This was a randomized, double-blind, placebo-controlled, parallel-group study to assess safety and efficacy of ZPL389 in subjects with moderate to severe atopic dermatitis with a total study duration up to 24 weeks
A screening period of up to 4 weeks was followed by a 16-week double blinded treatment period. After the end of treatment visit, subjects were offered the possibility of ongoing treatment in the extension study (CZPL389A2203E1/ NCT03948334), or of entering the 4 week treatment-free follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
293
once daily from baseline until week 16
ZPL389 3 mg oral powder; once daily from baseline to week 16
ZPL389 10 mg oral powder; once daily from baseline to week 16
Percentage of IGA Responders at Week 16
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
Percent Change From Baseline in EASI Score at Week 16
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
Percent Change From Baseline in EASI Score Over Time
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
Percentage of EASI50 Responders Over Time
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ZPL389 30 mg oral powder; once daily from baseline to week 16
ZPL389 50 mg oral powder; once daily from baseline to week 16
Novartis Investigative Site
Litchfield Park, Arizona, United States
Novartis Investigative Site
Fountain Valley, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Fairborn, Ohio, United States
Novartis Investigative Site
Greer, South Carolina, United States
...and 79 more locations
Time frame: Week 2, Week 4, Week 6, Week 8, Week 12, Week 16
Percentage of EASI75 Responders Over Time
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
Percentage of IGA Responders Over Time
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
Number of Patients With Adverse Events
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