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En 32-ukers studie for å evaluere effektiviteten og sikkerheten til Tralokinumab hos personer med moderat til alvorlig atopisk håndeksem som er kandidater for systemisk terapi (ADHAND)

30. juli 2026 oppdatert av: LEO Pharma

En fase 3b, intervensjonell, adaptiv, klinisk studie for å evaluere effektiviteten og sikkerheten til Tralokinumab 300 mg annenhver uke Monoterapi sammenlignet med placebo hos personer med moderat til alvorlig atopisk håndeksem som er kandidater for systemisk terapi

Hensikten med denne studien er å teste om behandling med tralokinumab er trygg og effektiv for å behandle moderat til alvorlig atopisk håndeksem. Dette vil bli vurdert ut fra en rekke vurderinger som vurderer alvorlighetsgraden og omfanget av atopisk håndeksem og dets symptomer, samt generell helsetilstand og livskvalitet.

Rettssaken vil vare i inntil 40 uker. Det vil være inntil 15 besøk, hvorav 3 vil foregå per telefon. Den første delen av forsøket kalles en screeningperiode og vil vare inntil 4 uker. I de første 16 ukene etter screening vil forsøksdeltakerne motta enten tralokinumab eller dummy-injeksjoner annenhver uke. Etter de første 16 ukene vil alle forsøksdeltakerne få tralokinumab-injeksjoner annenhver uke i 16 uker. Siste del av utprøvingen er en periode på 4 uker etter avsluttet behandlingsperiode, hvor forsøksdeltakerne er uten legemiddel for sikkerhetsoppfølging.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

