En undersøgelse for at vurdere farmakokinetikken, sikkerheden og effektiviteten af to doser bimekizumab hos unge deltagere i undersøgelsen med moderat til svær plakpsoriasis (BE CONNECTED)
30. juli 2026 opdateret af: UCB Biopharma SRL
En multicenter, open-label, randomiseret undersøgelse til vurdering af farmakokinetikken, sikkerheden og effektiviteten af to doser bimekizumab hos unge undersøgelsesdeltagere med moderat til svær plakpsoriasis
Formålet med undersøgelsen er at vurdere farmakokinetikken (PK) af bimekizumab administreret subkutant (sc) hos unge med moderat til svær plakpsoriasis (PSO).
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
41
Fase
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Calgary, Canada
- Ps0020 50354
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St. John's, Canada
- Ps0020 50357
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46250
- Ps0020 50344
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Texas
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Cypress, Texas, Forenede Stater, 77433
- Ps0020 50359
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Bialystok, Polen
- Ps0020 40626
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Lodz, Polen
- Ps0020 40625
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Rzeszów, Polen
- Ps0020 40396
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Warsaw, Polen
- Ps0020 40335
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Wroclaw, Polen
- Ps0020 40333
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Wroclaw, Polen
- Ps0020 40334
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Frankfurt, Tyskland
- Ps0020 40645
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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
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Deltageren skal være ≥12 til <18 år på tidspunktet for underskrivelsen af det informerede samtykke/samtykke i henhold til lokal lovgivning
Deltageren har haft en diagnose af moderat til svær plakpsoriasis (PSO) i mindst 3 måneder forud for screeningsbesøget og:
- Kropsoverfladeareal (BSA) påvirket af PSO ≥10 %
- Investigator's Global Assessment (IGA) score ≥3 (på en skala fra 0 til 4)
- Psoriasis Area and Severity Index (PASI) score ≥12 ELLER
- PASI-score ≥10 plus mindst 1 af følgende:
jeg. Klinisk relevant ansigtsinddragelse ii. Klinisk relevant genital involvering iii. Klinisk relevant hånd- og fodinddragelse
- Deltager skal være kandidat til systemisk PSO-terapi og/eller foto-/kemoterapi
- Kropsvægt ≥30 kg og kropsmasseindeks for alderspercentil på ≥5 ved baseline
- Mand eller kvinde En kvindelig deltager vil være berettiget til at deltage, hvis hun ikke er gravid, ikke ammer, og en kvinde i den fødedygtige alder (WOCBP) accepterer at følge præventionsvejledningen
- I stand til at give/have forældre eller juridisk repræsentant give underskrevet informeret samtykke/samtykke (hvor det er relevant)
Ekskluderingskriterier:
- Deltageren har en tilstedeværelse af guttat, omvendt, pustulær eller erytrodermisk PSO eller anden dermatologisk tilstand, der kan påvirke den kliniske vurdering af PSO
- Deltageren har en historie med inflammatorisk tarmsygdom (IBD) eller symptomer, der tyder på IBD
- Anamnese med aktiv tuberkulose, medmindre den er behandlet med succes, latent TB, medmindre den er profylaktisk behandlet
- Deltageren har en aktiv infektion eller historie med infektioner (såsom alvorlig infektion, kroniske infektioner, opportunistiske infektioner, usædvanligt alvorlige infektioner)
- Deltageren har laboratorieabnormiteter ved screening
- Deltageren har oplevet primær svigt af en eller flere interleukin-17 (IL-17) biologiske responsmodifikatorer ELLER primære svigt af mere end 1 biologisk responsmodifikator bortset fra en IL-17 biologisk responsmodifikator
- Tilstedeværelse af aktive selvmordstanker eller positiv selvmordsadfærd
- Deltageren er blevet diagnosticeret med svær depression inden for de seneste 6 måneder
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: Ingen (Åben etiket)
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: Bimekizumab Dosis A
Studiedeltagere, der er randomiseret til denne arm, vil modtage bimekizumab (BKZ) dosis A på forudbestemte tidspunkter under undersøgelsen.
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Studiedeltagere vil modtage subkutant administreret bimekizumab (BKZ) på forudbestemte tidspunkter i løbet af undersøgelsen.
Andre navne:
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Eksperimentel: Bimekizumab Dosis B
Studiedeltagere randomiseret til denne arm vil modtage bimekizumab (BKZ) dosis B på forudspecificerede tidspunkter i løbet af undersøgelsen.
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Studiedeltagere vil modtage subkutant administreret bimekizumab (BKZ) på forudbestemte tidspunkter i løbet af undersøgelsen.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Plasma Concentration of Bimekizumab at Week 0
Tidsramme: Baseline (Week 0)
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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.
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Baseline (Week 0)
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Plasma Concentration of Bimekizumab at Week 1
Tidsramme: Week 1
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Blood samples were collected to determine the bimekizumab plasma concentration at Week 1.
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Week 1
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Plasma Concentration of Bimekizumab at Week 4
Tidsramme: Week 4
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Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 4.
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Week 4
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Plasma Concentration of Bimekizumab at Week 8
Tidsramme: Week 8
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Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 8.
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Week 8
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Plasma Concentration of Bimekizumab at Week 12
Tidsramme: Week 12
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Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 12.
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Week 12
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Plasma Concentration of Bimekizumab at Week 16
Tidsramme: Week 16
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Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 16.
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Week 16
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Plasma Concentration of Bimekizumab at Week 20
Tidsramme: Week 20
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Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 20.
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Week 20
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Plasma Concentration of Bimekizumab at Week 40
Tidsramme: Week 40
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Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 40.
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Week 40
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Plasma Concentration of Bimekizumab at Week 64
Tidsramme: Week 64
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Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 64.
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Week 64
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Plasma Concentration of Bimekizumab at Week 88
Tidsramme: Week 88
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Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 88.
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Week 88
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Plasma Concentration of Bimekizumab at Week 112
Tidsramme: Week 112
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Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 112.
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Week 112
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Plasma Concentration of Bimekizumab at Week 124
Tidsramme: Week 124
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Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 124.
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Week 124
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Plasma Concentration of Bimekizumab at Safety Follow up (SFU)
Tidsramme: Week 140 (SFU)
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Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 140 (SFU).
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Week 140 (SFU)
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Tidsramme: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)]
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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.
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From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)]
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Percentage of Participants With Serious Treatment-emergent Adverse Events
Tidsramme: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
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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.
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From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation of Investigational Medicinal Product (IMP)
Tidsramme: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
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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.
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From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study
Tidsramme: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
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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.
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From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
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Exposure-adjusted Incidence Rates (EAIR) of Selected Safety Topics of Interest
Tidsramme: From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
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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.
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From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
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Change From Baseline in Vital Signs (Systolic and Diastolic Blood Pressure)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Blood pressure was measured in millimeters of mercury (mmHg).
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Vital Signs (Pulse Rate)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Pulse rate was measured in beats per minute (beats/min).
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Vital Signs (Temperature)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Temperature (oral, axillary, otic or non-contact forehead) was measured in degrees Celsius (°C).
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Hematology Parameters (Platelet Count)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Platelets was measured in number of platelets per liter (10^9/L).
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Hematology Parameters (Mean Corpuscular Hemoglobin)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Hematology Parameters (Mean Corpuscular Volume)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Mean corpuscular volume was measured in femtolitres.
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Hematology Parameters (Erythrocytes)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Erythrocytes was measured in number of red blood cells per liter (10^12/L).
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Hematology Parameters (Hemoglobin)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Hemoglobin was measured in grams per liter.
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Hematology Parameters (Hematocrit)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Hematocrit was measured in volume percentage (%) of red blood cells in the blood.
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Clinical Chemistry Parameters (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase was measured in units per liter.
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Hematology Parameters (Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes was measured in number of white blood cells per liter (10^9/L).
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Clinical Chemistry Parameters (Calcium, Potassium, Sodium, Blood Urea Nitrogen, Glucose (Nonfasting)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Calcium, potassium, sodium, blood urea nitrogen, and glucose (non fasting) was measured in millimoles per liter (mmol/L).
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Clinical Chemistry Parameters (Creatinine, Total and Direct Bilirubin)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Creatinine and bilirubin was measured in micromols per liter (μmol/L).
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Clinical Chemistry Parameters (Total Protein)
Tidsramme: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Total protein was measured in gram per liter (g/L)
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Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
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Change From Baseline in Height
Tidsramme: Baseline (Week 0), Weeks 16, 124
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Growth assessment, as assessed by the change from Baseline in height.
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Baseline (Week 0), Weeks 16, 124
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Change From Baseline in Weight
Tidsramme: Baseline (Week 0), Weeks 16, 124
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Growth assessment, as assessed by the change from Baseline in weight.
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Baseline (Week 0), Weeks 16, 124
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Percentage of Participants With Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Tidsramme: Week 16
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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.
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Week 16
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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
Tidsramme: Week 16
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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.
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Week 16
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Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 Response at Week 4
Tidsramme: Week 4
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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.
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Week 4
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Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Prior to Investigational Medicinal Product (IMP) Administration
Tidsramme: Baseline (Week 0)
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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.
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Baseline (Week 0)
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Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Following Investigational Medicinal Product (IMP) Administration
Tidsramme: From Baseline (Week 0, post-first dose) to Safety Follow-Up (Week 140)
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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.
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From Baseline (Week 0, post-first dose) to Safety Follow-Up (Week 140)
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Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Response at Week 16
Tidsramme: Baseline, Week 16
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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).
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Baseline, Week 16
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: UCB Cares, 001 844 599 2273
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)
Studiestart
6. april 2021
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
12. marts 2025
Studieafslutning (Faktiske)
Studieafslutning
12. marts 2025
Datoer for studieregistrering
Først indsendt
Først indsendt
18. januar 2021
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
18. januar 2021
Først opslået (Faktiske)
Først opslået
22. januar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
3. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juli 2026
Sidst verificeret
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- PS0020
- 2020-001724-34 (EudraCT nummer)
- 2023-509832-24 (Registry Identifier: EU Clinical Trials)
- U1111-1303-1875 (Anden identifikator: World Health Organization (WHO))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Data fra dette forsøg kan anmodes om af kvalificerede forskere seks måneder efter produktgodkendelse i USA og/eller Europa, eller global udvikling afbrydes, og 18 måneder efter forsøgets afslutning.
Efterforskere kan anmode om adgang til anonymiserede individuelle data på patientniveau og redigerede forsøgsdokumenter, som kan omfatte: analyseklare datasæt, undersøgelsesprotokol, kommenteret caserapportformular, statistisk analyseplan, datasætspecifikationer og klinisk undersøgelsesrapport.
Forud for brug af dataene skal forslag godkendes af et uafhængigt bedømmelsespanel på www.Vivli.org
og en underskrevet aftale om datadeling skal udføres.
Alle dokumenter er kun tilgængelige på engelsk i et forudbestemt tidsrum, typisk 12 måneder, på en adgangskodebeskyttet portal.
Denne plan kan ændre sig, hvis risikoen for at genidentificere forsøgsdeltagere vurderes til at være for høj, efter at forsøget er afsluttet; i dette tilfælde og for at beskytte deltagerne ville individuelle data på patientniveau ikke blive gjort tilgængelige.
IPD-delingstidsramme
Data fra dette forsøg kan anmodes om af kvalificerede forskere seks måneder efter produktgodkendelse i USA og/eller Europa eller global udvikling er afbrudt, og 18 måneder efter forsøgets afslutning.
IPD-delingsadgangskriterier
Kvalificerede forskere kan anmode om adgang til anonymiseret IPD og redigerede undersøgelsesdokumenter, som kan omfatte: rå datasæt, analyseklare datasæt, undersøgelsesprotokol, blank caserapportformular, kommenteret caserapportformular, statistisk analyseplan, datasætspecifikationer og klinisk undersøgelsesrapport.
Forud for brug af dataene skal forslag godkendes af et uafhængigt bedømmelsespanel på www.Vivli.org
og en underskrevet aftale om datadeling skal udføres. Alle dokumenter er kun tilgængelige på engelsk i en forudbestemt periode, typisk 12 måneder, på en adgangskodebeskyttet portal.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- 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 .