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Langtidsundersøgelse (AtDvance) for at evaluere GSK1070806 i atopisk dermatitis. (AtDvance)

20. maj 2026 opdateret af: GlaxoSmithKline

Langsigtet forlængelsesundersøgelse (AtDvance) for at evaluere sikkerheden og effektiviteten af ​​GSK1070806 hos deltagere med moderat til svær atopisk dermatitis.

Undersøgelsen er designet til at evaluere den langsigtede sikkerhed og effektivitet af GSK1070806 hos deltagere med moderat til svær atopisk dermatitis, som har gennemført fase 2b moder GSK atopisk dermatitis (ATD) undersøgelse (NCT05999799).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

79

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • GSK Investigational Site
      • Buenos Aires, Argentina, C1055AAO
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno, Argentina, C1056ABI
        • GSK Investigational Site
      • Córdoba, Argentina, X5000AAW
        • GSK Investigational Site
      • Rosario, Argentina, S2002
        • GSK Investigational Site
  • Bulgarien
      • Pleven, Bulgarien, 5800
        • GSK Investigational Site
      • Sofia, Bulgarien, 1510
        • GSK Investigational Site
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • GSK Investigational Site
      • London, Ontario, Canada, N6H 5L5
        • GSK Investigational Site
      • Markham, Ontario, Canada, L3P1X2
        • GSK Investigational Site
  • Forenede Stater
    • California
      • Fountain Valley, California, Forenede Stater, 92708
        • GSK Investigational Site
    • Florida
      • Pompano Beach, Florida, Forenede Stater, 33334
        • GSK Investigational Site
    • Georgia
      • Fayetteville, Georgia, Forenede Stater, 30214
        • GSK Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10075
        • GSK Investigational Site
    • Ohio
      • Dublin, Ohio, Forenede Stater, 43016
        • GSK Investigational Site
    • Texas
      • Santa Monica, Texas, Forenede Stater, 90404
        • GSK Investigational Site
  • Frankrig
      • La Rochelle, Frankrig, 17019
        • GSK Investigational Site
  • Grækenland
      • Athens, Grækenland
        • GSK Investigational Site
  • Japan
      • Chiba, Japan, 272-0033
        • GSK Investigational Site
      • Fukuoka, Japan, 812-8582
        • GSK Investigational Site
      • Fukuoka, Japan, 807-8556
        • GSK Investigational Site
      • Gunma, Japan, 370-0829
        • GSK Investigational Site
      • Hokkaido, Japan, 060-0033
        • GSK Investigational Site
      • Hokkaido, Japan, 080-0013
        • GSK Investigational Site
      • Kanagawa, Japan, 211-0063
        • GSK Investigational Site
      • Osaka, Japan, 583-8588
        • GSK Investigational Site
      • Osaka, Japan, 593-8324
        • GSK Investigational Site
      • Saitama, Japan, 343-8555
        • GSK Investigational Site
  • Kina
      • Chongqing, Kina, 400016
        • GSK Investigational Site
      • Hangzhou, Kina, 310000
        • GSK Investigational Site
      • Shanghai, Kina, 200025
        • GSK Investigational Site
      • Shanghai, Kina
        • GSK Investigational Site
  • Mexico
      • Chihuahua City, Mexico, 31000
        • GSK Investigational Site
      • Durango, Mexico, 34000
        • GSK Investigational Site
      • Guadalajara, Mexico, 44628
        • GSK Investigational Site
  • Panama
      • Panama City, Panama, 7099
        • GSK Investigational Site
  • Polen
      • Elblag, Polen, 82-300
        • GSK Investigational Site
      • Katowice, Polen, 40-600
        • GSK Investigational Site
      • Szczecin, Polen, 70-332
        • GSK Investigational Site
  • Spanien
      • Córdoba, Spanien, 14004
        • GSK Investigational Site
      • Granada, Spanien, 18016
        • GSK Investigational Site
      • Vigo, Spanien, 36206
        • GSK Investigational Site
  • Sydkorea
      • Ansan, Sydkorea, 15355
        • GSK Investigational Site
      • Seoul, Sydkorea, 04763
        • GSK Investigational Site
      • Seoul, Sydkorea, 03722
        • GSK Investigational Site
      • Seoul, Sydkorea, 100 799
        • GSK Investigational Site
      • Seoul, Sydkorea, 150-950
        • GSK Investigational Site
  • Tjekkiet
      • Prague, Tjekkiet, 10034
        • GSK Investigational Site
      • Prague, Tjekkiet
        • GSK Investigational Site
  • Tyskland
      • Berlin, Tyskland, 10789
        • GSK Investigational Site
      • Münster, Tyskland, 48149
        • GSK Investigational Site

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Deltagerne skal underskrive og datere samtykkedokumentet.
  • Deltagere diagnosticeret med moderat til svær atopisk dermatitis (AtD), som har gennemført det kvalificerende fase 2 forældrestudie (NCT05999799) af GlaxoSmithKline (GSK's) AtD og, efter deres mening, kan drage fordel af GSK1070806.
  • Vær forsætlig og i stand til at besøge lægen på klinikken efter aftale og følg alle procedurer relateret til forskningsundersøgelser og spørgeskemaer (i stand til at læse og forstå Patient-rapporterede udfald (PRO) spørgeskemaer og være i stand til at bruge elektroniske enheder).
  • Brugen af ​​svangerskabsforebyggende metoder til kvinder bør være i overensstemmelse med lokale regler for svangerskabsforebyggende metoder for deltagere, der deltager i kliniske forskningsprogrammer.
  • Kvindelige deltagere er berettiget til at deltage i forskningsprogrammet, hvis de ikke er gravide eller ammer og opfylder en af ​​følgende betingelser:
  • Det er Woman of non-conventional potential (WONCBP).
  • Det er kvinde i den fødedygtige alder (WOCBP) og bruger en yderst effektiv præventionsmetode, der har en fejlrate på mindre end (<) 1 procent (%) i løbet af forsøgsdosisperioden og i mindst 16 uger efter den sidste dosis af forskningslægemidlet . Vi bør vurdere sandsynligheden for svigt af prævention (f.eks. manglende samarbejde, tidlig prævention) forbundet med den første dosis af lægemidlet.
  • WOCBP skal opnå et negativt resultat i en meget følsom graviditetstest (ved urin- eller serumtest, som foreskrevet af lokale regler) før den første dosis af forskningslægemidlet.
  • Hvis urintesten er positiv, eller det negative resultat ikke kan bekræftes (dvs. resultatet er uklart), er en graviditetstest ved serumtest påkrævet. I sådanne tilfælde, hvis serumet er testet, er testresultatet positivt. Deltagere skal udelukkes fra forskningsprojektet.
  • Yderligere krav til testning af graviditet under og efter eksponering for lægemidlet.
  • Forskeren er ansvarlig for at undersøge sygehistorie, menstruationscyklushistorie og seksuel aktivitet på kort sigt. For at reducere risikoen for screening af gravide kvinder, som måske ikke opdages i begyndelsen af ​​graviditeten.

Ekskluderingskriterier:

