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Een onderzoek naar JNJ-77242113 voor de behandeling van deelnemers met matige tot ernstige plaque-psoriasis (ICONIC-ADVANCE 2)

27 augustus 2026 bijgewerkt door: Janssen Research & Development, LLC

Een fase 3 multicenter, gerandomiseerde, dubbelblinde, placebogecontroleerde en deucravacitinib-actieve comparator-gecontroleerde studie om de werkzaamheid en veiligheid van JNJ-77242113 te evalueren voor de behandeling van deelnemers met matige tot ernstige plaque psoriasis

Het doel van het onderzoek is om te evalueren hoe effectief JNJ-77242113 is bij deelnemers met matige tot ernstige plaque psoriasis vergeleken met placebo en deucravacitinib.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

731

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
      • Benowa, Australië, 4217
        • The Skin Centre
      • Clayton, Australië, 3168
        • Monash Medical Centre
      • Kogarah, Australië, 2217
        • Premier Specialists
      • Melbourne, Australië, 3004
        • The Alfred Hospital
      • Mitcham, Australië, 3132
        • ISHI dermatology
      • Parkville, Australië, 3050
        • Royal Melbourne Hospital
  • Brazilië
      • Botucatu, Brazilië, 18618-686
        • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
      • Brasília, Brazilië, 72145-450
        • Chronos Clinica Medica Ltda
      • Ribeirão Preto, Brazilië, 14051140
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
      • São José do Rio Preto, Brazilië, 15090-000
        • Funfarme Sjrp
      • São Paulo, Brazilië, 05403 900
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
      • São Paulo, Brazilië, 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
  • Duitsland
      • Augsburg, Duitsland, 86150
        • Hautarztpraxis Dr. Mihaescu
      • Bad Bentheim, Duitsland, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Duitsland, 13627
        • CRS Clinical Research Services Berlin GMBH
      • Bochum, Duitsland, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, Duitsland, 64283
        • Klinikum Darmstadt GmbH - Hautklinik
      • Dresden, Duitsland, 01307
        • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
      • Dülmen, Duitsland, 48249
        • Hautzentrum Dulmen
      • Düsseldorf, Duitsland, 40212
        • Privatpraxis Dr. Hilton & Partner
      • Friedrichshafen, Duitsland, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Hamburg, Duitsland, 20095
        • Eurofins bioskin GmbH
      • Heidelberg, Duitsland, 69120
        • Universitaetsklinikum Heidelberg
      • Mahlow, Duitsland, 15831
        • Hautarztpraxis
      • Mainz, Duitsland, 55131
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
      • Merzig, Duitsland, 66663
        • Hautmedizin Saar Science Hms GmbH
      • Münster, Duitsland, 48149
        • Universitaetsklinikum Muenster
      • Oldenburg, Duitsland, 26133
        • Klinikum Oldenburg
      • Witten, Duitsland, 58453
        • Hautarztpraxis 1
      • Wuppertal, Duitsland, 42287
        • CentroDerm GmbH
  • Hongarije
      • Budapest, Hongarije, 1152
        • Uno Medical Trials Ltd.
      • Gyula, Hongarije, 5700
        • Synexus Magyarorszag Kft
      • Gyöngyös, Hongarije, 3200
        • Bugat Pal Korhaz
      • Kecskemét, Hongarije, 6000
        • Bacs Kiskun Varmegyei Oktatokorhaz
      • Zalaegerszeg, Hongarije, H-8900
        • Synexus Magyarorszag Kft 1
  • 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
  • Roemenië
      • Cluj-Napoca, Roemenië, 400105
        • Cabinet Medical Dermato-Venerologie
      • Craiova, Roemenië, 200541
        • Centrul Medical Vitaplus
      • Craiova, Roemenië, 200642
        • Spitalul Clinic Județean de Urgență
      • Iași, Roemenië, 700381
        • Sc Iasiprest Srl
      • Oradea, Roemenië, 410167
        • Spitalul Clinic Judetean De Urgenta Bihor
      • Timișoara, Roemenië, 300757
        • New Derm Clinic
      • Târgu Mureş, Roemenië, 540342
        • Spitalul Clinic Judetean Mures
  • Spanje
      • Alcorcón, Spanje, 28922
        • Hosp. Univ. Fundacion Alcorcon
      • Badalona, Spanje, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spanje, 08036
        • Hosp Clinic de Barcelona
      • Manises, Spanje, 46940
        • Hosp. de Manises
      • Salamanca, Spanje, 37007
        • Hosp Clinico Univ de Salamanca
      • Santiago de Compostela, Spanje, 15702
        • Clinica Gaias
      • Santiago de Compostela, Spanje, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Spanje, 41009
        • Hosp. Virgen Macarena
      • Seville, Spanje, 41014
        • Hosp. Ntra. Sra. de Valme
      • Villajoyosa, Spanje, 03570
        • Hosp. de La Marina Baixa
      • Zaragoza, Spanje, 50009
        • Hosp. Clinico Univ. Lozano Blesa
  • 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
  • Verenigde Staten
