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En undersøgelse af JNJ-77242113 til behandling af moderat til svær plakpsoriasis (SUMMIT)

1. maj 2026 opdateret af: Janssen Research & Development, LLC

En fase 2a multicenter, randomiseret, dobbeltblind, placebokontrolleret undersøgelse til evaluering af effektiviteten, sikkerheden og tolerabiliteten af ​​en oral tabletformulering af JNJ-77242113 til behandling af moderat til svær plaque-psoriasis

Formålet med undersøgelsen er at evaluere effektiviteten af ​​en oral tabletformulering af JNJ-77242113 sammenlignet med placebo hos deltagere med moderat til svær plaque psoriasis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Befolkningen af ​​mennesker, der lever med moderat til svær psoriasis, er cirka 3,5 milliarder, som for det meste behandles med topiske og konventionelle terapier. JNJ-77242113, forsøgslægemiddel, retter sig mod immunreaktionerne i kroppen og huden, som påvirker sygdomme, såsom psoriasis og psoriasisgigt, og denne undersøgelse evaluerer JNJ-77242113 som muligheder for avancerede terapier ved moderat til svær plakpsoriasis. Hypotesen for denne undersøgelse er, at en oral tabletformulering af JNJ-77242113 vil resultere i overlegen effektivitet sammenlignet med placebo som bestemt af procentdelen af ​​deltagere, der opnår Psoriasis Area and Severity Index (PASI) 75 (større end eller lig med [>=] 75 procent [%] forbedring i PASI) (PASI 75) respons i uge 16. Den samlede varighed af denne undersøgelse er op til 24 uger, hvilket inkluderer en screeningsperiode på mindre end eller lig med (

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute Inc
    • Ontario
      • London, Ontario, Canada, N6A 3H7
        • The Guenther Dermatology Research Centre
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc.
      • Mississauga, Ontario, Canada, L4Y 4C5
        • DermEdge Research
      • Toronto, Ontario, Canada, M3H 5Y8
        • Toronto Research Centre
  • Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater, 90212
        • Stoll Dermatology
    • Illinois
      • Skokie, Illinois, Forenede Stater, 60077
        • NorthShore University Healthsystem
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66210
        • Epiphany Dermatology of Kansas, LLC
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40241
        • Dermatology Specialists
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20850
        • Lawrence J Green MD LLC
    • Massachusetts
      • Beverly, Massachusetts, Forenede Stater, 01915
        • ActivMed Practices and Research
    • New Hampshire
      • Portsmouth, New Hampshire, Forenede Stater, 03801
        • ActivMed Practices and Research
    • New Jersey
      • East Windsor, New Jersey, Forenede Stater, 08520
        • Windsor Dermatology, PC
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73118
        • Unity Clinical Research
    • Pennsylvania
      • Exton, Pennsylvania, Forenede Stater, 19341
        • The Pennsylvania Centre for Dermatology, LLC
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57702
        • Health Concepts
    • Texas
      • Arlington, Texas, Forenede Stater, 76011
        • Arlington Center for Dermatology
  • Frankrig
      • Brest, Frankrig, 29200
        • CHRU Brest - Hopital Morvan
      • La Tronche, Frankrig, 38700
        • CHU de Grenoble Hopital Albert Michallon
      • Nice, Frankrig, 06200
        • CHU de Nice Hopital de l Archet
      • Reims, Frankrig, 51100
        • Polyclinique de Courlancy
  • Polen
      • Bialystok, Polen, 15 375
        • Specderm Poznanska sp j
      • Krakow, Polen, 30 002
        • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
      • Lodz, Polen, 90-338
        • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
  • Spanien
      • Barakaldo, Spanien, 48902
        • Hosp. Univ. de Cruces
      • Granada, Spanien, 18016
        • Hosp. Univ. San Cecilio
      • Seville, Spanien, 41009
        • Hosp. Virgen Macarena
  • Tyskland
      • Bramsche, Tyskland, 49565
        • Hautarztpraxis
      • Dresden, Tyskland, 01307
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Düsseldorf, Tyskland, 40212
        • Privatpraxis Dr. Hilton & Partner
      • Frankfurt am Main, Tyskland, 60590
        • Universitatsklinikum Frankfurt
      • Lübeck, Tyskland, 23538
        • Universitatsklinikum Schleswig Holstein Campus Lubeck
      • Münster, Tyskland, 48149
        • Universitätsklinikum Münster
      • Rostock, Tyskland, 18057
        • Universitaetsmedizin Rostock

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Deltageren har en diagnose af plaque psoriasis, med eller uden psoriasisgigt, i mindst 26 uger før den første administration af undersøgelsesintervention
  • Deltageren har et samlet kropsoverfladeareal (BSA) større end eller lig med (>=) 10 procent (%) ved screening og baseline
  • Deltageren har et samlet Psoriasis Area and Severity Index (PASI) >= 12 ved screening og baseline
  • Deltageren har en samlet Investigator's Global Assessment (IGA) >= 3 ved screening og baseline
  • Deltager være kandidat til fototerapi eller systemisk behandling for plaque psoriasis

Ekskluderingskriterier:

  • Deltageren har en ikke-plaque form for psoriasis (for eksempel erytrodermisk, guttat eller pustulær)
  • Deltageren har aktuel lægemiddelinduceret psoriasis (f.eks. en ny debut af psoriasis eller en forværring af psoriasis fra betablokkere, calciumkanalblokkere eller lithium)
  • Deltagerne har tidligere modtaget ethvert andet terapeutisk middel, der er direkte målrettet mod interleukin 23 (herunder, men ikke begrænset til, guselkumab, tildrakizumab eller risankizumab)
  • Deltageren har modtaget ethvert terapeutisk middel direkte målrettet mod interleukin 17 (IL-17), interleukin 17-receptor (IL-17R) eller interleukin 12/23 (IL-12/23) (herunder, men ikke begrænset til, secukinumab, ixekizumab, brodalumab eller ustekinumab) eller har modtaget biologisk behandling rettet mod tumornekrosefaktor (TNF) (herunder, men ikke begrænset til adalimumab, infliximab eller etanercept) inden for 12 uger eller 5 halveringstider, alt efter hvad der er længst, efter den første administration af undersøgelsesintervention
  • Deltageren har modtaget protonpumpehæmmere (herunder, men ikke begrænset til, omeprazol, esomeprazol, lansoprazol, rabeprazol, pantoprazol, dexlansoprazol eller zegerid) inden for 1 uge efter første indgivelse af undersøgelsesintervention

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gruppe 1: JNJ-77242113 Dosis 1
Deltagerne vil modtage JNJ-77242113 dosis 1 som tabletter med forsinket frigivelse oralt én gang dagligt fra uge 0 til og med uge 16.
Medicin: JNJ-77242113
JNJ-77242113 vil blive indgivet oralt som tabletter med forsinket frigivelse.
Andre navne:
  • PN-21235,
  • PN-235
Eksperimentel: Gruppe 2: JNJ-77242113 Dosis 2
Deltagerne vil modtage JNJ-77242113 dosis 2 som tabletter med forsinket frigivelse oralt én gang dagligt fra uge 0 til og med uge 16.
Medicin: JNJ-77242113
JNJ-77242113 vil blive indgivet oralt som tabletter med forsinket frigivelse.
Andre navne:
  • PN-21235,
  • PN-235
Placebo komparator: Gruppe 3: Placebo
Deltagerne vil modtage oral dosis af matchende placebo én gang dagligt fra uge 0 til og med uge 16.
Medicin: Placebo
Matchende placebo vil blive indgivet oralt som tabletter med forsinket frigivelse.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentages of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 16
Tidsramme: Baseline (Week 0), Week 16
Percentage of participants who achieved PASI-75 score (greater than or equal to [>=] 75% improvement from baseline in PASI) at Week 16 were 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline i PASI total score i uge 16
Tidsramme: Baseline (uge 0), uge 16
Ændringen fra baseline i den samlede PASI-score i uge 16 blev rapporteret. PASI var et system, der blev brugt til at vurdere og graduere sværhedsgraden af psoriatiske læsioner og deres respons på behandling. I PASI-systemet blev kroppen opdelt i 4 regioner: hovedet, overkroppen, overekstremiteterne og underekstremiteterne. Hver af disse områder blev vurderet og scoreret separat for erytem, induration og skældannelse, som hver blev vurderet på en skala fra 0 til 4 (0=ingen, 1=svag, 2=moderat, 3=svær og 4=meget svær) og omfanget af involvering fra 0 (angav ingen involvering) til 6 (90% - 100% involvering). PASI producerede en numerisk totalscore, der kunne variere fra 0 (ingen psoriasis) til 72 (maksimal psoriasis). Højere score indikerede større sværhedsgrad af psoriasis. Baseline blev defineret som den tætteste måling taget før eller på tidspunktet for den første administrationsdato af undersøgelsesmedicinen.
Baseline (uge 0), uge 16
Percentages of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI 90) Score at Week 16
Tidsramme: Baseline (Week 0), Week 16
Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 16 were 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
Percentages of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI 100) Score at Week 16
Tidsramme: Baseline (Week 0), Week 16
Percentages of participants who achieved PASI 100- score (100% improvement from baseline in PASI) at Week 16 were 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 an Investigator Global Assessment (IGA) Score of Cleared (0) or Minimal (1) 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 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; 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
Percentages of Participants Who Achieved an IGA Score of Cleared (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 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; 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
Percent Change From Baseline in Psoriasis-Affected Body Surface Area (BSA) at Week 16
Tidsramme: Baseline (Week 0), Week 16
Percent change from baseline in psoriasis-affected BSA at Week 16 was reported. 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 handprint 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 measurement was defined as the closest measurement taken prior to or at the time of the first study intervention administration date.
Baseline (Week 0), Week 16
Number of Participants With 1 or More Treatment-emergent Adverse Events (TEAEs)
Tidsramme: From Week 0 through Week 20
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE was defined as any adverse event that occurred at or after the initial administration of study intervention. Data included all TEAEs (both serious and non-serious).
From Week 0 through Week 20
Number of Participants With Serious TEAEs
Tidsramme: From Week 0 through Week 20
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death, is life threatening, require inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. TEAE was defined as any adverse event that occurs at or after the initial administration of study intervention.
From Week 0 through Week 20

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Efterforskere

  • Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. juni 2022

Primær færdiggørelse (Faktiske)

23. marts 2023

Studieafslutning (Faktiske)

10. april 2023

Datoer for studieregistrering

Først indsendt

27. april 2022

Først indsendt, der opfyldte QC-kriterier

27. april 2022

Først opslået (Faktiske)

3. maj 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR109193
  • 2021-005987-23 (EudraCT nummer)
  • 77242113PSO2003 (Anden identifikator: Janssen Research & Development, LLC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Datadelingspolitikken for Janssen Pharmaceutical Companies of Johnson & Johnson er tilgængelig på www.janssen.com/clinical-trials/transparency. Som nævnt på dette websted kan anmodninger om adgang til undersøgelsesdataene indsendes gennem Yale Open Data Access (YODA) projektwebsted på yoda.yale.edu

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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