  • Permanent seponering af studielægemidlet til enhver tid under GSK's kvalificerende fase 2 AtD (NCT05999799) eller en medicinsk tilstand, der ville hindre GSK's deltagelse i fase 2 219538 (NCT05999799) AtD-forskningsprojektet.
  • Deltagere, der under GSKs kvalificerende fase 2 (NCT05999799) AtD-forskningsprojekt udviklede adverse event (AE) eller Serious adverse event (SAE) baseret på laboratorieparametre, fysisk undersøgelse, vitale tegn, Elektrokardiogram (EKG), sygehistorie osv. Medicinsk Historien tyder efter forskernes mening på, at hvis Investigational Medicinal Product (IMP) fortsættes, kan det medføre unødvendig risiko for deltagerne.
  • Aktuel medicin til AtD inden for 1 uge før din aftale på dag 1, såsom: Topiske calcineurinhæmmere (TCI)/ Topikale kortikosteroider (TCS), Phosphodiesterase-4 (PDE-4) og Janus aktiveringskinasehæmmere (JAKi) til ekstern brug .
  • Topikale kortikosteroider (TCS) (såsom hydrocortison, betamethason)
  • Topiske calcineurinhæmmere (TCI) (såsom tacrolimus, pimecrolimus)
  • Phosphodiesterase-4 (PDE4) hæmmer til ekstern brug (f.eks. crisaborol)
  • JAKi til ekstern brug (f.eks. ruxolitinib)
  • Medicin til lokalt brug, eller andre naturlægemidler/traditionelle lægemidler, der kan påvirke den AtD, som deltagerne er i.
  • Deltager, som modtog systemisk terapi, som anses for kontraindiceret, herunder systemisk terapi anvendt som redningsmedicin mod AtD, fra screeningen for GSKs fase 2 AtD 219538 forskningsprojekt, indtil LTE-protokollen startede, var ude af stand til at deltage i forskningsprojektet.
  • Kroniske ukontrollerede sygdomme, der kan kræve øjeblikkelige orale kortikosteroider, såsom svær ukontrolleret astma (defineret som at have en astmakontrolspørgeskema (ACQ)-5-score større end eller lig med (>=) på 1,5 eller en historie med astma-eksacerbationer. >= 2 gange inden for de sidste 12 måneder, kræver systemisk kortikosteroid [oral og/eller intravenøs medicin] eller kræver et >-24-timers hospitalsophold)
  • Erfaring med deltagelse i tidligere/igangværende kliniske forskningsprojekter.
  • Deltagerne har deltaget i andre kliniske forskningsstudier. Dette er et supplement til GSK's Phase 2 219538 (NCT05999799) forskningsprojekt.

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
Placebo komparator: Placebo/Placebo
Participants were previously treated with placebo in parent Study 219538 (NCT05999799) and continued on placebo subcutaneous (SC) injection in this long-term extension (LTE) study.
Medicin: Placebo
Deltagerne vil modtage Placebo
Eksperimentel: Placebo/GSK1070806 Dose Level 4
Participants were previously treated with placebo in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.
Medicin: GSK1070806
Deltagerne modtager GSK1070806
Medicin: Placebo
Deltagerne vil modtage Placebo
Eksperimentel: GSK1070806 Dose Level 1/GSK1070806 Dose Level 1
Participants were previously treated with GSK1070806 dose level 1 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 1 SC injection in this LTE study. Dose level 1 is the lowest dose level.
Medicin: GSK1070806
Deltagerne modtager GSK1070806
Eksperimentel: GSK1070806 Dose Level 1/GSK1070806 Dose Level 4
Participants were previously treated with GSK1070806 dose level 1 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.
Medicin: GSK1070806
Deltagerne modtager GSK1070806
Eksperimentel: GSK1070806 Dose Level 2/GSK1070806 Dose Level 2
Participants were previously treated with GSK1070806 dose level 2 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 2 SC injection in this LTE study. Dose level 2 is greater than dose level 1.
Medicin: GSK1070806
Deltagerne modtager GSK1070806
Eksperimentel: GSK1070806 Dose Level 2/GSK1070806 Dose Level 4
Participants were previously treated with GSK1070806 dose level 2 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.
Medicin: GSK1070806
Deltagerne modtager GSK1070806
Eksperimentel: GSK1070806 Dose Level 3/GSK1070806 Dose Level 3
Participants were previously treated with GSK1070806 dose level 3 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 3 SC injection in this LTE study. Dose level 3 is greater than dose level 2.
Medicin: GSK1070806
Deltagerne modtager GSK1070806
Eksperimentel: GSK1070806 Dose Level 3/GSK1070806 Dose Level 4
Participants were previously treated with GSK1070806 dose level 3 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.
Medicin: GSK1070806
Deltagerne modtager GSK1070806
Eksperimentel: GSK1070806 Dose Level 4/GSK1070806 Dose Level 4
Participants were previously treated with GSK1070806 dose level 4 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.
Medicin: GSK1070806
Deltagerne modtager GSK1070806

