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Farmacocinetica, sicurezza ed efficacia di Nemolizumab nei partecipanti con dermatite atopica da moderata a grave

1 giugno 2026 aggiornato da: Galderma R&D

Uno studio clinico multicentrico, in aperto, a gruppo singolo per valutare la farmacocinetica, la sicurezza e l'efficacia di Nemolizumab (CD14152) in soggetti pediatrici (di età compresa tra 2 e 11 anni) con dermatite atopica da moderata a grave

Lo scopo di questo studio è valutare la farmacocinetica (PK), l'efficacia e la sicurezza di nemolizumab nei partecipanti pediatrici con dermatite atopica (AD) da moderata a grave.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

109

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

  • Danimarca
      • Hellerup, Danimarca, 2900
        • Galderma Investigational Site #6218
  • Polonia
      • Lodz, Polonia, 90-265
        • Galderma Investigational Site #5570
      • Ostrowiec Świętokrzyski, Polonia, 27-400
        • Galderma Investigational Site #6237
      • Rzeszów, Polonia, 35-055
        • Galderma Investigational Site #5495
      • Warsaw, Polonia, 02-953
        • Galderma Investigational Site #6262
      • Wroclaw, Polonia, 51-685
        • Galderma Investigational Site #6261
  • Spagna
      • Esplugues de Llobregat, Spagna, 0850
        • Galderma Investigational Site #5896
  • Stati Uniti
    • California
      • Fountain Valley, California, Stati Uniti, 92708-3701
        • Galderma Investigational Site #8636
      • San Diego, California, Stati Uniti, 92123-2746
        • Galderma Investigational Site #9937
      • Vista, California, Stati Uniti, 92083-6031
        • Galderma Investigational Site #9930
    • Florida
      • Coral Gables, Florida, Stati Uniti, 92083-6031
        • Galderma Investigational Site #9929
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46250-2041
        • Galderma Investigational Site #8142
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40217-1444
        • Galderma Investigational Site #8092
    • Michigan
      • Troy, Michigan, Stati Uniti, 48084-5260
        • Galderma Investigational Site #8155
      • West Bloomfield, Michigan, Stati Uniti, 48322
        • Galderma Investigational Site #8560
    • New York
      • Brooklyn, New York, Stati Uniti, 11203-2012
        • Galderma Investigational Site #8242
      • New York, New York, Stati Uniti, 10032-3729
        • Galderma Investigational Site #9938
    • Oklahoma
      • Norman, Oklahoma, Stati Uniti, 73069-6301
        • Galderma Investigational Site #8206
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19103-4708
        • Galderma Investigational Site #8255
    • Texas
      • Beaumont, Texas, Stati Uniti, 77706-3061
        • Galderma Investigational Site #9931
      • San Antonio, Texas, Stati Uniti, 78218-3128
        • Galderma Investigational Site #78218-3128
  • Ungheria
      • Budapest, Ungheria, 1036
        • Galderma Investigational Site #6147
      • Szeged, Ungheria, 6720
        • Galderma Investigational Site #5531

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 2 anni a 12 anni (Bambino)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • AD cronico che è stato documentato per almeno 6 mesi per i partecipanti di età compresa tra 2 e 6 anni e almeno 1 anno per i partecipanti di età compresa tra 7 e 11 anni prima della visita di screening e confermato secondo i criteri di consenso dell'American Academy of Dermatology al momento del visita di screening
  • Punteggio EASI >=16 sia allo screening che alle visite basali
  • Punteggio IGA >=3 sia allo screening che alle visite basali
  • Coinvolgimento AD >=10% della BSA sia allo screening che alle visite basali
  • Punteggio PP NRS di picco (massimo) di almeno 4,0 sia alle visite di screening che al basale
  • Accettare di applicare quotidianamente una crema idratante durante lo studio dalla visita di screening e generosamente secondo necessità; accettare di applicare un corticosteroide topico autorizzato (TCS) dalla visita di screening e durante lo studio come ritenuto appropriato dallo sperimentatore
  • Partecipante e caregiver disposti e in grado di rispettare tutti gli impegni di tempo e i requisiti procedurali del protocollo della sperimentazione clinica
  • Potrebbero essere applicati altri criteri di inclusione definiti dal protocollo

Criteri di esclusione:

  • Peso corporeo inferiore a 10 chilogrammi (kg)
  • Child in Care: un minore che è stato posto sotto il controllo o la protezione di un'agenzia, organizzazione, istituzione o entità da parte dei tribunali, del governo o di un ente governativo, agendo in conformità con i poteri loro conferiti dalla legge o dal regolamento
  • Partecipanti con una storia medica attuale di bronchite cronica
  • Necessità di una terapia di salvataggio per l'AD durante il periodo di run-in o che si prevede richieda una terapia di salvataggio entro 2 settimane dalla visita di riferimento
  • Risultati sierologici positivi per l'antigene di superficie dell'epatite B (HBsAg) o l'anticorpo centrale dell'epatite B (HBcAb), l'anticorpo dell'epatite C (HCV) con test di conferma positivo per l'HCV (esempio; reazione a catena della polimerasi [PCR]) o virus dell'immunodeficienza umana (HIV) anticorpi alla visita di screening
  • Storia di malattia linfoproliferativa, ipersensibilità (inclusa anafilassi) a un prodotto immunoglobulinico e intolleranza a corticosteroidi topici a bassa o media potenza
  • Immunosoppressione nota o sospetta
  • Partecipanti non disposti ad astenersi dall'utilizzare farmaci proibiti durante la sperimentazione clinica.
  • Potrebbero essere applicati altri criteri di esclusione definiti dal protocollo

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: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Coorte 2: partecipanti di età compresa tra 2 e 6 anni
I partecipanti di età compresa tra 2 e 6 anni riceveranno nemolizumab per 52 settimane.
Droga: Nemolizumab
I partecipanti riceveranno un'iniezione sottocutanea (SC) di 10, 20 o 30 milligrammi (mg) di nemolizumab, ogni 4 settimane (Q4W) per 52 settimane con una dose di carico di 20, 40 o 60 mg al giorno 1 in base al peso corporeo.
Altri nomi:
  • CD14152
Droga: Nemolizumab
I partecipanti riceveranno un'iniezione SC di 5, 10 o 15 mg di nemolizumab, Q4W per 52 settimane con una dose di carico di 10, 20 o 30 mg al giorno 1 in base al peso corporeo.
Altri nomi:
  • CD14152
Sperimentale: Coorte 1.1: partecipanti di età compresa tra 7 e 11 anni
I partecipanti di età compresa tra 7 e 11 anni riceveranno nemolizumab per 52 settimane.
Droga: Nemolizumab
I partecipanti riceveranno un'iniezione sottocutanea (SC) di 10, 20 o 30 milligrammi (mg) di nemolizumab, ogni 4 settimane (Q4W) per 52 settimane con una dose di carico di 20, 40 o 60 mg al giorno 1 in base al peso corporeo.
Altri nomi:
  • CD14152
Droga: Nemolizumab
I partecipanti riceveranno un'iniezione SC di 5, 10 o 15 mg di nemolizumab, Q4W per 52 settimane con una dose di carico di 10, 20 o 30 mg al giorno 1 in base al peso corporeo.
Altri nomi:
  • CD14152
Sperimentale: Coorte 1: partecipanti di età compresa tra 7 e 11 anni
I partecipanti di età compresa tra 7 e 11 anni riceveranno Nemolizumab per 52 settimane.
Droga: Nemolizumab
I partecipanti riceveranno un'iniezione sottocutanea (SC) di 10, 20 o 30 milligrammi (mg) di nemolizumab, ogni 4 settimane (Q4W) per 52 settimane con una dose di carico di 20, 40 o 60 mg al giorno 1 in base al peso corporeo.
Altri nomi:
  • CD14152
Droga: Nemolizumab
I partecipanti riceveranno un'iniezione SC di 5, 10 o 15 mg di nemolizumab, Q4W per 52 settimane con una dose di carico di 10, 20 o 30 mg al giorno 1 in base al peso corporeo.
Altri nomi:
  • CD14152

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Nemolizumab Serum Concentrations
Lasso di tempo: At Weeks 4, 8, 12, 16, 32 and 52
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
At Weeks 4, 8, 12, 16, 32 and 52
Apparent Total Body Clearance (Cl/F) of Nemolizumab
Lasso di tempo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time [AUC (0-inf)]. Individual nemolizumab.
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Apparent Volume of Distribution (Vd/F) of Nemolizumab
Lasso di tempo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Vd/F was calculated as dose divided by lambda_z *AUC(0-inf).
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Absorption Rate Constant (Ka) of Nemolizumab
Lasso di tempo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab
Lasso di tempo: Pre-dose at Weeks 4, 8, 12, and 16
Pre-dose at Weeks 4, 8, 12, and 16
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab
Lasso di tempo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Apparent Terminal Half-life (t1/2) of Nemolizumab
Lasso di tempo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Adverse Events Leading to Discontinuation and Serious Adverse Events (SAEs)
Lasso di tempo: Baseline through Week 52
AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug during the study. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. AEs Leading to study treatment withdrawal and AEs Leading to study withdrawal will also be reported.
Baseline through Week 52

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in EASI Score
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants Achieving 50 Percent (%), 75% or 90% Response From Baseline in EASI (EASI-50, EASI-75 and EASI-90)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis. EASI-50, EASI-75 and EASI-90 responders will be the participants who achieved greater than or equal to (>=) 50%, >=75% and >=90% overall improvement in EASI score respectively from baseline to Week 52.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants With Investigator's Global Assessment (IGA) Success Rate
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of AD. The Investigator reviewed the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Here, higher score indicates severe outcome. Success was defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >=2-points improvement from baseline. Number of participants with IGA success rate was reported for this outcome measure.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of PP NRS Score
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants With an Improvement of >= 4 From Baseline in Weekly Average of PP NRS
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Average Pruritus NRS Score
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of Average Pruritus NRS Score
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Sleep Disturbance NRS Score
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of Sleep Disturbance NRS Score
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants Receiving Any Rescue Therapy by Rescue Treatment
Lasso di tempo: From Baseline up to Week 52
Percentage of participants receiving any rescue therapy by rescue treatment was reported.
From Baseline up to Week 52
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease), a higher score indicated severe disease.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) For Participants >=4 Years of Age
Lasso di tempo: Baseline, Week 16 and Week 52
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer quality of life (QoL).
Baseline, Week 16 and Week 52
Change From Baseline in Infants' Dermatology Life Quality Index (iDLQI) Score For Participants Less Than (<) 4 Years of Age
Lasso di tempo: Baseline, Week 16 and Week 52
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer QoL.
Baseline, Week 16 and Week 52
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
Lasso di tempo: Baseline, Week 16 and Week 52
The POEM is a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease). A high score indicated poor QOL.
Baseline, Week 16 and Week 52
Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in PP NRS
Lasso di tempo: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in PP-NRS score was established using population point estimate of IC50, where IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in PP NRS.
Baseline up to Week 52
PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in EASI Score
Lasso di tempo: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in EASI score was established using population point estimate of IC50. Where, IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in EASI score.
Baseline up to Week 52
PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in IGA Score
Lasso di tempo: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in IGA score was established using the population point estimate of the slope parameter.
Baseline up to Week 52
Number of Participants With Positive Anti-Drug Antibody (ADA) for Nemolizumab
Lasso di tempo: Baseline, Week 16 and Week 52
ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
Baseline, Week 16 and Week 52

Collaboratori e investigatori

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

Sponsor

Galderma R&D

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)

24 giugno 2021

Completamento primario (Effettivo)

28 aprile 2025

Completamento dello studio (Effettivo)

28 aprile 2025

Date di iscrizione allo studio

Primo inviato

4 giugno 2021

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2021

Primo Inserito (Effettivo)

10 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 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

  • RD.06.SPR.118126

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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