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NMF-CsA-Dupi Trial

17. august 2021 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

318

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Nederland
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Nederland
        • Rekruttering
        • Erasmus MC - Sophia Children's Hospital
        • Ta kontakt med:
          • prof. S.G.M.A. Pasmans, MD PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

2 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Topical corticosteroids (control)
This group will receive topical corticosteroids.
Legemiddel: 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.
Aktiv komparator: Systemic cyclosporine
This group will receive topical corticosteroids and systemic cyclosporin.
Legemiddel: 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.
Legemiddel: 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.

Andre navn:
  • Neoral
Aktiv komparator: Systemic dupilumab
his group will receive topical corticosteroids and systemic dupilumab.
Legemiddel: 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.
Legemiddel: 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.
Andre navn:
  • DUPIXENT

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
EASI
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
EASI75
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
CDLQI ≥4 years
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Erasmus Medical Center

Samarbeidspartnere

ZonMw: The Netherlands Organisation for Health Research and Development

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. august 2021

Primær fullføring (Forventet)

1. januar 2024

Studiet fullført (Forventet)

1. januar 2025

Datoer for studieregistrering

Først innsendt

29. april 2021

Først innsendt som oppfylte QC-kriteriene

6. mai 2021

Først lagt ut (Faktiske)

7. mai 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2021

Sist bekreftet

1. august 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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