235

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Belgia
      • Brussels, Belgia, 1200
        • LEO Pharma Investigational Site
      • Edegem, Belgia, 2650
        • LEO Pharma Investigational Site
      • Ghent, Belgia, 9000
        • LEO Pharma Investigational Site
  • Canada
      • Québec, Canada, G1W 4R4
        • LEO Pharma Investigational Site
      • Québec, Canada, G1V 4X7
        • LEO Pharma Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T3E 0B2
        • LEO Pharma Investigational Site
      • Edmonton, Alberta, Canada, T5J 3S9
        • LEO Pharma Investigational Site
      • Edmonton, Alberta, Canada, T6X 0N9
        • LEO Pharma Investigational Site
      • Red Deer, Alberta, Canada, T4P 1K4
        • LEO Pharma Investigational Site
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • LEO Pharma Investigational Site
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • LEO Pharma Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 3C3
        • LEO Pharma Investigational Site
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • LEO Pharma Investigational Site
      • Toronto, Ontario, Canada, M2N 3A6
        • LEO Pharma Investigational Site
      • Windsor, Ontario, Canada, N8T 1E6
        • LEO Pharma Investigational Site
    • Quebec
      • Saint-Jérôme, Quebec, Canada, J7Z 7E2
        • LEO Pharma Investigational Site
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35209
        • LEO Pharma Investigational Site
    • Arkansas
      • Fort Smith, Arkansas, Forente stater, 72916
        • LEO Pharma Investigational Site
    • California
      • Fountain Valley, California, Forente stater, 92708
        • LEO Pharma Investigational Site
      • Los Angeles, California, Forente stater, 90025
        • LEO Pharma Investigational Site
      • Sacramento, California, Forente stater, 95816
        • LEO Pharma Investigational Site
    • Connecticut
      • Farmington, Connecticut, Forente stater, 06032
        • LEO Pharma Investigational Site
    • Florida
      • Hialeah, Florida, Forente stater, 33012
        • LEO Pharma Investigational Site
    • Indiana
      • Plainfield, Indiana, Forente stater, 46168
        • LEO Pharma Investigational Site
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40217
        • LEO Pharma Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70115
        • LEO Pharma Investigational Site
    • Maine
      • Bangor, Maine, Forente stater, 04401
        • LEO Pharma Investigational Site
    • Michigan
      • Caledonia, Michigan, Forente stater, 49316
        • LEO Pharma Investigational Site
      • Detroit, Michigan, Forente stater, 48202
        • LEO Pharma Investigational Site
    • New Hampshire
      • Portsmouth, New Hampshire, Forente stater, 03801
        • LEO Pharma Investigational Site
    • New York
      • Cortland, New York, Forente stater, 13045
        • LEO Pharma Investigational Site
      • New York, New York, Forente stater, 10075
        • LEO Pharma Investigational Site
    • Oregon
      • Portland, Oregon, Forente stater, 97210
        • LEO Pharma Investigational Site
      • Portland, Oregon, Forente stater, 97201
        • LEO Pharma Investigational Site
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37211
        • LEO Pharma Investigational Site
    • Texas
      • Dallas, Texas, Forente stater, 75225
        • LEO Pharma Investigational Site
      • Frisco, Texas, Forente stater, 75034
        • LEO Pharma Investigational Site
      • San Antonio, Texas, Forente stater, 78213
        • LEO Pharma Investigational Site
      • Webster, Texas, Forente stater, 77598
        • LEO Pharma Investigational Site
  • Frankrike
      • Nantes, Frankrike, 44093
        • LEO Pharma Investigational Site
      • Pierre-Bénite, Frankrike, 69495
        • LEO Pharma Investigational Site
      • Rouen, Frankrike, 76031
        • LEO Pharma Investigational Site
  • Nederland
      • Amsterdam, Nederland, 1105 AZ
        • LEO Pharma Investigational Site
      • Groningen, Nederland, 9713 GZ
        • LEO Pharma Investigational Site
  • Polen
      • Gdansk, Polen, 80-462
        • LEO Pharma Investigational Site
      • Krakow, Polen, 30-033
        • LEO Pharma Investigational Site
      • Krakow, Polen, 31-011
        • LEO Pharma Investigational Site
  • Spania
      • Alicante, Spania, 03010
        • LEO Pharma Investigational Site
      • Barcelona, Spania, 08916
        • LEO Pharma Investigational Site
      • Granada, Spania, 18016
        • LEO Pharma Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spania, 08916
        • LEO Pharma Investigational Site
  • Storbritannia
      • London, Storbritannia, SE1 7EH
        • LEO Pharma Investigational Site
    • Greater Manchester
      • Salford, Greater Manchester, Storbritannia, M6 8HD
        • LEO Pharma Investigational Site
    • North Yorkshire
      • Middlesbrough, North Yorkshire, Storbritannia, TS4 3BW
        • LEO Pharma Investigational Site
  • Sør -Korea
      • Daegu, Sør -Korea, 41944
        • LEO Pharma Investigational Site
      • Seoul, Sør -Korea, 03080
        • LEO Pharma Investigational Site
      • Seoul, Sør -Korea, 04763
        • LEO Pharma Investigational Site
      • Seoul, Sør -Korea, 05030
        • LEO Pharma Investigational Site
      • Seoul, Sør -Korea, 05278
        • LEO Pharma Investigational Site
      • Seoul, Sør -Korea, 4564
        • LEO Pharma Investigational Site
    • Gangwon-do
      • Wŏnju, Gangwon-do, Sør -Korea, 26426
        • LEO Pharma Investigational Site
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, Sør -Korea, 15355
        • LEO Pharma Investigational Site
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, Sør -Korea, 05278
        • LEO Pharma Investigational Site
  • Tyskland
      • Bretzenheim, Tyskland, 55128
        • LEO Investigational Site
      • Frankfurt am Main, Tyskland, 60590
        • LEO Pharma Investigational Site
      • Haßfurt, Tyskland, 97437
        • LEO Pharma Investigational Site
      • Osnabrück, Tyskland, 49074
        • LEO Pharma Investigational Site
      • Tübingen, Tyskland, 72076
        • LEO Pharma Investigational Site
      • Wuppertal, Tyskland, 42283
        • LEO Pharma Investigational Site

