Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

En fase 2-dosisvarierende undersøgelse af LY4100511 (terning 853) hos voksne deltagere med moderat til svær plakpsoriasis

24. juli 2026 opdateret af: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

En fase 2, multicenter, randomiseret, dobbeltblind, placebokontrolleret, parallelgruppe, dosisvarierende undersøgelse af LY4100511 (DC-853) til behandling af voksne deltagere med moderat til svær plakpsoriasis

Hovedformålet med denne undersøgelse er at vurdere sikkerheden og effektiviteten af ​​LY4100511 hos voksne deltagere med moderat til svær plaque psoriasis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

222

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1W 4V5
        • Interior Dermatology Centre - Probity - PPDS
      • Nanaimo, British Columbia, Canada, V9T1W1
        • Skin Care West
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Simcoderm Medical & Surgical Dermatology Centre
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dermatrials Research Inc.
      • London, Ontario, Canada, N6H 5L5
        • DermEffects - Probity - PPDS
      • London, Ontario, Canada, N6A 5R9
        • Lovegrove Dermatology - Probity - PPDS
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc.
      • Mississauga, Ontario, Canada, L4Y 4C5
        • DermEdge Research
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35244
        • Cahaba Dermatology Skin Health Center
    • Arkansas
      • Bryant, Arkansas, Forenede Stater, 72022
        • Dermatology Trial Associates
    • California
      • Beverly Hills, California, Forenede Stater, 90212
        • Zenith Research, Inc.
      • Fountain Valley, California, Forenede Stater, 92708
        • First OC Dermatology Research Inc
      • Fremont, California, Forenede Stater, 94538-1614
        • Center for Dermatology Clinical Research
      • Los Angeles, California, Forenede Stater, 90045
        • Dermatology Research Associates
      • Santa Monica, California, Forenede Stater, 90404
        • Clinical Science Institute
    • Florida
      • Coral Gables, Florida, Forenede Stater, 33134
        • Driven Research
      • Hialeah, Florida, Forenede Stater, 33012
        • Direct Helpers Research Center
      • Ocala, Florida, Forenede Stater, 34470
        • Renstar Medical Research
      • St. Petersburg, Florida, Forenede Stater, 33713-8012
        • GCP Global Clinical Professionals, LLC
      • Tampa, Florida, Forenede Stater, 33613
        • ForCare Clinical Research
    • Illinois
      • Skokie, Illinois, Forenede Stater, 60077-1049
        • Endeavor Clinical Trials Center - Dermatology - Skokie
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20850
        • Lawrence J Green, M.D, LLC
    • Texas
      • Webster, Texas, Forenede Stater, 77598
        • Center for Clinical Studies, LTD.LLP
  • Japan
      • Tokyo, Japan
        • Igarashi Dermatological Clinic
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 450-0003
        • Nagoya City University Hospital
    • Hakkaido
      • Sapporo, Hakkaido, Japan, 060-0063
        • Medical Corporation Kojinkai Sapporo Skin Clinic
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-0063
        • Katahira Dermatology Urology Clinic
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 861-4101
        • Ohyama Dermatology Clinic
    • Osaka
      • Sakai-shi, Osaka, Japan, 593-8324
        • Kume Clinic
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tachikawa, Tokyo, Japan, 190-0023
        • Tachikawa Dermatology Clinic
    • Toyama
      • Takaoka, Toyama, Japan, 933-0871
        • Shirasaki dermatology clinic
  • Polen
      • Katowice, Polen, 40-611
        • Centrum Medyczne Angelius Provita
      • Warsaw, Polen, 02-665
        • Centrum Medyczne Reuma Park NZOZ
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polen, 50-566
        • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
      • Wroclaw, Lower Silesian Voivodeship, Polen, 50-381
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 00-710
        • Clinical Best Solutions
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Polen, 35-055
        • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polen, 80-382
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdynia, Pomeranian Voivodeship, Polen, 81-537
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
    • Silesian Voivodeship
      • Częstochowa, Silesian Voivodeship, Polen, 42-202
        • Synexus Polska Sp. z o.o. Oddzial w Czestochowie
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Polen, 70-332
        • Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polen, 90-436
        • Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
  • Tjekkiet
      • Pardubice, Tjekkiet, 530 02
        • Pratia Pardubice a.s. - PRATIA - PPDS
      • Prague, Tjekkiet, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Tjekkiet, 13000
        • Pratia Prague s.r.o. - PRATIA - PPDS
      • Prague, Tjekkiet, 160 00
        • Kozni ambulance Fialova, s.r.o. - CRC - PPDS
    • Praha 10
      • Prague, Praha 10, Tjekkiet, 10100
        • CLINTRIAL s.r.o.
  • Tyskland
      • Dresden, Tyskland, 1307
        • Universitätsklinikum Carl Gustav Carus an der TU
      • Hamburg, Tyskland, 22391
        • MensingDerma Research GmbH
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Tyskland, 72076
        • Universitatsklinikum Tubingen
    • Bavaria
      • Augsburg, Bavaria, Tyskland, 86150
        • Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
    • Hesse
      • Frankfurt am Main, Hesse, Tyskland, 60590
        • Universitätsklinikum Frankfurt
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Tyskland, 48149
        • Universitätsklinikum Münster
  • Ungarn
      • Gyöngyös, Ungarn, 3200
        • Gyongyosi Bugat Pal Korhaz
      • Veszprém, Ungarn, 8200
        • MedMare Bt
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Ungarn, 4032
        • Debreceni Egyetem Klinikai Kozpont
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Ungarn, 5000
        • Allergo-Derm Bakos Kft

