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NMF-CsA-Dupi Trial

17 agosto 2021 aggiornato da: Suzanne G.M.A. Pasmans, Erasmus Medical Center

Use of the NMF Biomarker as Predictive Diagnostic for Effective Use of Cyclosporine and Dupilumab in the Treatment of Atopic Dermatitis

The goal of this study is to investigate whether stratification of children with atopic dermatitis on the NMF biomarkers results in an improvement of effectiveness and efficiency in the use of systemic treatment (ciclosporin and dupilumab) in moderate-to-severe atopic dermatitis.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Anticipato)

318

Fase

  • Non applicabile

Contatti e Sedi

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

Contatto studio

Luoghi di studio

  • Olanda
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Olanda
        • Reclutamento
        • Erasmus MC - Sophia Children's Hospital
        • Contatto:
          • prof. S.G.M.A. Pasmans, MD PhD

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 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Children and adolescents, aged 2-18 years, with moderate-to-severe atopic dermatitis (diagnosed according to the UK working party criteria)
  • Patient and parents/guardians able to participate in the study and willing to give written informed consent
  • EASI (Eczema Area Severity Index) ≥ 6 at screening and baseline (corresponding with moderate-to-severe disease)
  • IGA (Investigator Global Assessment) ≥ 3 at screening and baseline (corresponding with moderate-to-severe disease)

Exclusion Criteria:

  • Children under the age of 2 years and patients older than 18 years
  • Contraindication for ciclosporin
  • Contraindication for dupilumab
  • Patient (or one of the parents/guardians) not willing to be randomized
  • Children with a history of any known primary immunodeficiency disorder
  • Children with a history of cancer
  • EASI < 6 at screening or baseline
  • IGA < 3 at screening or baseline

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: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Topical corticosteroids (control)
This group will receive topical corticosteroids.
Droga: Topical corticosteroids
Topical corticosteroids (TCS) are registered for patients of all ages, and are together with emollients, the pillars in the basic treatment of atopic dermatitis. In this study, patients in both the intervention groups and control group are treated with daily emollients and a TCS of moderate to high potency if needed. Rescue medication with TCS of higher potency may be prescribed if basic therapy is inadequate in controlling AD symptoms.
Comparatore attivo: Systemic cyclosporine
This group will receive topical corticosteroids and systemic cyclosporin.
Droga: Topical corticosteroids
Topical corticosteroids (TCS) are registered for patients of all ages, and are together with emollients, the pillars in the basic treatment of atopic dermatitis. In this study, patients in both the intervention groups and control group are treated with daily emollients and a TCS of moderate to high potency if needed. Rescue medication with TCS of higher potency may be prescribed if basic therapy is inadequate in controlling AD symptoms.
Droga: Systemic cyclosporine

Systemic cyclosporine A (CsA) is an immunosuppressive therapy and is a registered treatment for AD in adults. According to national guidelines, CsA is the first choice for systemic treatment in children with moderate-to-severe AD.

For CsA a starting dose of 4-5mg/kg/day is administered orally and then tapered down to 2-3mg/kg/day depending on clinical effect. Two doses will be taken at two fixed times per day. Treatment with systemic CsA will be continued for a total of 6 months.

Altri nomi:
  • Neorale
Comparatore attivo: Systemic dupilumab
his group will receive topical corticosteroids and systemic dupilumab.
Droga: Topical corticosteroids
Topical corticosteroids (TCS) are registered for patients of all ages, and are together with emollients, the pillars in the basic treatment of atopic dermatitis. In this study, patients in both the intervention groups and control group are treated with daily emollients and a TCS of moderate to high potency if needed. Rescue medication with TCS of higher potency may be prescribed if basic therapy is inadequate in controlling AD symptoms.
Droga: Systemic dupilumab
Dupilumab (DUPIXENT) is indicated for the treatment of children of 6 years and older with moderate-to-sever atopic dermatitis whos disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. rm: Active Comparator: Systemic dupilumab Dupilumab (DUPIXENT) is administered as a solution by subdermal injection according to national guidelines, based on age and body weight.
Altri nomi:
  • DUPIXENTE

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
EASI
Lasso di tempo: t = 0, 1 month, 2 months, 3 months and 6 months
Change from baseline Eczema Area and Severity Index (0-72) over the course of 6 months, with higher scores meaning worse outcomes.
t = 0, 1 month, 2 months, 3 months and 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
EASI75
Lasso di tempo: t = 1 month, 2 months, 3 months and 6 months
Relative reduction of 75% from baseline EASI without the use of rescue medication
t = 1 month, 2 months, 3 months and 6 months
IGA 0 or IGA 1
Lasso di tempo: t = 0, 1 month, 2 months, 3 months and 6 months
Proportion of patients that achieved IGA 0 or IGA 1 (Investigator's Global Assessment) without the use of rescue medication.
t = 0, 1 month, 2 months, 3 months and 6 months
NRS-11 reduction for itch ≥ 4 points
Lasso di tempo: t = 0, 1 month, 2 months, 3 months and 6 months
Proportion of patients that achieved a reduction ≥4 points on the Numeric Rating Scale-11 (0-10) for itch intensity.
t = 0, 1 month, 2 months, 3 months and 6 months
POEM
Lasso di tempo: t = 0, 1 month, 2 months, 3 months and 6 months
Change from baseline in Patient-Oriented Eczema Measure questionnaire (0-28) over the course of 6 months, with higher scores meaning worse outcomes.
t = 0, 1 month, 2 months, 3 months and 6 months
SCORAD
Lasso di tempo: t = 0, 1 month, 2 months, 3 months and 6 months
Change from baseline in Scoring Atopic Dermatitis scale (0-103) over the course of 6 months, with higher scores meaning worse outcomes.
t = 0, 1 month, 2 months, 3 months and 6 months
RECAP
Lasso di tempo: t = 0, 1 month, 2 months, 3 months and 6 months
Change from baseline in the Recap of Atopic Eczema questionnaire (0-28) over the course of 6 months, with higher scores meaning worse outcomes.
t = 0, 1 month, 2 months, 3 months and 6 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
CDLQI ≥4 years
Lasso di tempo: t = 0, 3 months and 6 months
Children's Dermatology Life Quality Index, in the context of a cost-effectiveness analysis
t = 0, 3 months and 6 months
IDQoL <4 years
Lasso di tempo: t = 0, 3 months and 6 months
Infants' Dermatitis Quality of Life Index, in the context of a cost-effectiveness analysis
t = 0, 3 months and 6 months
Emollients and steroid use in frequency and tubes used
Lasso di tempo: t = 0, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
In context of a cost-effectiveness analysis: To assess the use of topical medication, including emollients, expressed in number of grams and/or used tubes, and changes therein during systemic treatment.
t = 0, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
Healthcare costs related to the treatment of AD
Lasso di tempo: Over the course of 6 months
In context of a cost-effectiveness analysis: To assess medical specialist care, hospitalization, medication, and other costs directly associated with the treatment and recurrence.
Over the course of 6 months
Adverse events
Lasso di tempo: Over the course of 6 months
Adverse events related to therapy as reported at any time during treatment by patient, custodian or investigator.
Over the course of 6 months
NMF measured via Raman spectroscopy
Lasso di tempo: t = - 2 weeks, 0, 3 months and 6 months
Natural Moisturizing Factor, to acquire more knowledge about external and internal factors that influence the NMF biomarker
t = - 2 weeks, 0, 3 months and 6 months
Microbiome profile
Lasso di tempo: t = 0, 3 months and 6 months
To investigate differences in microbiome profiles between patients with normal vs low NMF, and to investigate changes from baseline in microbiome profile during treatment, periodic swabs of nose, lesional skin, non-lesional skin and faeces will be obtained from patients.
t = 0, 3 months and 6 months
Humoral blood panel (systemic arms)
Lasso di tempo: t = 0, 1 month, 3 months and 6 months
Changes in IgE during systemic treatment over the course of 6 months.
t = 0, 1 month, 3 months and 6 months
Humoral blood panel (topical arm)
Lasso di tempo: t = 0 and 6 months
Changes in IgE during topical treatment over the course of 6 months.
t = 0 and 6 months
Cellular blood panel (systemic arm)
Lasso di tempo: t = 0, 1 month, 3 months and 6 months
Changes in leucocyte differentiation during systemic treatment over the course of 6 months.
t = 0, 1 month, 3 months and 6 months
FLG null mutations
Lasso di tempo: t = 0
Genotyping on skin barrier proteins, to acquire more knowledge about external and internal factors that influence atopic dermatitis and the NMF biomarker
t = 0
Activity of atopy
Lasso di tempo: t = 0, 3 months and 6 months
The activity of rhinoconjunctivitis, asthma and food allergy examined by a pediatric allergist and pediatric pulmonologist.
t = 0, 3 months and 6 months
Psychosocial factors (CBCL)
Lasso di tempo: t = 0
To investigate the influence of psychosocial factors in the patient on pediatric atopic dermatitis as assessed by the CBCL (Child Behaviour Checklist). Patients are assessed by questions grouped in empirically based syndrome scales: Aggressive Behavior, Anxious/Depressed, Attention Problems, Rule-Breaking Behavior, Somatic Complaints, Social Problems, Thought Problems, Withdrawn/Depressed. Higher percentile scores per scale indicate worse outcomes.
t = 0
Psychosocial factors (OBVL)
Lasso di tempo: t = 0
To investigate the influence of psychosocial factors in the family on pediatric atopic dermatitis as assessed by the OBVL (OpvoedingsBelastingVragenLijst / Parenting Stress Questionnaire), with higher percentile scores indicating worse outcomes
t = 0

Collaboratori e investigatori

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

Sponsor

Erasmus Medical Center

Collaboratori

ZonMw: The Netherlands Organisation for Health Research and Development

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)

16 agosto 2021

Completamento primario (Anticipato)

1 gennaio 2024

Completamento dello studio (Anticipato)

1 gennaio 2025

Date di iscrizione allo studio

Primo inviato

29 aprile 2021

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2021

Primo Inserito (Effettivo)

7 maggio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 agosto 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 agosto 2021

Ultimo verificato

1 agosto 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MEC-2019-0568
  • 2019-003247-30 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

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

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli 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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