A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis

Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject. IGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline IGA as covariates.

Time frame: Week 16

Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS.

An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.

Time frame: Up to week 20

Population: Safety Set included all subjects who received at least one dose of study medication. Subjects were analyzed according to treatment received. The safety analyses were based on safety sets (SAF).

Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. EASI50 response is defined as achieving ≥ 50% improvement (reduction) in EASI score compared to baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates

Time frame: Week 2, Week 4, Week 6, Week 8, Week 12, Week 16

Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS

Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. EASI75 response is defined as achieving ≥ 75% improvement (reduction) in EASI score compared to baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates

Time frame: Week 2, Week 4, Week 6, Week 8, Week 12, Week 16

Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS

Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject. IGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline IGA as covariates.

Time frame: Week 2, Week 4, Week 6, Week 8, Week 12

Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS

Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.

Time frame: Baseline, Week 16

Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS

Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.

Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12

Population: Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS