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Uno studio per valutare la farmacocinetica, la sicurezza e l'efficacia di due dosi di bimekizumab nei partecipanti allo studio adolescenti con psoriasi a placche da moderata a grave (BE CONNECTED)

24 aprile 2026 aggiornato da: UCB Biopharma SRL

Uno studio multicentrico, in aperto, randomizzato per valutare la farmacocinetica, la sicurezza e l'efficacia di due dosi di bimekizumab nei partecipanti allo studio adolescenti con psoriasi a placche da moderata a grave

Lo scopo dello studio è valutare la farmacocinetica (PK) di bimekizumab somministrato per via sottocutanea (sc) in adolescenti con psoriasi a placche da moderata a grave (PSO).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

41

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
      • Calgary, Canada
        • Ps0020 50354
      • St. John's, Canada
        • Ps0020 50357
  • Germania
      • Frankfurt, Germania
        • Ps0020 40645
  • Polonia
      • Bialystok, Polonia
        • Ps0020 40626
      • Lodz, Polonia
        • Ps0020 40625
      • Rzeszów, Polonia
        • Ps0020 40396
      • Warsaw, Polonia
        • Ps0020 40335
      • Wroclaw, Polonia
        • Ps0020 40333
      • Wroclaw, Polonia
        • Ps0020 40334
  • Stati Uniti
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46250
        • Ps0020 50344
    • Texas
      • Cypress, Texas, Stati Uniti, 77433
        • Ps0020 50359

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

Da 12 anni a 17 anni (Bambino)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Il partecipante deve avere un'età compresa tra ≥12 e <18 anni al momento della firma del consenso/assenso informato secondo la normativa locale

  • - Il partecipante ha avuto una diagnosi di psoriasi a placche da moderata a grave (PSO) per almeno 3 mesi prima della visita di screening e:

    1. Superficie corporea (BSA) affetta da PSO ≥10%
    2. Punteggio Investigator's Global Assessment (IGA) ≥3 (su una scala da 0 a 4)
    3. Punteggio Psoriasis Area and Severity Index (PASI) ≥12 OR
    4. Punteggio PASI ≥10 più almeno 1 dei seguenti:

    io. Coinvolgimento facciale clinicamente rilevante ii. Coinvolgimento genitale clinicamente rilevante iii. Interessamento clinicamente rilevante di mani e piedi

  • Il partecipante deve essere candidato alla terapia PSO sistemica e/o alla foto/chemioterapia
  • Peso corporeo ≥30 kg e indice di massa corporea per percentile di età ≥5 al basale
  • Maschio o femmina Una partecipante di sesso femminile sarà idonea a partecipare se non è incinta, non sta allattando e una donna in età fertile (WOCBP) accetta di seguire la guida contraccettiva
  • In grado di dare/avere il/i genitore/i o il rappresentante legale a fornire il consenso/assenso informato firmato (se del caso)

Criteri di esclusione:

  • Il partecipante ha una presenza di PSO guttata, inversa, pustolosa o eritrodermica o altra condizione dermatologica che può influire sulla valutazione clinica della PSO
  • - Il partecipante ha una storia di malattia infiammatoria intestinale (IBD) o sintomi indicativi di IBD
  • Storia di tubercolosi attiva se non trattata con successo, tubercolosi latente se non trattata profilatticamente
  • Il partecipante ha un'infezione attiva o una storia di infezioni (come infezioni gravi, infezioni croniche, infezioni opportunistiche, infezioni insolitamente gravi)
  • Il partecipante presenta anomalie di laboratorio allo screening
  • - Il partecipante ha sperimentato un fallimento primario a uno o più modificatori della risposta biologica dell'interleuchina-17 (IL-17) O fallimento primario a più di 1 modificatore della risposta biologica diverso da un modificatore della risposta biologica IL-17
  • Presenza di ideazione suicidaria attiva o comportamento suicida positivo
  • Al partecipante è stata diagnosticata una grave depressione negli ultimi 6 mesi

