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Uno studio di fase 2 di dosaggio di LY4100511 (Dice 853) in partecipanti adulti con psoriasi a placche da moderata a grave

24 luglio 2026 aggiornato da: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Uno studio di fase 2, multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, con dosaggio variabile di LY4100511 (DC-853) per il trattamento di partecipanti adulti con psoriasi a placche da moderata a grave

Lo scopo principale di questo studio è valutare la sicurezza e l'efficacia di LY4100511 nei partecipanti adulti con psoriasi a placche da moderata a grave.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

222

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Criteri di inclusione:

  • Diagnosi clinica di psoriasi a placche per 6 mesi prima della randomizzazione al basale del giorno 1
  • Deve avere un indice di massa corporea (BMI) compreso tra 18 e 40 chilogrammi/metro quadrato (kg/m2) (incluso).
  • Deve essere disposto a interrompere le terapie topiche e/o sistemiche per la psoriasi prima della prima dose dell'intervento in studio.
  • Deve accettare di evitare l'esposizione prolungata al sole e di astenersi dall'uso di cabine abbronzanti, lampade solari e altre fonti di luce ultravioletta durante lo studio

Criteri di esclusione:

  • Hanno avuto una riacutizzazione clinicamente significativa della psoriasi durante le 12 settimane precedenti al basale, come valutato dallo sperimentatore.
  • Avere una storia di psoriasi eritrodermica, psoriasi pustolosa generalizzata o localizzata, prevalentemente psoriasi guttata o psoriasi indotta o esacerbata da farmaci.
  • Avere qualsiasi diagnosi nota o sospetta di condizioni infiammatorie diverse dalla psoriasi e dall'artrite psoriasica, incluse ma non limitate a artrite reumatoide, sarcoidosi, IBD (morbo di Crohn o colite ulcerosa) o lupus eritematoso sistemico.
  • Hanno una diagnosi di artrite psoriasica che richiede, o stanno attualmente ricevendo, un trattamento medico immunosoppressore sistemico (inclusi corticosteroidi, immunosoppressori e farmaci biologici).
  • Avere un'infezione acuta attiva attuale o recente. Il partecipante non deve presentare sintomi o segni di infezione confermata o sospetta e deve aver completato qualsiasi trattamento antinfettivo appropriato per almeno 30 giorni prima dello screening e fino alla randomizzazione/basale.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: LY4100511 200 mg BID
Participants received LY4100511 200 milligrams (mg) administered orally twice daily (BID) for 12 weeks.
Droga: LY4100511
Somministrato per via orale
Sperimentale: LY4100511 400 mg BID
Participants received LY4100511 400 mg administered orally BID for 12 weeks.
Droga: LY4100511
Somministrato per via orale
Sperimentale: LY4100511 800 mg QD
Participants received LY4100511 800 mg administered orally once daily (QD) for 12 weeks, with matching placebo administered in the evening.
Droga: LY4100511
Somministrato per via orale
Comparatore placebo: Placebo BID
Participants received placebo administered orally BID for 12 weeks.
Droga: Placebo
Somministrato per via orale

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 Versus Placebo)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Investigatori

  • Direttore dello studio: 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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 ottobre 2024

Completamento primario (Effettivo)

24 luglio 2025

Completamento dello studio (Effettivo)

4 settembre 2025

Date di iscrizione allo studio

Primo inviato

16 settembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

16 settembre 2024

Primo Inserito (Effettivo)

19 settembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 18845
  • J5C-MC-FOAB (Altro identificatore: DCE853201)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

I dati anonimizzati a livello di singolo paziente verranno forniti in un ambiente di accesso sicuro previa approvazione di una proposta di ricerca e un accordo di condivisione dei dati firmato.

Periodo di condivisione IPD

I dati sono disponibili 6 mesi dopo la pubblicazione primaria e l'approvazione dell'indicazione studiata negli Stati Uniti e nell'Unione Europea (UE), a seconda di quale data sia successiva. I dati saranno disponibili per la richiesta a tempo indeterminato.

Criteri di accesso alla condivisione IPD

la proposta di ricerca deve essere approvata da un comitato di revisione indipendente e i ricercatori devono firmare un accordo di condivisione dei dati.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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