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85032
        • Alliance Dermatology and MOHS Center P C
    • California
      • Encinitas, California, Verenigde Staten, 92024
        • California Dermatology & Clinical Research Institute
      • Encino, California, Verenigde Staten, 91436
        • T Joseph Raoof Md Inc
      • Fresno, California, Verenigde Staten, 93701
        • Ucsf Fresno
      • Los Angeles, California, Verenigde Staten, 90056
        • Wallace Medical Group, Inc
      • Los Angeles, California, Verenigde Staten, 90024
        • University of California Los Angeles - Division of Dermatology
      • Oceanside, California, Verenigde Staten, 92056
        • Dermatologist Medical Group of North County, Inc.
    • Florida
      • Miami, Florida, Verenigde Staten, 33155
        • Bioclinical Research Alliance Inc.
      • Miami, Florida, Verenigde Staten, 33133
        • Miami Dermatology And Laser Institute
      • Tampa, Florida, Verenigde Staten, 33613
        • Forcare Clinical Research Inc
    • Georgia
      • Douglasville, Georgia, Verenigde Staten, 30135
        • Southeast Dermatology Specialists
    • Illinois
      • Rolling Meadows, Illinois, Verenigde Staten, 60008
        • Arlington Dermatology
    • Kentucky
      • Louisville, Kentucky, Verenigde Staten, 40217
        • Skin Sciences, PLLC
      • Owensboro, Kentucky, Verenigde Staten, 42301
        • Qualmedica Research
    • Maryland
      • Rockville, Maryland, Verenigde Staten, 20850
        • DermAssociates, PC
    • Massachusetts
      • Brighton, Massachusetts, Verenigde Staten, 02135
        • Metro Boston Clinical Partners
      • Methuen, Massachusetts, Verenigde Staten, 01844
        • ActivMed Practices and Research
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • University of Michigan
      • Bay City, Michigan, Verenigde Staten, 48706
        • Great Lakes Research Group
      • Caledonia, Michigan, Verenigde Staten, 49316
        • The Derm Institute of West Michigan
      • Canton, Michigan, Verenigde Staten, 48187
        • Hamzavi Dermatology
      • Troy, Michigan, Verenigde Staten, 48084
        • Somerset Skin Centre
    • Missouri
      • Kirksville, Missouri, Verenigde Staten, 63501
        • Cleaver Dermatology
    • Ohio
      • Bexley, Ohio, Verenigde Staten, 43209
        • Bexley Dermatology Research
    • Oklahoma
      • Tulsa, Oklahoma, Verenigde Staten, 74137
        • Essential Medical Research
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97210-2996
        • Oregon Dermatology & Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19103
        • Paddington Testing Co, Inc.
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29407
        • Clinical Research Center of the Carolinas LLC
      • Greenville, South Carolina, Verenigde Staten, 29615
        • Palmetto Clinical Trial Services, LLC
    • Texas
      • Arlington, Texas, Verenigde Staten, 76011
        • Arlington Research Center, inc.
      • Dallas, Texas, Verenigde Staten, 75390
        • UT Southwestern Medical Center
      • San Antonio, Texas, Verenigde Staten, 78229
        • Dermatology Clinical Research Center of San Antonio
      • Webster, Texas, Verenigde Staten, 77598
        • Center for Clinical Studies
    • Utah
      • Bountiful, Utah, Verenigde Staten, 84010
        • Cope Family Medicine - Ogden Clinic
      • Springville, Utah, Verenigde Staten, 84663
        • Springville Dermatology CCT Research
      • West Valley City, Utah, Verenigde Staten, 84120
        • Kalo Clinical Research
    • Virginia
      • Norfolk, Virginia, Verenigde Staten, 23502
        • Virginia Dermatology Skin Cancer Center Pllc
  • Zuid -Korea
      • Ansan-si, Zuid -Korea, 15355
        • Korea University Ansan Hospital
      • Anyang-si, Zuid -Korea, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon-si, Zuid -Korea, 14647
        • The Catholic University of Korea Bucheon St Mary s Hospital
      • Gwangju, Zuid -Korea, 61453
        • Chosun University Hospital
      • Seongnam, Zuid -Korea, 13496
        • CHA Bundang Medical Center, CHA University
      • Seoul, Zuid -Korea, 05505
        • Asan Medical Center
      • Seoul, Zuid -Korea, 8308
        • Korea University Guro Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

  • Diagnose van plaque psoriasis, met of zonder artritis psoriatica (PsA), gedurende ten minste 26 weken voorafgaand aan de eerste toediening van de onderzoeksinterventie
  • Totaal lichaamsoppervlak (BSA) groter dan of gelijk aan (>=)10 procent (%) bij screening en baseline
  • Totaal psoriasisgebied en ernstindex (PASI) >=12 bij screening en baseline
  • Totale globale beoordeling door onderzoeker (IGA) >=3 bij screening en baseline
  • Kandidaat voor fototherapie of systemische behandeling voor plaque psoriasis

Uitsluitingscriteria:

  • Niet-plaque vorm van psoriasis (bijvoorbeeld erytrodermisch, guttaat of pustulair)
  • Huidige door geneesmiddelen geïnduceerde psoriasis (bijvoorbeeld een nieuw begin van psoriasis of een verergering van psoriasis door bètablokkers, calciumantagonisten of lithium)
  • Een huidige diagnose of tekenen of symptomen van ernstige, progressieve of ongecontroleerde nier-, lever-, hart-, vasculaire, long-, gastro-intestinale, endocriene, neurologische, hematologische, reumatologische, psychiatrische of metabolische stoornissen
  • Bekende allergieën, overgevoeligheid of intolerantie voor JNJ-77242113 of de hulpstoffen ervan
  • Grote chirurgische ingreep (waarbij bijvoorbeeld algemene anesthesie nodig is) binnen 8 weken vóór de screening, of niet volledig hersteld is van de chirurgische ingreep, of er is een chirurgische ingreep gepland gedurende de tijd dat de deelnemer naar verwachting aan het onderzoek zal deelnemen

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: JNJ-77242113
Deelnemers ontvangen JNJ-77242113 van week 0 tot en met week 156 en deucravacitinib, een overeenkomende placebo van week 0 tot en met week 24.
Geneesmiddel: JNJ-77242113
JNJ-77242113 zal oraal worden toegediend.
Geneesmiddel: Deucravacitinib Matchend Placebo
Deucravacitinib-matching-placebo zal oraal worden toegediend.
Placebo-vergelijker: Placebo
Deelnemers krijgen van week 0 tot en met week 16 een bijpassende placebo voor JNJ-77242113, een bijpassende placebo voor deucravacitinib van week 0 tot en met week 24 en JNJ-77242113 van week 16 tot en met week 156.
Geneesmiddel: JNJ-77242113
JNJ-77242113 zal oraal worden toegediend.
Geneesmiddel: JNJ-77242113 Overeenkomende placebo
JNJ-77242113 overeenkomende placebo zal oraal worden toegediend.
Geneesmiddel: Deucravacitinib Matchend Placebo
Deucravacitinib-matching-placebo zal oraal worden toegediend.
Actieve vergelijker: Deucravacitinib
Deelnemers krijgen deucravacitinib van week 0 tot en met week 24 en een bijpassende placebo voor JNJ-77242113 van week 0 tot en met week 24 en JNJ-77242113 van week 24 tot en met week 156.
Geneesmiddel: JNJ-77242113
JNJ-77242113 zal oraal worden toegediend.
Geneesmiddel: JNJ-77242113 Overeenkomende placebo
JNJ-77242113 overeenkomende placebo zal oraal worden toegediend.
Geneesmiddel: Deucravacitinib
Deucravacitinib zal oraal worden toegediend.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Verandering ten opzichte van baseline in totale PASI-score na 16 weken
Tijdsspanne: Baseline (Week 0), Week 16
De verandering ten opzichte van de baseline in de totale PASI-score na 16 weken werd gerapporteerd. De PASI was een systeem dat werd gebruikt om de ernst van psoriatische laesies en hun respons op therapie te beoordelen en te classificeren. In het PASI-systeem werd het lichaam verdeeld in 4 regio's: het hoofd, de romp, de bovenste extremiteiten en de onderste extremiteiten. Elk van deze gebieden werd afzonderlijk beoordeeld en gescoord voor erytheem, induratie en schilfering, die elk werden beoordeeld op een schaal van 0 tot 4 (0=geen, 1=licht, 2=matig, 3=ernstig en 4=zeer ernstig) en de mate van betrokkenheid van 0 (geen betrokkenheid) tot 6 (90% - 100% betrokkenheid). De PASI produceerde een numerieke totale score die kon variëren van 0 (geen psoriasis) tot 72 (maximale psoriasis). Een hogere score duidde op een grotere ernst van psoriasis. De baseline werd gedefinieerd als de meest recente meting die vóór of op het tijdstip van de eerste toediening van het studiegeneesmiddel werd uitgevoerd.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved PASI 100 Response at Week 16
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: From Week 24 up to Week 160
From Week 24 up to Week 160
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Tijdsspanne: From Week 0 to Week 160
From Week 0 to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Tijdsspanne: From Week 0 to Week 160
From Week 0 to Week 160

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Sponsor

Janssen Research & Development, LLC

Onderzoekers

  • Studie directeur: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC

Publicaties en nuttige links

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Studie record data

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Bestudeer belangrijke data

Studie start (Werkelijk)

9 maart 2024

Primaire voltooiing (Werkelijk)

15 november 2024

Studie voltooiing (Geschat)

20 september 2027

Studieregistratiedata

Eerst ingediend

15 januari 2024

Eerst ingediend dat voldeed aan de QC-criteria

15 januari 2024

Eerst geplaatst (Werkelijk)

24 januari 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 77242113PSO3004 (Andere identificatie: Janssen Research & Development, LLC)
  • 2023 (Subsidie/contract van de Amerikaanse NIH: GRAMMY Museum Foundation)
  • 2023-507039-39-00 (Register-ID: EUCT number)

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Beschrijving IPD-plan

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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