Dermatitis, AtopicNCT04878770
NMF-CsA-Dupi Trial
A study testing Topical corticosteroids, Systemic cyclosporine and Systemic dupilumab in people with Dermatitis, Atopic, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Topical corticosteroids, Systemic cyclosporine and Systemic dupilumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Aug 2021to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC - Sophia Children's Hospital
Rotterdam, South Holland
prof. S.G.M.A. Pasmans, MD PhD
About this study
Official title: 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.
- Conditions
- Dermatitis, Atopic
- Being tested
- Topical corticosteroids, Systemic cyclosporine, Systemic dupilumab
- Keywords
- natural moisturizing factor, systemic treatment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical corticosteroidsDrug
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 cyclosporineDrug
Also called Neoral
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.
Systemic dupilumabDrug
Also called DUPIXENT
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.
| Study group | Role | What they receive |
|---|---|---|
| Topical corticosteroids (control) | Active comparator | This group will receive topical corticosteroids. Receives: Drug: Topical corticosteroids |
| Systemic cyclosporine | Active comparator | This group will receive topical corticosteroids and systemic cyclosporin. Receives: Drug: Topical corticosteroids; Drug: Systemic cyclosporine |
| Systemic dupilumab | Active comparator | his group will receive topical corticosteroids and systemic dupilumab. Receives: Drug: Topical corticosteroids; Drug: Systemic dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
EASI
Change from baseline Eczema Area and Severity Index (0-72) over the course of 6 months, with higher scores meaning worse outcomes.
Measured: t = 0, 1 month, 2 months, 3 months and 6 months
Secondary outcomes (6)
EASI75
Relative reduction of 75% from baseline EASI without the use of rescue medication
Measured: t = 1 month, 2 months, 3 months and 6 months
IGA 0 or IGA 1
Proportion of patients that achieved IGA 0 or IGA 1 (Investigator's Global Assessment) without the use of rescue medication.
Measured: t = 0, 1 month, 2 months, 3 months and 6 months
NRS-11 reduction for itch ≥ 4 points
Proportion of patients that achieved a reduction ≥4 points on the Numeric Rating Scale-11 (0-10) for itch intensity.
Measured: t = 0, 1 month, 2 months, 3 months and 6 months
POEM
Change from baseline in Patient-Oriented Eczema Measure questionnaire (0-28) over the course of 6 months, with higher scores meaning worse outcomes.
Measured: t = 0, 1 month, 2 months, 3 months and 6 months
SCORAD
Change from baseline in Scoring Atopic Dermatitis scale (0-103) over the course of 6 months, with higher scores meaning worse outcomes.
Measured: t = 0, 1 month, 2 months, 3 months and 6 months
RECAP
Change from baseline in the Recap of Atopic Eczema questionnaire (0-28) over the course of 6 months, with higher scores meaning worse outcomes.
Measured: t = 0, 1 month, 2 months, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start16 Aug 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a partially-blinded randomized controlled trial that investigates if NMF-biomarker status has an effect on the effectiveness of systemic treatment with CsA in children with moderate-to-severe AD. It also investigates whether stratification on the NMF biomarker results in an improvement of efficiency in the use of systemic treatment with CsA in the treatment of moderate-to-severe AD.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Suzanne G.M.A. Pasmans, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878770
- Sponsor's protocol ID
- MEC-2019-0568
- Other IDs
- 2019-003247-30, 2019
- Status last verified
- Aug 2021
- First submitted
- 29 Apr 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the NMF Biomarker as Predictive Diagnostic for Effective Use of Cyclosporine and Dupilumab in the Treatment of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04878770
- Acronym / sponsor ID
- MEC-2019-0568
- Conditions
- Dermatitis, Atopic
- Keywords
- natural moisturizing factor, systemic treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a partially-blinded randomized controlled trial that investigates if NMF-biomarker status has an effect on the effectiveness of systemic treatment with CsA in children with moderate-to-severe AD. It also investigates whether stratification on the NMF biomarker results in an improvement of efficiency in the use of systemic treatment with CsA in the treatment of moderate-to-severe AD.
| Arm | Type | Receives |
|---|---|---|
| Topical corticosteroids (control) | Active comparator | Drug: Topical corticosteroidsThis group will receive topical corticosteroids. |
| Systemic cyclosporine | Active comparator | Drug: Topical corticosteroids, Drug: Systemic cyclosporineThis group will receive topical corticosteroids and systemic cyclosporin. |
| Systemic dupilumab | Active comparator | Drug: Topical corticosteroids, Drug: Systemic dupilumabhis group will receive topical corticosteroids and systemic dupilumab. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical corticosteroidsTopical 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. | Drug | Systemic cyclosporine, Systemic dupilumab, Topical corticosteroids (control) |
| Systemic cyclosporineAlso: NeoralSystemic 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. | Drug | Systemic cyclosporine |
| Systemic dupilumabAlso: DUPIXENTDupilumab (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. | Drug | Systemic dupilumab |
Primary outcome
EASI
Time frame: 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.
6 secondary outcomes
EASI75
Time frame: t = 1 month, 2 months, 3 months and 6 months
IGA 0 or IGA 1
Time frame: t = 0, 1 month, 2 months, 3 months and 6 months
NRS-11 reduction for itch ≥ 4 points
Time frame: t = 0, 1 month, 2 months, 3 months and 6 months
POEM
Time frame: t = 0, 1 month, 2 months, 3 months and 6 months
SCORAD
Time frame: t = 0, 1 month, 2 months, 3 months and 6 months
RECAP
Time frame: t = 0, 1 month, 2 months, 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical corticosteroids, Systemic cyclosporine and Systemic dupilumab in people with Dermatitis, Atopic, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzanne G.M.A. Pasmans, Prof (+31 6 53524299, s.pasmans@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EASI (time frame: t = 0, 1 month, 2 months, 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.