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En langsigtet forlængelsesundersøgelse af JNJ-77242113 hos deltagere med moderat til svær plakpsoriasis (FRONTIER 2)

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

Et fase 2b multicenter, langsigtet forlængelse, dosisvarierende undersøgelse for at evaluere effektiviteten og sikkerheden af ​​JNJ-77242113 til behandling af moderat til svær plaque-psoriasis

Formålet med denne undersøgelse er at evaluere langsigtet klinisk respons af JNJ-77242113 behandling 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 ca. 3,5 milliarder, som for det meste behandles med topiske og konventionelle terapier. JNJ-77242113, forsøgslægemiddel, retter sig mod immunreaktioner i kroppen og huden, som påvirker sygdomme, såsom psoriasis, og denne undersøgelse evaluerer JNJ-77242113 som muligheder for avancerede terapier ved moderat til svær plakpsoriasis. Dette er en langsigtet forlængelsesundersøgelse af JNJ-77242113 i kvalificerede deltagere, som har gennemført uge 16-besøget i det oprindelige studie 77242113PSO2001. Den samlede varighed af denne undersøgelse vil være op til 40 uger, hvilket vil omfatte en 36-ugers behandlingsperiode og en 4-ugers sikkerhedsopfølgningsperiode efter den sidste undersøgelsesinterventionsadministration. Sikkerheden vil blive vurderet ved uønskede hændelser (AE'er), kliniske sikkerhedslaboratorievurderinger, elektrokardiogrammer (EKG'er), vitale tegn og fysiske undersøgelser.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

227

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dermatrials Research
      • Waterloo, Ontario, Canada, N2J 1C4
        • Alliance Clinical Trials
      • Windsor, Ontario, Canada, N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, Canada, H2H2B5
        • Innovaderm Research Inc.
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Southampton, Det Forenede Kongerige, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • Forenede Stater
    • California
      • Sacramento, California, Forenede Stater, 95815
        • Pacific Skin Institute
    • Florida
      • Ocala, Florida, Forenede Stater, 34470
        • Renstar Medical Research
      • Tampa, Florida, Forenede Stater, 33613
        • Forcare Clinical Research Inc
    • Illinois
      • Rolling Meadows, Illinois, Forenede Stater, 60008
        • Arlington Dermatology
    • Indiana
      • Plainfield, Indiana, Forenede Stater, 46168
        • Indiana Clinical Trial Center
    • Michigan
      • Fort Gratiot, Michigan, Forenede Stater, 48059
        • Hamzavi Dermatology
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Vivida Dermatology
    • New Jersey
      • East Windsor, New Jersey, Forenede Stater, 08520
        • Windsor Dermatology, PC
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Oregon Dermatology and Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Department of Dermatology
    • Texas
      • Dallas, Texas, Forenede Stater, 75231
        • Modern Research Associates
      • Houston, Texas, Forenede Stater, 77004
        • Center for Clinical Studies
      • Webster, Texas, Forenede Stater, 77598
        • Center for Clinical Studies
    • Washington
      • Spokane, Washington, Forenede Stater, 99202
        • Premier Clinical Research
  • Frankrig
      • Le Mans, Frankrig, 72037
        • Centre Hospitalier Le Mans
      • Rouen, Frankrig, 76031
        • Hôpital Charles Nicolle
      • Toulon, Frankrig, 83800
        • Hia Sainte Anne
  • Japan
      • Obihiro-shi, Japan, 080-0013
        • Takagi Dermatological Clinic
      • Sakai, Japan, 593 8324
        • Kume Clinic
      • Sapporo, Japan, 060-0063
        • Sapporo Skin Clinic
      • Shizuoka, Japan, 420-8527
        • Shizuoka General Hospital
      • Takaoka, Japan, 933-0871
        • Shirasaki dermatology clinic
      • Toyama, Japan, 930 8550
        • Toyama Prefectural Central Hospital
      • Yokohama, Japan, 221 0825
        • Nomura Dermatology Clinic
  • Polen
      • Bialystok, Polen, 15-351
        • Nzoz Zdrowie Osteo-Medic
      • Lodz, Polen, 90-265
        • Dermed Centrum Medyczne Sp z o o
      • Osielsko, Polen, 86031
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
      • Warsaw, Polen, 02-953
        • Klinika Ambroziak Estederm Sp. z o.o
      • Wroclaw, Polen, 51-685
        • Wro Medica
  • Spanien
      • Barcelona, Spanien, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Madrid, Spanien, 28041
        • Hosp. Univ. 12 de Octubre
      • Valencia, Spanien, 46940
        • Hosp. de Manises
      • Valencia, Spanien, 46026
        • Hosp. Univ. I Politecni La Fe
  • Sydkorea
      • Busan, Sydkorea, 49241
        • Pusan National University Hospital
      • Gyeonggi-do, Sydkorea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Sydkorea, 03080
        • Seoul National University Hospital
      • Seoul, Sydkorea, 05030
        • Konkuk University Medical Center
      • Seoul, Sydkorea, 102-1703
        • KyungHee University Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 83342
        • Chang Gung Memorial Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Chang-Gung Memorial Hospital, LinKou Branch
  • Tyskland
      • Bad Bentheim, Tyskland, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Tyskland, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Berlin, Tyskland, 13627
        • CRS Clinical Research Services Berlin GMBH
      • Bochum, Tyskland, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, Tyskland, 64283
        • Rosenpark Research GmbH
      • Frankfurt am Main, Tyskland, 60590
        • Universitätsklinikum Frankfurt
      • Friedrichshafen, Tyskland, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Hamburg, Tyskland, 22391
        • MensingDerma Research GmbH
      • Heidelberg, Tyskland, 69120
        • Universitaetsklinikum Heidelberg
      • Kiel, Tyskland, 24105
        • Universitatsklinikum Schleswig Holstein Kiel
      • Mahlow, Tyskland, 15831
        • Gemeinschaftspraxis Scholz/Sebastian/Schilling
      • Witten, Tyskland, 58453
        • Hautarztpraxis

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Skal have gennemført besøget i uge 16 i protokol 77242113PSO2001
  • Efter investigators mening kan den drage fordel af inklusion i denne langsigtede forlængelse (LTE) undersøgelse
  • Skal acceptere at undgå langvarig soleksponering og undgå brug af solariekabiner eller andre ultraviolette lyskilder under undersøgelsen
  • Skal acceptere at afbryde alle topiske behandlinger, der kan påvirke psoriasis eller psoriasis area severity index (PASI) eller investigator's global assessment (IGA) evaluering, bortset fra ikke-medicinske blødgørende shampoo og salicylsyreshampooer, før første administration af undersøgelsesintervention
  • Accepter ikke at modtage en levende virus eller levende bakteriel vaccination under undersøgelsen eller inden for 4 uger efter den sidste administration af undersøgelsesintervention

Ekskluderingskriterier:

  • Blev permanent afbrudt fra undersøgelsesintervention i protokol 77242113PSO2001 af en eller anden grund
  • Har modtaget biologisk terapi eller eksperimentel terapi siden afslutningen af ​​den oprindelige undersøgelse, 77242113PSO2001
  • Har modtaget levende virus eller bakteriel vaccination inden for 12 uger før den første administration af undersøgelsesintervention
  • Har modtaget bacille Calmette-Guerin (BCG) vaccinen inden for 12 måneder efter den første administration af undersøgelsesintervention
  • Har i øjeblikket hepatitis B overfladeantigen (HBsAg) eller hepatitis C antistof (anti-HCV) positivt, eller har anden klinisk aktiv leversygdom, eller tester positivt for HBsAg eller anti-HCV

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gruppe 1: JNJ-77242113 Dosis 1 én gang dagligt (QD)
Deltagere, der oprindeligt var randomiseret til JNJ-77242113 dosis 1 QD i det oprindelige studie 77242113PSO2001, vil fortsat modtage JNJ-77242113 dosis 1 QD fra uge 0 til og med uge 36 i denne undersøgelse.
Medicin: JNJ-77242113
JNJ-77242113 tablet vil blive indgivet oralt.
Eksperimentel: Gruppe 2: JNJ-77242113 Dosis 2 QD
Deltagere, der oprindeligt var randomiseret til JNJ-77242113 Dosis 2 QD i det oprindelige studie 77242113PSO2001, vil fortsætte med at modtage JNJ-77242113 Dosis 2 QD fra uge 0 til og med uge 36 i denne undersøgelse.
Medicin: JNJ-77242113
JNJ-77242113 tablet vil blive indgivet oralt.
Eksperimentel: Gruppe 3: JNJ-77242113 Dosis 3 QD
Deltagere, der oprindeligt var randomiseret til JNJ-77242113 dosis 3 QD i det oprindelige studie 77242113PSO2001, vil fortsætte med at modtage JNJ-77242113 dosis 3 QD fra uge 0 til og med uge 36 i denne undersøgelse.
Medicin: JNJ-77242113
JNJ-77242113 tablet vil blive indgivet oralt.
Eksperimentel: Gruppe 4: JNJ-77242113 Dosis 1 to gange dagligt (BID)
Deltagere, der oprindeligt var randomiseret til JNJ-77242113 dosis 1 BID i det oprindelige studie 77242113PSO2001, vil fortsat modtage JNJ-77242113 dosis 1 BID fra uge 0 til og med uge 36 i denne undersøgelse.
Medicin: JNJ-77242113
JNJ-77242113 tablet vil blive indgivet oralt.
Eksperimentel: Gruppe 5: JNJ-77242113 Dosis 3 BID
Deltagere, der oprindeligt var randomiseret til JNJ-77242113 dosis 3 BID i det oprindelige studie 77242113PSO2001, vil fortsat modtage JNJ-77242113 dosis 3 BID fra uge 0 til og med uge 36 i denne undersøgelse.
Medicin: JNJ-77242113
JNJ-77242113 tablet vil blive indgivet oralt.
Eksperimentel: Gruppe 6: JNJ-77242113 Dosis 3 QD
Deltagere, der oprindeligt blev randomiseret til placebo i det oprindelige studie 77242113PSO2001, vil modtage JNJ-77242113 dosis 3 QD fra uge 0 til og med uge 36 i denne undersøgelse.
Medicin: JNJ-77242113
JNJ-77242113 tablet vil blive indgivet oralt.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Psoriasis Area Severity Index Score (PASI-75) at LTE Week 36
Tidsramme: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of participants who achieved >=75% improvement from baseline in PASI score at LTE Week 36 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI-90) at LTE Week 36
Tidsramme: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of participants who achieved >=90% improvement from baseline in PASI score at LTE Week 36 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI Score (PASI-100) at LTE Week 36
Tidsramme: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of participants who achieved 100% improvement from baseline in PASI score at LTE Week 36 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: 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 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range on a scale of 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in PASI Total Score at LTE Week 36
Tidsramme: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change from baseline in PASI total score at LTE Week 36 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 first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at LTE Week 36
Tidsramme: At LTE Week 36 (52 weeks from originating study baseline)
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.
At LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at LTE Week 36
Tidsramme: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change from baseline in PSSD symptoms scores at LTE Week 36 was reported. PSSD was a patient-reported outcome (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD: 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 scales for severity. Items were averaged on the daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales were answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0=least severe and 100=most severe. Higher score indicated more severe disease. Baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in PSSD Signs Score at LTE Week 36
Tidsramme: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change from baseline in PSSD sign scores at LTE Week 36 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 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. Items were averaged on the daily sign score when at least 3 items (>=50 percentage of 6 items) on these scales were answered. The average value was converted into 0-100 scoring, such that sign score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved PSSD Symptoms Score Equal (=) 0 at LTE Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Symptoms Score >=1
Tidsramme: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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. Items were averaged on the daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Signs Score >=1
Tidsramme: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 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. Items were averaged on the daily sign score when at least 3 items (>=50 percentage of 6 items) on these scales are answered. The average value is converted into 0-100 scoring, such that sign score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Tidsramme: From LTE Week 0 up to LTE Week 40
An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any AE that occurred after receiving the treatment in originating study (77242113PSO2001). TEAEs and TESAEs that occurred during this study are reported.
From LTE Week 0 up to LTE Week 40

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

10. juni 2022

Primær færdiggørelse (Faktiske)

29. september 2023

Studieafslutning (Faktiske)

29. september 2023

Datoer for studieregistrering

Først indsendt

3. maj 2022

Først indsendt, der opfyldte QC-kriterier

3. maj 2022

Først opslået (Faktiske)

6. maj 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR109155
  • 2021-004320-16 (EudraCT nummer)
  • 77242113PSO2002 (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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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