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to Week 59
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state. Safety Analysis Set included all assigned participants who received at least 1 dose of study intervention in this LTE study. Participants were analyzed according to the intervention they actually received.
Up to Week 59
Number of Participants With TEAEs Leading to Permanent Discontinuation
Tidsramme: Up to Week 59
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state. Number of participants with TEAE leading to permanent discontinuation of GSK1070806 were reported.
Up to Week 59
Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: Up to Week 59
An SAE is defined as any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), is a suspected transmission of any infectious agent via an authorized medicinal product, and medically important were categorized as SAE.
Up to Week 59
Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESI)
Tidsramme: Up to Week 59
AESI for GSK1070806 include serious infections, opportunistic infections, serious hypersensitivity reactions, and injection site reactions (ISRs). A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state.
Up to Week 59

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Achieved Investigators Global Assessment (IGA) Response (IGA Score of 0 or 1 and a Reduction of Greater Than or Equal to [>=]2 Points From Baseline) at Weeks 16, 32, and 48
Tidsramme: Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
IGA is a clinical tool to assess current state/severity of participant's atopic dermatitis (AtD). It is static 5-point morphological assessment of overall disease severity at time of assessment (TOA) determined by investigator, sub-investigator, or trained healthcare professional with required qualifications on scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, & 4=severe). Higher score=high severity of disease. Data for IGA 0 or 1 responders is presented in this outcome measure. IGA 0 or 1 responders: participants whose IGA score was 'Clear' (0) or 'Almost Clear' (1) & had reduction of >=2 points from Baseline at each visit. 2 participants had their assigned Dose Level (DL) modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4.
Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
Number of Participants Who Achieved Reduction of Greater Than or Equal to (>=) 75 Percent (%) in Eczema Area and Severity Index (EASI) Score From Baseline at Weeks 16, 32 and 48
Tidsramme: Baseline (Day 1 from the parent study), Weeks 16, 32 and 48
EASI scoring system is standardized clinical tool for assessment of extent(area) & severity of AtD.Severity of clinical signs of AtD(erythema, induration/papulation,excoriation & lichenification) scored separately for each of 4 body regions(head & neck, upper limbs, trunk & lower limbs) on 4-point scale: 0=absent;1=mild;2=moderate;3=severe. EASI area score was based upon % body surface area with AtD in body region:0=0%,1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score was obtained by multiplying EASI area scores (0-6) with severity scores (0-3) of all 4 body regions; it ranges from 0 to 72, with higher scores= more severe or extensive condition. 2 participants had their assigned DL modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4.
Baseline (Day 1 from the parent study), Weeks 16, 32 and 48
Number of Participants Who Achieved Reduction of >=4 Points in Peak Pruritus Numerical Rating Scale (PP-NRS) Score From Baseline at Weeks 16, 32, and 48
Tidsramme: Baseline (Day -7 to Day -1 from the parent study), Weeks 16, 32, and 48
PP-NRS is a patient reported measure of pruritus (itch) intensity assessing worst itch (in the past 24 hours). The values were evaluated using an 11-point scale (from 0 to 10), with 0 being no itch and 10 being the worst imaginable itch. Higher scores indicated worst itch. 2 participants had their assigned dose level (DL) modified during the study, hence were included in treatment arm of the highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4. Baseline was averaged from daily values from Day -7 to Day -1 of the parent study 219538 (NCT05999799).
Baseline (Day -7 to Day -1 from the parent study), Weeks 16, 32, and 48
Number of Participants Who Maintained IGA Response (IGA Score of 0 or 1 and a Reduction of >=2 Points From Baseline) at Weeks 16, 32, and 48
Tidsramme: Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
IGA is clinical tool to assess current state/severity of a participant's AtD. It measures overall disease severity at TOA(determined by investigator) using static 5-point scale(0-4): 0=clear,1=almost clear,2=mild,3=moderate,4-=severe. Higher scores indicate greater severity. IGA 0/1 responders are participants whose IGA score was 'Clear'(0) or 'Almost Clear'(1) & had reduction of >=2 points from Baseline at each visit. 2 participants had their assigned DL modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4. Response is considered maintained if achieved at Week 16 and sustained at later LTE timepoints; earliest maintenance timepoint was Week 32.
Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
Number of Participants Who Maintained Response of Reduction of >= 75% in EASI Score From Baseline at Weeks 16, 32, and 48
Tidsramme: Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
EASI: standardized clinical tool to assess extent(area) & severity of AtD.Severity of signs (erythema,induration/papulation,excoriation & lichenification) scored on 0-3 scale (0=absent;1=mild;2=moderate;3=severe) across 4 regions: head&neck, upper limbs, trunk, & lower limbs. Area score reflects % body surface area with AtD per region:0=0%,1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score=area scores(0-6) multiplied by severity scores(0-3) across regions; range: 0-72, higher scores=more severe/extensive disease. 2 participants had their assigned DL modified during study, hence included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', & 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4. Response is considered maintained if achieved at Week 16 and sustained at later LTE timepoints; earliest maintenance timepoint was Week 32.
Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
Percent Change From Baseline (CFB) in EASI Score at Weeks 16, 32, and 48
Tidsramme: Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
EASI: standardized clinical tool to assess extent(area) & severity of AtD.Severity of signs (erythema,induration/papulation,excoriation & lichenification) scored on 0-3 scale (0=absent;1=mild;2=moderate;3=severe) across 4 regions: head&neck, upper limbs, trunk, & lower limbs. Area score reflects % body surface area with AtD per region:0=0%,1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score=area scores(0-6) multiplied by severity scores(0-3) across regions; range: 0-72, higher scores=more severe/extensive disease. CFB=post-dose visit value minus Baseline value (BV). Percent CFB=CFB value divided by BV & multiplied by 100. Two participants had their assigned DL modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', & 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4.
Baseline (Day 1 from the parent study), Weeks 16, 32, and 48