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: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Bimekizumab Dose A
I partecipanti allo studio randomizzati in questo braccio riceveranno la dose A di bimekizumab (BKZ) in momenti prestabiliti durante lo studio.
Droga: bimekizumab
I partecipanti allo studio riceveranno bimekizumab somministrato per via sottocutanea (BKZ) in momenti prestabiliti durante lo studio.
Altri nomi:
  • UCB4940
  • BKZ
Sperimentale: Bimekizumab Dose B
I partecipanti allo studio randomizzati in questo braccio riceveranno la dose B di bimekizumab (BKZ) in momenti prestabiliti durante lo studio.
Droga: bimekizumab
I partecipanti allo studio riceveranno bimekizumab somministrato per via sottocutanea (BKZ) in momenti prestabiliti durante lo studio.
Altri nomi:
  • UCB4940
  • BKZ

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Plasma Concentration of Bimekizumab at Week 0
Lasso di tempo: Baseline (Week 0)
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 0. PK-PPS = Pharmacokinetic per-protocol set, IMP = investigational medicinal product.
Baseline (Week 0)
Plasma Concentration of Bimekizumab at Week 1
Lasso di tempo: Week 1
Blood samples were collected to determine the bimekizumab plasma concentration at Week 1.
Week 1
Plasma Concentration of Bimekizumab at Week 4
Lasso di tempo: Week 4
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 4.
Week 4
Plasma Concentration of Bimekizumab at Week 8
Lasso di tempo: Week 8
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 8.
Week 8
Plasma Concentration of Bimekizumab at Week 12
Lasso di tempo: Week 12
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 12.
Week 12
Plasma Concentration of Bimekizumab at Week 16
Lasso di tempo: Week 16
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 16.
Week 16
Plasma Concentration of Bimekizumab at Week 20
Lasso di tempo: Week 20
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 20.
Week 20
Plasma Concentration of Bimekizumab at Week 40
Lasso di tempo: Week 40
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 40.
Week 40
Plasma Concentration of Bimekizumab at Week 64
Lasso di tempo: Week 64
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 64.
Week 64
Plasma Concentration of Bimekizumab at Week 88
Lasso di tempo: Week 88
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 88.
Week 88
Plasma Concentration of Bimekizumab at Week 112
Lasso di tempo: Week 112
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 112.
Week 112
Plasma Concentration of Bimekizumab at Week 124
Lasso di tempo: Week 124
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 124.
Week 124
Plasma Concentration of Bimekizumab at Safety Follow up (SFU)
Lasso di tempo: Week 140 (SFU)
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 140 (SFU).
Week 140 (SFU)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Lasso di tempo: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. The last dose was given 4 weeks prior end of extension period.
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)]
Percentage of Participants With Serious Treatment-emergent Adverse Events
Lasso di tempo: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
An serious adverse event (SAE) must meet 1 or more of the following criteria: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. The data was rounded to one decimal place. The last dose was given 4 weeks prior end of extension period.
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation of Investigational Medicinal Product (IMP)
Lasso di tempo: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason. The last dose was given 4 weeks prior end of extension period.
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study
Lasso di tempo: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. This measure considers any TEAEs leading to withdrawal from the study. The last dose was given 4 weeks prior end of extension period.
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Exposure-adjusted Incidence Rates (EAIR) of Selected Safety Topics of Interest
Lasso di tempo: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Selected safety topics of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease [IBD], and injection site reactions) with onset occurring from day of first dose through 20 weeks after final dose of IMP adjusted by duration of participant exposure to IMP. The exposure-adjusted incidence rate (EAIR) is defined as the number of participants (n) with a specific AE adjusted for the exposure and was scaled to 100 participant-years. The last dose was given 4 weeks prior end of extension period.
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Change From Baseline in Vital Signs (Systolic and Diastolic Blood Pressure)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Blood pressure was measured in millimeters of mercury (mmHg).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Vital Signs (Pulse Rate)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Pulse rate was measured in beats per minute (beats/min).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Vital Signs (Temperature)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Temperature (oral, axillary, otic or non-contact forehead) was measured in degrees Celsius (°C).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Platelet Count)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Platelets was measured in number of platelets per liter (10^9/L).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Mean Corpuscular Hemoglobin)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Mean Corpuscular Volume)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Mean corpuscular volume was measured in femtolitres.
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Erythrocytes)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Hemoglobin)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Hemoglobin was measured in grams per liter.
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Hematocrit)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Hematocrit was measured in volume percentage (%) of red blood cells in the blood.
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Clinical Chemistry Parameters (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase was measured in units per liter.
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes was measured in number of white blood cells per liter (10^9/L).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Clinical Chemistry Parameters (Calcium, Potassium, Sodium, Blood Urea Nitrogen, Glucose (Nonfasting)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Calcium, potassium, sodium, blood urea nitrogen, and glucose (non fasting) was measured in millimoles per liter (mmol/L).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Clinical Chemistry Parameters (Creatinine, Total and Direct Bilirubin)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Creatinine and bilirubin was measured in micromols per liter (μmol/L).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Clinical Chemistry Parameters (Total Protein)
Lasso di tempo: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Total protein was measured in gram per liter (g/L)
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Height
Lasso di tempo: Baseline (Week 0), Weeks 16, 124
Growth assessment, as assessed by the change from Baseline in height.
Baseline (Week 0), Weeks 16, 124
Change From Baseline in Weight
Lasso di tempo: Baseline (Week 0), Weeks 16, 124
Growth assessment, as assessed by the change from Baseline in weight.
Baseline (Week 0), Weeks 16, 124
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Lasso di tempo: Week 16
Percentage of participants with PASI 90 response at Week 16 is reported. PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. This is scoring system that averages redness, thickness, and scaliness of psoriatic lesions(on a 0-4 scale), and weights resulting score by area of skin involved. Body divided into 4 areas:head, arms, trunk to groin, and legs to top of buttocks. Assignment of average score for redness, thickness, and scaling for each of 4 body areas with score of 0(none) to 4(very marked). Determining percentage of skin covered with psoriasis(PSO) for each of body areas and converting to 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved PSO area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum possible PASI score is 0=no disease, maximum score is 72=maximal disease. Data was rounded to one decimal place.
Week 16
Percentage of Participants With Investigator's Global Assessment (IGA) 0/1 (Clear [0]/Almost Clear [1] With at Least 2-category Improvement From Baseline) Response at Week 16
Lasso di tempo: Week 16
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline. The data was rounded to one decimal place.
Week 16
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 Response at Week 4
Lasso di tempo: Week 4
Percentage of participants with PASI75 response at Week 4 is reported. PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. This is scoring system that averages redness, thickness, and scaliness of psoriatic lesions (on a 0-4 scale), and weights resulting score by area of skin involved. Body divided into 4 areas:head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with PSO for each of body areas and converting to 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum possible PASI score is 0=no disease, maximum score is 72=maximal disease. Data was rounded to one decimal place.
Week 4
Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Prior to Investigational Medicinal Product (IMP) Administration
Lasso di tempo: Baseline (Week 0)
Anti-bimekizumab antibody (AbAb) detection prior to IMP administration. Anti-bimekizumab antibodies was measured using 3-tiered assay approach: screening assay, confirmatory assay, and titration assay. Antidrug antibody (ADAb) positive status: any sample that is positive screen and positive immunodepletion (regardless of availability of a titer value). ADAb negative status: any sample that is either negative screen, or positive screen and negative immunodepletion, and where the bimekizumab concentration is less than or equal to the drug tolerance limit of the validated ADAb assay. ADAb missing status: any sample that is either negative screen or positive screen and negative immunodepletion and where the bimekizumab concentration exceeds the validated ADAb assay drug tolerance limit.
Baseline (Week 0)
Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Following Investigational Medicinal Product (IMP) Administration
Lasso di tempo: From Baseline (Week 0, post-first dose) to Safety Follow-Up (Week 140)
Anti-bimekizumab antibody (AbAb) detection following IMP administration. Overall ADAb positive is defined as having at least one sample that is confirmed positive following the 1st dose of IMP to SFU (regardless of missing data). Overall ADAb negative is defined as having all samples reported as negative, or has only one missing/inconclusive sample, following the 1st dose of IMP to SFU. Overall ADAb missing if the study participant has more than one missing ADAb sample for any reason and all other available ADAb samples are negative. The data was rounded to one decimal place.
From Baseline (Week 0, post-first dose) to Safety Follow-Up (Week 140)
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Response at Week 16
Lasso di tempo: Baseline, Week 16
The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week, (ie, over the last 7 days). The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol).
Baseline, Week 16

Collaboratori e investigatori

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

Sponsor

UCB Biopharma SRL

Investigatori

  • Direttore dello studio: UCB Cares, 001 844 599 2273

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)

6 aprile 2021

Completamento primario (Effettivo)

12 marzo 2025

Completamento dello studio (Effettivo)

12 marzo 2025

Date di iscrizione allo studio

Primo inviato

18 gennaio 2021

Primo inviato che soddisfa i criteri di controllo qualità

18 gennaio 2021

Primo Inserito (Effettivo)

22 gennaio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PS0020
  • 2020-001724-34 (Numero EudraCT)
  • 2023-509832-24 (Identificatore di registro: EU Clinical Trials)
  • U1111-1303-1875 (Altro identificatore: World Health Organization (WHO))

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 di questo studio possono essere richiesti da ricercatori qualificati sei mesi dopo l'approvazione del prodotto negli Stati Uniti e/o in Europa, o l'interruzione dello sviluppo globale, e 18 mesi dopo il completamento dello studio. Gli investigatori possono richiedere l'accesso a dati anonimi a livello di singolo paziente e documenti di sperimentazione redatti che possono includere: set di dati pronti per l'analisi, protocollo di studio, modulo di segnalazione di casi annotati, piano di analisi statistica, specifiche del set di dati e rapporto di studio clinico. Prima dell'utilizzo dei dati, le proposte devono essere approvate da un comitato di revisione indipendente su www.Vivli.org e dovrà essere firmato un accordo di condivisione dei dati. Tutti i documenti sono disponibili solo in inglese, per un tempo prestabilito, tipicamente 12 mesi, su un portale protetto da password. Questo piano può cambiare se il rischio di reidentificare i partecipanti allo studio è ritenuto troppo alto dopo il completamento dello studio; in questo caso e per proteggere i partecipanti, i dati a livello di singolo paziente non sarebbero resi disponibili.

Periodo di condivisione IPD

I dati di questo studio possono essere richiesti da ricercatori qualificati sei mesi dopo l'interruzione dell'approvazione del prodotto negli Stati Uniti e/o in Europa o dell'interruzione dello sviluppo globale e 18 mesi dopo il completamento dello studio.

Criteri di accesso alla condivisione IPD

I ricercatori qualificati possono richiedere l'accesso a IPD anonimi e documenti di studio redatti che possono includere: set di dati grezzi, set di dati pronti per l'analisi, protocollo di studio, modulo di segnalazione del caso in bianco, modulo di segnalazione del caso con annotazioni, piano di analisi statistica, specifiche del set di dati e rapporto di studio clinico. Prima dell'utilizzo dei dati, le proposte devono essere approvate da un comitato di revisione indipendente su www.Vivli.org e sarà necessario eseguire un accordo di condivisione dei dati firmato. Tutti i documenti sono disponibili solo in inglese, per un tempo prestabilito, in genere 12 mesi, su un portale protetto da password.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

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

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

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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Sponsor e collaboratori

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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