Deltakelseskriterier

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

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Alder 18 år eller eldre ved screening
  • Diagnose av atopisk dermatitt (AD) i henhold til Hanifin og Rajka (1980) kriteriene for AD
  • Historie om AD i ≥1 år
  • Tilstedeværelse av atopisk håndeksem (AHE) som har vedvart i mer enn 3 måneder eller kommet tilbake to ganger eller mer i løpet av de siste 12 månedene, med unngåelse av kjente og relevante irritanter og allergener
  • AD involvering av minst ett kroppssted annet enn hender og håndledd ved screening
  • En etterforskers globale vurdering AHE-poengsum på 3 eller 4 (moderat til alvorlig) ved screening og baseline
  • En HESD-kløescore (ukentlig gjennomsnitt) på ≥4 ved baseline
  • Forsøkspersoner som har en dokumentert nyere historie (innen 12 måneder før screeningbesøket) med utilstrekkelig respons på behandling av AHE med aktuelle reseptbelagte medisiner eller for hvem lokalbehandling på annen måte er medisinsk utilrådelig (f.eks. på grunn av viktige bivirkninger eller sikkerhetsrisikoer)

Ekskluderingskriterier:

  • Forsøkspersoner må ikke delta i forsøket hvis de har andre aktive undertyper av håndeksem enn AHE som anses å være den dominerende årsaken til det aktuelle håndeksem, inkludert:

    • Aktiv irriterende kontakteksem
    • Aktiv allergisk kontakteksem
    • Aktiv proteinkontakteksem/kontakturticaria
    • Aktivt hyperkeratotisk håndeksem
    • Aktivt vesikulært håndeksem (pompholyx)
  • Aktive dermatologiske tilstander som kan forvirre diagnosen AD eller AHE, eller som vil forstyrre vurderingen av behandlingen
  • Bruk av solsenger eller fototerapi (f.eks. UVB, UVA1, PUVA), eller Grenz-strålebehandling på hender eller håndledd innen 28 dager før baseline eller bruk av blekebad på hender eller håndledd innen 7 dager før baseline
  • Behandling med systemiske immunsuppressive/immunmodulerende legemidler og/eller systemiske kortikosteroider innen 28 dager før baseline
  • Behandling med topikale kortikosteroider, topikale kalsineurinhemmere, topikale fosfodiesterase 4-hemmere eller topikale Janus-kinasehemmere innen 7 dager før baseline
  • Mottak av enhver markedsført biologisk terapi (dvs. immunglobulin, anti-immunoglobulin E) inkludert dupilumab eller biologiske undersøkelsesmidler 3 til 6 måneder før baseline

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Tralokinumab
Tralokinumab administreres i 32 uker (16 uker dobbeltblindet periode + 16 uker åpen periode)
Legemiddel: Tralokinumab
Etter en startdose på 600 mg under huden (s.c.) ved baseline, får forsøksdeltakerne en dose på 300 mg annenhver uke i 32 uker
Placebo komparator: Placebo + tralokinumab
Placebo administreres i 16 uker (dobbeltblindet periode) før overgang til en 16 ukers åpen periode hvor tralokinumab administreres
Legemiddel: Placebo
Etter en startdose under huden (s.c.) ved baseline, får forsøksdeltakerne en placebodose annenhver uke i 16 uker

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)
Tidsramme: At Week 16
IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At Week 16