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

Efterforskere

  • Studieleder: GSK Clinical Trials, GlaxoSmithKline

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)

5. juni 2024

Primær færdiggørelse (Faktiske)

29. juli 2025

Studieafslutning (Faktiske)

29. juli 2025

Datoer for studieregistrering

Først indsendt

3. juni 2024

Først indsendt, der opfyldte QC-kriterier

3. juni 2024

Først opslået (Faktiske)

7. juni 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 220723
  • 2023-508474-29-00 (Registry Identifier: CTIS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til anonymiserede data på individuelt patientniveau (IPD) og relaterede undersøgelsesdokumenter fra de kvalificerede undersøgelser via datadelingsportalen. Detaljer om GSK's datadelingskriterier kan findes på: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD-delingstidsramme

Anonymiseret IPD vil blive gjort tilgængelig inden for 6 måneder efter offentliggørelsen af ​​primære, sekundære nøgle- og sikkerhedsresultater for undersøgelser af produkter med godkendte indikationer eller afsluttede aktiv(er) på tværs af alle indikationer.

IPD-delingsadgangskriterier

Anonymiseret IPD deles med forskere, hvis forslag er godkendt af et uafhængigt reviewpanel og efter en datadelingsaftale er på plads. Adgangen gives i en indledende periode på 12 måneder, men en forlængelse kan gives, når det er berettiget, i op til 6 måneder.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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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