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:

  • Klinisk diagnose af plaque psoriasis i 6 måneder før baseline dag 1 randomisering
  • Skal have et kropsmasseindeks (BMI) på 18 til 40 kilogram/kvadratmeter (kg/m2) (inklusive).
  • Skal være villig til at afbryde topiske og/eller systemiske behandlinger for psoriasis før den første dosis af undersøgelsesintervention.
  • Skal acceptere at undgå langvarig udsættelse for solen og at afstå fra brugen af ​​solariekabiner, sollamper og andre kilder til ultraviolet lys under undersøgelsen

Ekskluderingskriterier:

  • Har haft en klinisk signifikant opblussen af ​​psoriasis i løbet af de 12 uger før baseline, som vurderet af investigator.
  • Har en historie med erytrodermisk psoriasis, generaliseret eller lokaliseret pustuløs psoriasis, overvejende guttat psoriasis eller medicin-induceret eller medicin-forværret psoriasis.
  • Har nogen kendt eller mistænkt diagnose af inflammatoriske tilstande udover psoriasis og psoriasisgigt, herunder men ikke begrænset til leddegigt, sarkoidose, IBD (Crohns sygdom eller colitis ulcerosa) eller systemisk lupus erythematosus.
  • Har en diagnose af psoriasisgigt, der kræver eller er i øjeblikket i behandling med systemisk immunsuppressiv medicinsk behandling (herunder kortikosteroider, immunsuppressiva og biologiske midler).
  • Har en aktuel eller nylig akut, aktiv infektion. Deltageren må ikke have symptomer eller tegn på bekræftet eller mistænkt infektion og skal have gennemført enhver passende anti-infektionsbehandling i mindst 30 dage før screening og op til randomisering/baseline.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: LY4100511 200 mg BID
Participants received LY4100511 200 milligrams (mg) administered orally twice daily (BID) for 12 weeks.
Medicin: LY4100511
Indgives oralt
Eksperimentel: LY4100511 400 mg BID
Participants received LY4100511 400 mg administered orally BID for 12 weeks.
Medicin: LY4100511
Indgives oralt
Eksperimentel: LY4100511 800 mg QD
Participants received LY4100511 800 mg administered orally once daily (QD) for 12 weeks, with matching placebo administered in the evening.
Medicin: LY4100511
Indgives oralt
Placebo komparator: Placebo BID
Participants received placebo administered orally BID for 12 weeks.
Medicin: Placebo
Indgives oralt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 Versus Placebo)
Tidsramme: Week 12
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 200mg vs 400mg vs 800mg)
Tidsramme: Week 12
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving an sPGA Score of 0 (Clear) or 1 (Almost Clear) With ≥2 Grade Improvement From Baseline at Week 12
Tidsramme: Week 12

Percentage of participants achieving a static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with ≥2-grade improvement from baseline at Week 12. The investigator assessed psoriasis severity on a 5-point scale from 0 (clear) to 4 (severe):

  • 0 = Clear: No signs of psoriasis; post-inflammatory hyperpigmentation may occur
  • 1 = Almost clear: Normal to pink lesions; no thickening; no or minimal focal scaling
  • 2 = Mild: Pink to light red color; slight thickening; mainly fine scaling
  • 3 = Moderate: Dull bright red erythema; moderate thickening; moderate scaling
  • 4 = Severe: Bright to deep red; severe thickening with hard edges; coarse scaling covering most or all lesions
Week 12
Percentage of Participants Achieving ≥50% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-50) at Week 12
Tidsramme: Week 12
Percentage of participants achieving ≥50% reduction from baseline in PASI-50 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
Tidsramme: Week 12
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving ≥90% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-90) at Week 12
Tidsramme: Week 12
Percentage of participants achieving ≥90% reduction from baseline in PASI-90 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving ≥100% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-100) at Week 12
Tidsramme: Week 12
Percentage of participants achieving ≥100% reduction from baseline in PASI-100 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Change From Baseline in PASI Score at Week 12
Tidsramme: Baseline, Week 12

Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects.

The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Baseline, Week 12
Percent Change From Baseline in PASI Score at Week 12
Tidsramme: Baseline, Week 12

Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects.

The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Baseline, Week 12
Change From Baseline in the Percentage of Body Surface Area (BSA) Affected at Week 12
Tidsramme: Baseline, Week 12

Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value.

BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.
Baseline, Week 12
Percent Change From Baseline in the Percentage of BSA Affected at Week 12
Tidsramme: Baseline, Week 12

Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value.

BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.
Baseline, Week 12
Pharmacokinetics (PK): Steady State Maximum Concentration of LY4100511 (Cmax,ss)
Tidsramme: Day 1: Predose, 0.5, 1 hours postdose; Day 15: Predose, 0.5, 1, 4 hours postdose; Day 57: Predose, 0.5, 1, 4 hours postdose
Steady State Maximum Concentration of LY4100511 (Cmax,ss) is reported.
Day 1: Predose, 0.5, 1 hours postdose; Day 15: Predose, 0.5, 1, 4 hours postdose; Day 57: Predose, 0.5, 1, 4 hours postdose
Pharmacokinetics (PK): Steady State Trough Concentration (Ctrough,ss) of LY4100511
Tidsramme: Predose at Day 8, 15, 29, 57 and 85
Ctrough,ss of LY4100511
Predose at Day 8, 15, 29, 57 and 85
Number of Participants With TEAEs and SAEs Observed During the Study of LY4100511
Tidsramme: Baseline up to Week 12

The number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) observed during the study of LY4100511.

A TEAE is defined as an AE that occurs during or after the first study drug administration and up to and including the follow-up visit.

A serious adverse event (SAE) is any untoward medical occurrence at any dose that:

  • Results in death
  • Is life-threatening (risk of death at the time of the event)
  • Requires inpatient hospitalization or prolongation of existing hospitalization (excluding elective admission for a stable pre-existing condition)
  • Results in persistent disability/incapacity
  • Is a congenital anomaly/birth defect
  • Other medically important event that may jeopardize the participant or require intervention to prevent the above outcomes
Baseline up to Week 12

Samarbejdspartnere og efterforskere

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

Sponsor

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Efterforskere

  • Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

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)

25. oktober 2024

Primær færdiggørelse (Faktiske)

24. juli 2025

Studieafslutning (Faktiske)

4. september 2025

Datoer for studieregistrering

Først indsendt

16. september 2024

Først indsendt, der opfyldte QC-kriterier

16. september 2024

Først opslået (Faktiske)

19. september 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18845
  • J5C-MC-FOAB (Anden identifikator: DCE853201)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserede individuelle data på patientniveau vil blive leveret i et sikkert adgangsmiljø efter godkendelse af et forskningsforslag og en underskrevet datadelingsaftale.

IPD-delingstidsramme

Data er tilgængelige 6 måneder efter den primære offentliggørelse og godkendelse af den undersøgte indikation i USA og Den Europæiske Union (EU), alt efter hvad der er senere. Data vil være tilgængelige på ubestemt tid for anmodning.

IPD-delingsadgangskriterier

forskningsforslag skal godkendes af et uafhængigt bedømmelsespanel, og forskere skal underskrive en datadelingsaftale.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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 .

Abonner