Primary Objective: To investigate longitudinal variation of blood-based biomarkers, their integration with disease severity, comorbidities, their association with standard care and characterization of adequate and inadequate responders to standard…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate longitudinal variation of blood based biomarkers, their
integration with disease severity, comorbidities, their association with
standard care and characterization of adequate and inadequate responders to
standard care in a longitudinal observational study in subjects with
moderate-to-severe atopic dermatitis (AD).
Secondary outcome
• Investigator*s Global Assessment (IGA)1 score at all visits.
• Eczema Area and Severity Index (EASI)2 score at all visits.
• At least 50% reduction in EASI score (EASI50; yes/no) at all visits.
• Patient-Oriented Eczema Measure (POEM)3 score at all visits.
• Dermatology Life Quality Index (DLQI)4 at all visits.
• Numerical Rating Scale pruritus (NRS pruritus)5 score at all visits
• Monitoring asthma and rhinitis disease activity and medication.
Background summary
Atopic dermatitis (AD), a chronic inflammatory skin disease that often begins
in early infancy, is characterized clinically by pruritus, typical form, and
distribution of skin lesions, and a personal or familial history of atopic
diseases such as allergic asthma, allergic rhino conjunctivitis, and AD (1).
Various types of inflammatory cells have been shown to be involved in the
pathogenesis of atopic diseases. Patients suffering from atopic diseases often
show high blood eosinophil counts. Various cytokines and chemokines, such as
TARC, MDC, RANTES, eotaxin, IL-5, and IL-3, produced mainly by
antigen-presenting cells and T cells, attract inflammatory cells to the site of
the inflammation and activate them, leading to the release of several
pro-inflammatory mediators (2-4).
The value of blood based biomarkers in patients treated with systemic
immunosuppressants/biologics in AD has been explored to a limited extent. This
study will allow to gain more insight in AD through biomarker measurements.
Here, we*ll further investigate levels of multiple biomarkers in blood - serum,
whole blood, PBMCs and DNA - to determine if elevated levels of these
biomarkers in AD patients provide evidence to deconvolute disease complexity
and heterogeneity, are associated to disease progression and severity, are
associated with standard care and are able to characterize adequate and
inadequate responders to treatment.
Study objective
Primary Objective:
To investigate longitudinal variation of blood-based biomarkers, their
integration with disease severity, comorbidities, their association with
standard care and characterization of adequate and inadequate responders to
standard care in a longitudinal observational study in subjects with
moderate-to-severe atopic dermatitis (AD).
Secondary Objective(s):
To characterise changes in disease severity using patient- and
physician-reported outcome measures.
Study design
This study is a single-centre, uncontrolled, open-label, observational study
with a 24 week observation period. 260 subjects with moderate and severe AD
will be enrolled. Subjects will receive different treatments registered for
treatment of AD, including cyclosporine A, biologics (dupilumab and
tralokinumab), JAK-inhibitors (upadacitinib and abrocitinib).
Clinical parameters will be evaluated at baseline, at week 4, at week 12-16 and
week 24 after treatment initiation according to the regular follow up schedule.
Blood samples (for safety lab and for biomarker analyses) will be taken at
baseline, at week 4, at week 12-16 and week 24 after treatment initiation.
Study burden and risks
Risks
Cyclosporine A, dupilumab,tralokinumab and JAK-inhibitors (upadacitinib and
abrocitinib) is registered for the treatment of atopic dermatitis. Therefore
patients are not exposed to additional risks compared to patients treated
regularly with Cyclosporine A, dupilumab,tralokinumab and JAK-inhibitors
(upadacitinib and abrocitinib).
Burden:
Subjects will be asked to donate some additional blood (during regular safety
lab blood checks).
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Adult patients with moderate-to-severe atopic dermatitis
- An intention to start cyclosporine A, dupilumab, tralokinumab, oral
JAK-inhibitor (abrocitinib or upadacitinib) treatment according to the NVDV
guideline
- Documented recent history (last 6 months) of eligibility for treatment with
immunosuppressants, biologicals and JAK-inhibitors.
Exclusion criteria
- Children and adolescents (<18 years)
- men and women planning pregnancy during study, pregnant women and
breastfeeding women
- Patients with other inflammatory skin diseases, autoimmune diseases, or other
systemic
inflammatory diseases will be excluded (eg. psoriasis, diabetes mellitus,
inflammatory bowel
disease, rheumatoid arthrtitis).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80377.078.22 |