- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04878770
NMF-CsA-Dupi Trial
Use of the NMF Biomarker as Predictive Diagnostic for Effective Use of Cyclosporine and Dupilumab in the Treatment of Atopic Dermatitis
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Suzanne G.M.A. Pasmans, Prof
- Telefonnummer: +31 6 53524299
- E-post: s.pasmans@erasmusmc.nl
Studieorter
-
-
Zuid-Holland
-
Rotterdam, Zuid-Holland, Nederländerna
- Rekrytering
- Erasmus MC - Sophia Children's Hospital
-
Kontakt:
- prof. S.G.M.A. Pasmans, MD PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Topical corticosteroids (control)
This group will receive 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.
|
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.
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.
Andra namn:
|
Aktiv komparator: Systemic dupilumab
his group will receive topical corticosteroids and systemic dupilumab.
|
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.
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
EASI
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
EASI75
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
CDLQI ≥4 years
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hudsjukdomar
- Immunsystemets sjukdomar
- Överkänslighet, Omedelbar
- Genetiska sjukdomar, medfödda
- Hudsjukdomar, genetiska
- Överkänslighet
- Hudsjukdomar, eksem
- Dermatit
- Dermatit, atopisk
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Enzyminhibitorer
- Antireumatiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Dermatologiska medel
- Antifungala medel
- Calcineurin-hämmare
- Cyklosporin
- Cyklosporiner
Andra studie-ID-nummer
- MEC-2019-0568
- 2019-003247-30 (EudraCT-nummer)
Plan för individuella deltagardata (IPD)
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