Clinica Gaias
      • Santiago de Compostela, Spania, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Spania, 41009
        • Hosp. Virgen Macarena
      • Seville, Spania, 41014
        • Hosp. Ntra. Sra. de Valme
      • Villajoyosa, Spania, 03570
        • Hosp. de La Marina Baixa
      • Zaragoza, Spania, 50009
        • Hosp. Clinico Univ. Lozano Blesa
  • Sør -Korea
      • Ansan-si, Sør -Korea, 15355
        • Korea University Ansan Hospital
      • Anyang-si, Sør -Korea, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon-si, Sør -Korea, 14647
        • The Catholic University of Korea Bucheon St Mary s Hospital
      • Gwangju, Sør -Korea, 61453
        • Chosun University Hospital
      • Seongnam, Sør -Korea, 13496
        • Cha Bundang Medical Center, Cha University
      • Seoul, Sør -Korea, 05505
        • Asan Medical Center
      • Seoul, Sør -Korea, 8308
        • Korea University Guro Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan, 710
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 110
        • Taipei Medical University
      • Taipei, Taiwan, 116
        • Taipei Municipal Wanfang Hospital
  • Tyskland
      • Augsburg, Tyskland, 86150
        • Hautarztpraxis Dr. Mihaescu
      • Bad Bentheim, Tyskland, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Tyskland, 13627
        • CRS Clinical Research Services Berlin GMBH
      • Bochum, Tyskland, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, Tyskland, 64283
        • Klinikum Darmstadt GmbH - Hautklinik
      • Dresden, Tyskland, 01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Dülmen, Tyskland, 48249
        • Hautzentrum Dulmen
      • Düsseldorf, Tyskland, 40212
        • Privatpraxis Dr. Hilton & Partner
      • Friedrichshafen, Tyskland, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Hamburg, Tyskland, 20095
        • Eurofins bioskin GmbH
      • Heidelberg, Tyskland, 69120
        • Universitaetsklinikum Heidelberg
      • Mahlow, Tyskland, 15831
        • Hautarztpraxis
      • Mainz, Tyskland, 55131
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
      • Merzig, Tyskland, 66663
        • Hautmedizin Saar Science Hms GmbH
      • Münster, Tyskland, 48149
        • Universitaetsklinikum Muenster
      • Oldenburg, Tyskland, 26133
        • Klinikum Oldenburg
      • Witten, Tyskland, 58453
        • Hautarztpraxis 1
      • Wuppertal, Tyskland, 42287
        • CentroDerm GmbH
  • Ungarn
      • Budapest, Ungarn, 1152
        • Uno Medical Trials Ltd.
      • Gyula, Ungarn, 5700
        • Synexus Magyarorszag Kft
      • Gyöngyös, Ungarn, 3200
        • Bugat Pal Korhaz
      • Kecskemét, Ungarn, 6000
        • Bacs Kiskun Varmegyei Oktatokorhaz
      • Zalaegerszeg, Ungarn, H-8900
        • Synexus Magyarorszag Kft 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Diagnostisering av plakkpsoriasis, med eller uten psoriasisartritt (PsA), i minst 26 uker før første administrasjon av studieintervensjon
  • Totalt kroppsoverflateareal (BSA) større enn eller lik (>=)10 prosent (%) ved screening og baseline
  • Total psoriasisareal og alvorlighetsindeks (PASI) >=12 ved screening og baseline
  • Total etterforsker global vurdering (IGA) >=3 ved screening og baseline
  • Kandidat for fototerapi eller systemisk behandling for plakkpsoriasis

Ekskluderingskriterier:

  • Plakfri form for psoriasis (for eksempel erytrodermisk, guttat eller pustulær)
  • Nåværende medikamentindusert psoriasis (for eksempel en ny debut av psoriasis eller en forverring av psoriasis fra betablokkere, kalsiumkanalblokkere eller litium)
  • En nåværende diagnose eller tegn eller symptomer på alvorlige, progressive eller ukontrollerte nyre-, lever-, hjerte-, vaskulære, pulmonale, gastrointestinale, endokrine, nevrologiske, hematologiske, revmatologiske, psykiatriske eller metabolske forstyrrelser
  • Kjente allergier, overfølsomhet eller intoleranse overfor JNJ-77242113 eller dets hjelpestoffer
  • Større kirurgisk prosedyre, (for eksempel krever generell anestesi) innen 8 uker før screening, eller vil ikke ha kommet seg helt etter kirurgisk prosedyre, eller har planlagt en kirurgisk prosedyre i løpet av den tiden deltakeren forventes å delta i studien

