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En langsiktig utvidelsesstudie av JNJ-77242113 hos deltakere med moderat til alvorlig plakkpsoriasis (FRONTIER 2)

29. mai 2026 oppdatert av: Janssen Research & Development, LLC

En fase 2b multisenterstudie, langsiktig utvidelse, doserende studie for å evaluere effektiviteten og sikkerheten til JNJ-77242113 for behandling av moderat til alvorlig plakkpsoriasis

Hensikten med denne studien er å evaluere langsiktig klinisk respons av JNJ-77242113-behandling hos deltakere med moderat til alvorlig plakkpsoriasis.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Befolkningen av mennesker som lever med moderat til alvorlig psoriasis er omtrent 3,5 milliarder, som for det meste behandles med aktuelle og konvensjonelle terapier. JNJ-77242113, undersøkelsesmedisin, retter seg mot immunresponsene i kroppen og huden som påvirker sykdommer, som psoriasis, og denne studien evaluerer JNJ-77242113 som alternativer for avanserte terapier ved moderat til alvorlig plakkpsoriasis. Dette er en langsiktig utvidelsesstudie av JNJ-77242113 i kvalifiserte deltakere som har fullført uke 16-besøket til den opprinnelige studien 77242113PSO2001. Den totale varigheten av denne studien vil være opptil 40 uker, som vil inkludere en 36-ukers behandlingsperiode og en 4-ukers sikkerhetsoppfølgingsperiode etter siste studieintervensjonsadministrasjon. Sikkerhet vil bli vurdert ved uønskede hendelser (AE), kliniske sikkerhetslaboratorievurderinger, elektrokardiogrammer (EKG), vitale tegn og fysiske undersøkelser.

Studietype

Intervensjonell

Registrering (Faktiske)

227

Fase

  • Fase 2

Kontakter og plasseringer

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

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.
  • Forente stater
    • California
      • Sacramento, California, Forente stater, 95815
        • Pacific Skin Institute
    • Florida
      • Ocala, Florida, Forente stater, 34470
        • Renstar Medical Research
      • Tampa, Florida, Forente stater, 33613
        • Forcare Clinical Research Inc
    • Illinois
      • Rolling Meadows, Illinois, Forente stater, 60008
        • Arlington Dermatology
    • Indiana
      • Plainfield, Indiana, Forente stater, 46168
        • Indiana Clinical Trial Center
    • Michigan
      • Fort Gratiot, Michigan, Forente stater, 48059
        • Hamzavi Dermatology
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89119
        • Vivida Dermatology
    • New Jersey
      • East Windsor, New Jersey, Forente stater, 08520
        • Windsor Dermatology, PC
    • Oregon
      • Portland, Oregon, Forente stater, 97210
        • Oregon Dermatology and Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh Department of Dermatology
    • Texas
      • Dallas, Texas, Forente stater, 75231
        • Modern Research Associates
      • Houston, Texas, Forente stater, 77004
        • Center for Clinical Studies
      • Webster, Texas, Forente stater, 77598
        • Center for Clinical Studies
    • Washington
      • Spokane, Washington, Forente stater, 99202
        • Premier Clinical Research
  • Frankrike
      • Le Mans, Frankrike, 72037
        • Centre Hospitalier Le Mans
      • Rouen, Frankrike, 76031
        • Hôpital Charles Nicolle
      • Toulon, Frankrike, 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
  • Spania
      • Barcelona, Spania, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Madrid, Spania, 28041
        • Hosp. Univ. 12 de Octubre
      • Valencia, Spania, 46940
        • Hosp. de Manises
      • Valencia, Spania, 46026
        • Hosp. Univ. I Politecni La Fe
  • Storbritannia
      • London, Storbritannia, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Southampton, Storbritannia, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • Sør -Korea
      • Busan, Sør -Korea, 49241
        • Pusan National University Hospital
      • Gyeonggi-do, Sør -Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Sør -Korea, 03080
        • Seoul National University Hospital
      • Seoul, Sør -Korea, 05030
        • Konkuk University Medical Center
      • Seoul, Sør -Korea, 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

Deltakelseskriterier

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

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Må ha fullført uke 16-besøket i protokoll 77242113PSO2001
  • Etter etterforskerens oppfatning kan det ha nytte av inkludering i denne langsiktige utvidelsesstudien (LTE).
  • Må godta å unngå langvarig soleksponering og unngå bruk av solarier eller andre ultrafiolette lyskilder under studiet
  • Må godta å avbryte alle aktuelle behandlinger som kan påvirke psoriasis eller psoriasis area severity index (PASI) eller etterforskerens globale vurdering (IGA) evaluering, bortsett fra ikke-medisinske mykgjørende sjampoer og salisylsyresjampoer, før første administrasjon av studieintervensjon
  • Godta å ikke motta et levende virus eller levende bakteriell vaksinasjon under studien, eller innen 4 uker etter siste administrering av studieintervensjon

Ekskluderingskriterier:

  • Ble permanent avbrutt fra studieintervensjon i protokoll 77242113PSO2001 av en eller annen grunn
  • Har mottatt biologisk terapi eller eksperimentell terapi siden fullføringen av den opprinnelige studien, 77242113PSO2001
  • Har mottatt levende virus- eller bakterievaksinasjon innen 12 uker før første administrasjon av studieintervensjon
  • Har mottatt bacille Calmette-Guerin (BCG) vaksine innen 12 måneder etter første administrasjon av studieintervensjon
  • Har for tiden hepatitt B overflateantigen (HBsAg) eller hepatitt C antistoff (anti-HCV) positivt, eller har annen klinisk aktiv leversykdom, eller tester positivt for HBsAg eller anti-HCV

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Gruppe 1: JNJ-77242113 Dose 1 én gang daglig (QD)
Deltakere som opprinnelig ble randomisert til JNJ-77242113 dose 1 QD i opprinnelsesstudie 77242113PSO2001 vil fortsette å motta JNJ-77242113 dose 1 QD fra uke 0 til uke 36 i denne studien.
Legemiddel: JNJ-77242113
JNJ-77242113 tablett vil bli administrert oralt.
Eksperimentell: Gruppe 2: JNJ-77242113 Dose 2 QD
Deltakere som opprinnelig ble randomisert til JNJ-77242113 dose 2 QD i opprinnelsesstudie 77242113PSO2001 vil fortsette å motta JNJ-77242113 dose 2 QD fra uke 0 til uke 36 i denne studien.
Legemiddel: JNJ-77242113
JNJ-77242113 tablett vil bli administrert oralt.
Eksperimentell: Gruppe 3: JNJ-77242113 Dose 3 QD
Deltakere som opprinnelig ble randomisert til JNJ-77242113 dose 3 QD i opprinnelsesstudie 77242113PSO2001 vil fortsette å motta JNJ-77242113 dose 3 QD fra uke 0 til uke 36 i denne studien.
Legemiddel: JNJ-77242113
JNJ-77242113 tablett vil bli administrert oralt.
Eksperimentell: Gruppe 4: JNJ-77242113 Dose 1 to ganger daglig (BID)
Deltakere som opprinnelig ble randomisert til JNJ-77242113 dose 1 BID i opprinnelsesstudie 77242113PSO2001 vil fortsette å motta JNJ-77242113 dose 1 BID fra uke 0 til uke 36 i denne studien.
Legemiddel: JNJ-77242113
JNJ-77242113 tablett vil bli administrert oralt.
Eksperimentell: Gruppe 5: JNJ-77242113 Dose 3 BID
Deltakere som opprinnelig ble randomisert til JNJ-77242113 dose 3 BID i opprinnelsesstudien 77242113PSO2001 vil fortsette å motta JNJ-77242113 dose 3 BID fra uke 0 til uke 36 i denne studien.
Legemiddel: JNJ-77242113
JNJ-77242113 tablett vil bli administrert oralt.
Eksperimentell: Gruppe 6: JNJ-77242113 Dose 3 QD
Deltakere som opprinnelig ble randomisert til placebo i opprinnelsesstudie 77242113PSO2001 vil motta JNJ-77242113 dose 3 QD fra uke 0 til uke 36 i denne studien.
Legemiddel: JNJ-77242113
JNJ-77242113 tablett vil bli administrert oralt.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Research & Development, LLC

Etterforskere

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

Publikasjoner og nyttige lenker

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

Generelle publikasjoner

Studierekorddatoer

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

Studer hoveddatoer

Studiestart (Faktiske)

10. juni 2022

Primær fullføring (Faktiske)

29. september 2023

Studiet fullført (Faktiske)

29. september 2023

Datoer for studieregistrering

Først innsendt

3. mai 2022

Først innsendt som oppfylte QC-kriteriene

3. mai 2022

Først lagt ut (Faktiske)

6. mai 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR109155
  • 2021-004320-16 (EudraCT-nummer)
  • 77242113PSO2002 (Annen identifikator: Janssen Research & Development, LLC)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere