This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis suffering from pruritus, who require systemic treatment of the disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigator Site
Hanover, Germany
Novartis Investigative Site
Kiel, Germany
Novartis Investigative Site
Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS)
Time frame: 2 weeks
Evaluate the therapeutic benefit from the patient's perspective of DNK333 to reduce pruritus as assessed by the Patient Benefit Index for Pruritus (PBIfP)
Time frame: 2 weeks
Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI)
Time frame: 2 weeks
Safety and tolerability of DNK333 in atopic dermatitis patients
Time frame: 2 weeks
the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333.
Time frame: 2 weeks
Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score.
Time frame: 2 weeks
Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state.
Time frame: 2 weeks
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25 mg placebo oral
100 mg oral
100 mg placebo oral
4 mg oral
1 mg oral
1 mg placebo oral
Münster, Germany