This was a randomized, double blind, placebo controlled, parallel group study in approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12 and ≤ 48 (0-72 scale). Following a run-in subjects were randomized to receive either oral 30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
98
ZPL-3893787
Matched Placebo
Belgium Study Site
Brussels, Belgium
Belgium Study Site
Leuven, Belgium
Belgium Study Site
Liège, Belgium
Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)
The participant used the Pruritus NRS to rate his or her worst itch in the previous 12 hours. This was assessed twice daily (in the morning soon after rising and the evening prior to retiring) and recorded in the eDiary. The scale ranges from 0 (no itching) to 10 (itching as bad as can be imagined). If only 1 measurement was collected on a particular day, that score was counted as the worst measurement.
Time frame: Baseline to Week 8
Change From Baseline in Eczema Area and Severity Index (EASI) Score
The EASI is a validated tool used to measure the severity and extent of atopic eczema over 4 body regions (head and neck, upper limbs, trunk, and lower limbs). The intensity of a representative area of eczema and the approximate percentage affected by eczema are calculated for each region. A representative area of eczema is selected for each body region. The intensity of redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) of eczema is assessed as: 0 - None 1. \- Mild 2. \- Moderate 3. \- Severe The total score incorporates the extent of body regions affected. Scores range from 0 to 72 with higher scores indicating more severe eczema. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions
Time frame: Baseline to Week 8
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German Study Site
Goch, Germany
German Study Site
Hamburg, Germany
German Study Site
Hanover, Germany
German Study Site
Mainz, Germany
German Study Site
Münster, Germany
Polish Study Site
Bialystok, Poland
Polish Study Site
Gdansk, Poland
...and 7 more locations