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: JNJ-77242113
Deltakerne vil motta JNJ-77242113 fra uke 0 til og med uke 156 og deucravacitinib-matchende placebo fra uke 0 til og med uke 24.
Legemiddel: JNJ-77242113
JNJ-77242113 vil bli administrert oralt.
Legemiddel: Deucravacitinib Matching Placebo
Deucravacitinib-matchende placebo vil bli administrert oralt.
Placebo komparator: Placebo
Deltakerne vil motta matchende placebo for JNJ-77242113 fra uke 0 til uke 16, matchende placebo for deucravacitinib fra uke 0 til uke 24 og JNJ-77242113 fra uke 16 til uke 156.
Legemiddel: JNJ-77242113
JNJ-77242113 vil bli administrert oralt.
Legemiddel: JNJ-77242113 Matchende placebo
JNJ-77242113 matchende placebo vil bli administrert oralt.
Legemiddel: Deucravacitinib Matching Placebo
Deucravacitinib-matchende placebo vil bli administrert oralt.
Aktiv komparator: Deucravacitinib
Deltakerne vil motta deucravacitinib fra uke 0 til uke 24 og matchende placebo for JNJ-77242113 fra uke 0 til uke 24 og JNJ-77242113 fra uke 24 til uke 156.
Legemiddel: JNJ-77242113
JNJ-77242113 vil bli administrert oralt.
Legemiddel: JNJ-77242113 Matchende placebo
JNJ-77242113 matchende placebo vil bli administrert oralt.
Legemiddel: Deucravacitinib
Deucravacitinib vil bli administrert oralt.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endring fra baseline i total PASI-score ved uke 16
Tidsramme: Utgangspunkt (Uke 0), Uke 16
Endring fra baseline i total PASI-poengsum ved uke 16 ble rapportert. PASI var et system som ble brukt for å vurdere og grader alvorlighetsgraden av psoriatiske lesjoner og deres respons på terapi. I PASI-systemet ble kroppen delt inn i 4 regioner: hodet, overkroppen, øvre ekstremiteter og nedre ekstremiteter. Hvert av disse områdene ble vurdert og poengsatt separat for erytem (rødme), indurasjon (fortykkelse) og skjell, som hver ble vurdert på en skala fra 0 til 4 (0=ingen, 1 = svak, 2 = moderat, 3 = alvorlig og 4 = svært alvorlig) og utbredelse fra 0 (indikerte ingen involvering) til 6 (90% - 100% involvering). PASI produserte en numerisk totalpoengsum som kunne variere fra 0 (ingen psoriasis) til 72 (maksimal psoriasis). Høyere poengsum indikerte større alvorlighetsgrad av psoriasis. Baseline ble definert som den nærmeste målingen tatt før eller på tidspunktet for første studielegemiddeladministrasjonsdato.
Utgangspunkt (Uke 0), Uke 16
Percentage of Participants Who Achieved PASI 100 Response at Week 16
Tidsramme: 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
Change From Baseline in Body Surface Area (BSA) at Week 16
Tidsramme: Baseline (Week 0), Week 16
A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percent Change From Baseline in PASI Total Score at Week 16
Tidsramme: Baseline (Week 0), Week 16
Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved IGA Score of 0 at Week 16
Tidsramme: 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 PASI 75 Response at Weeks 4 and 16
Tidsramme: 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
Tidsramme: 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 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
Tidsramme: Week 16
The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0
Tidsramme: 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
Tidsramme: 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 or 1 and >=2-Grade Improvement From Baseline at Weeks 16 and 24
Tidsramme: 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 an IGA Score of 0 at Weeks 16 and 24
Tidsramme: 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 PASI 75 Response at Weeks 16 and 24
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Change From Baseline in Total DLQI Score at Week 16
Tidsramme: 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
Tidsramme: 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 DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1
Tidsramme: 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 PSSD Symptoms Score of 0 at Week 24 Among Participants With a Baseline PSSD Symptom Score >0
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From Week 24 up to Week 160
From Week 24 up to Week 160
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Tidsramme: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Tidsramme: From Week 0 to Week 160
From Week 0 to Week 160

Samarbeidspartnere og etterforskere

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Sponsor

Janssen Research & Development, LLC

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. mars 2024

Primær fullføring (Faktiske)

15. november 2024

Studiet fullført (Antatt)

20. september 2027

Datoer for studieregistrering

Først innsendt

15. januar 2024

Først innsendt som oppfylte QC-kriteriene

15. januar 2024

Først lagt ut (Faktiske)

24. januar 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 77242113PSO3004 (Annen identifikator: Janssen Research & Development, LLC)
  • 2023 (U.S. NIH-stipend/kontrakt: GRAMMY Museum Foundation)
  • 2023-507039-39-00 (Registeridentifikator: EUCT number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Datadelingspolicyen til Janssen Pharmaceutical Companies of Johnson & Johnson er tilgjengelig på www.janssen.com/clinical-trials/transparency. Som nevnt på dette nettstedet, kan forespørsler om tilgang til studiedataene sendes gjennom Yale Open Data Access (YODA) prosjektnettsted på yoda.yale.edu

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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