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Having a ≥2-point Reduction in IGA-AHE Score
Tidsramme: From baseline to Week 16
IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
From baseline to Week 16
Percentage of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75)
Tidsramme: From baseline (Day 1) to Week 16
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.
From baseline (Day 1) to Week 16
Percentage of Participants Having a Decrease in HECSI of at Least 50% (HECSI-50)
Tidsramme: From baseline to Week 16
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-50 is defined as at least 50% improvement in HECSI score from baseline.
From baseline to Week 16
Percentage of Participants Having a Decrease in HECSI of at Least 90% (HECSI-90)
Tidsramme: From baseline to Week 16
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.
From baseline to Week 16
Percentage Change in HECSI Score
Tidsramme: From baseline to Week 16
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity.
From baseline to Week 16
Percentage of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points
Tidsramme: From baseline to Week 16
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
From baseline to Week 16
Percentage Change in HESD Itch Score (Weekly Average)
Tidsramme: From baseline to Week 16
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
From baseline to Week 16
Percentage of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points
Tidsramme: From baseline to Week 16
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
From baseline to Week 16
Percentage Change in HESD Pain Score (Weekly Average)
Tidsramme: From baseline to Week 16
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
From baseline to Week 16
Percentage Change in HEIS Score
Tidsramme: From baseline to Week 16
HEIS: The Hand Eczema Impact Scale (HEIS) includes 9 items addressing the participant's perception of the impact of hand eczema on their daily activities: embarrassment, frustration, sleep, work, and physical functioning over the past 7 days. Each item is scored on a 5-point scale (0='not at all', 1='a little', 2='moderately', 3='a lot', 4='extremely'). The HEIS score is the average of the 9 items.
From baseline to Week 16
Percentage Change in DLQI Score
Tidsramme: From baseline to Week 16
The Dermatology Life Quality Index (DLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.
From baseline to Week 16
Change in WPAI+CIQ:AHE Domain Scores
Tidsramme: From baseline to Week 16
The impact of AHE on the subject's ability to work/school and perform regular activities was assessed by Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire in atopic hand eczema (WPAI+CIQ:AHE), which is an instrument to measure impairments in both paid work and unpaid work/school attendance. Only domain scores where an estimand analysis was possible are presented. Scores are on a scale from 0 to 100 and reflect the percentage impairment due to AHE during the past 7 days, with higher numbers indicating greater impairment and less productivity/school attendance.
From baseline to Week 16
Number of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)
Tidsramme: At Week 32
The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At Week 32
Number of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75)
Tidsramme: From baseline to Week 32
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score ranges from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.
From baseline to Week 32
Number of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points
Tidsramme: From baseline to Week 32
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
From baseline to Week 32
Number of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points
Tidsramme: From baseline to Week 32
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
From baseline to Week 32
Percentage Change in HEIS Score
Tidsramme: From baseline to Week 32
HEIS: The Hand Eczema Impact Scale (HEIS) includes 9 items addressing the participant's perception of the impact of hand eczema on their daily activities: embarrassment, frustration, sleep, work, and physical functioning over the past 7 days. Each item is scored on a 5-point scale (0='not at all', 1='a little', 2='moderately', 3='a lot', 4='extremely'). The HEIS score is the average of the 9 items.
From baseline to Week 32
Percentage Change in DLQI Score
Tidsramme: From baseline to Week 32
The Dermatology Life Quality Index (DLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.
From baseline to Week 32
Change in WPAI+CIQ:AHE Domain Scores
Tidsramme: From baseline to Week 32
The impact of AHE on the subject's ability to work/school and perform regular activities was assessed by Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire in atopic hand eczema (WPAI+CIQ:AHE), which is an instrument to measure impairments in both paid work and unpaid work/school attendance. Only domain scores where an estimand analysis was possible are presented. Scores are on a scale from 0 to 100 and reflect the percentage impairment due to AHE during the past 7 days, with higher numbers indicating greater impairment and less productivity/school attendance.
From baseline to Week 32
Number of Treatment-emergent Adverse Events
Tidsramme: From baseline to Week 16
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
From baseline to Week 16
Number of Treatment-emergent Adverse Events During the Open-label Treatment Period
Tidsramme: Week 16 to Week 32
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
Week 16 to Week 32

Samarbeidspartnere og etterforskere

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

Sponsor

LEO Pharma

Etterforskere

  • Studieleder: Medical Expert, LEO Pharma

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)

28. august 2023

Primær fullføring (Faktiske)

5. mai 2025

Studiet fullført (Faktiske)

22. september 2025

Datoer for studieregistrering

Først innsendt

13. juli 2023

Først innsendt som oppfylte QC-kriteriene

13. juli 2023

Først lagt ut (Faktiske)

24. juli 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LP0162-2328
  • U1111-1285-7014 (Annen identifikator: World Health Organization (WHO))
  • 2022-502653-34-00 (Ctis: European Medicines Agency (EMA))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Avidentifisert IPD kan gjøres tilgjengelig for forskere i et lukket miljø for en bestemt tidsperiode

Tilgangskriterier for IPD-deling

Datadeling er underlagt godkjent vitenskapelig forsvarlig forskningsforslag og signert datadelingsavtale.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

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