An exploratory study to investigate the bioavailability andpharmacodynamics of Dupilumab in dermal interstitial fluid od atopic dermatitis
- Conditions
- atopic dermatitis
- Registration Number
- DRKS00023872
- Lead Sponsor
- Medizinische Universität Graz, Abteilung für Endokrinologie und Diabetologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Key inclusion criteria:
- Male and female atopic dermatitis patients 18 – 65 years of age
- Patients diagnosed for at least 6 months before enrollment, with moderate-to-severe atopic dermatitis (AD) (EASI >16; IGA =3, as specified below and not adequately controlled by topical medication(s)
- At least one suitable lesion, which is well accessible for OFM investigation.
Key exclusion criteria
- Pregnant and breast feeding women and women of child-bearing potential unwilling to use effective contraception during the study
- History of or ongoing, chronic or recurrent infectious disease, or known tuberculosis infection as orally stated by the subject; History of Hepatitis B or C or HIV, tested via serum
- Planned administration of live vaccines during the study period or 6 weeks prior to enrolment
- Any other active dermatoses in need of systemic treatment
- Ongoing use of concomitant AD treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to Investigational and reference therapy
- Further: Excessive sun exposure, uncontrolled systemic disease and ongoing infections
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the pharmacodynamic effect of 16 week dupilumab treatment on inflammatory cytokine and chemokine levels in dermal interstitial fluid (ISF) of lesional and non-lesional skin and blood of AD patients in correlation to its clinical treatment effect assessed by clinical scores.
- Secondary Outcome Measures
Name Time Method 1) To investigate the effect of dupilumab treatment on eicosanoids in dermal ISF of atopic lesional and non-lesional skin in correlation to its clinical treatment effect.<br>2) To investigate the effect of 16-week dupilumab treatment on local immune-cell population in dermal ISF of atopic lesional and non-lesional skin in correlation to its clinical treatment effect.<br>3) To investigate the effect of dupilumab treatment on the metabolomic profile in blood and ISF from lesional and non-lesional atopic skin in correlation to its clinical treatment effect.<br>4) To investigate the changes in gene expression in the skin biopsy specimen and ISF after 16 weeks of dupilumab treatment and to relate these changes to inflammatory biomarkers and immune cell pattern in ISF