Moderate to severe atopic dermatitis
Conditions
Brief summary
The incidence of treatment emergent adverse events., The incidence of serious adverse events and adverse events leading to discontinuation., The incidence of clinical abnormalities and change from baseline in clinical laboratory values, electrocardiogram (ECG) measurements, and vital signs.
Detailed description
Baseline, for efficacy endpoints, is defined as pre-dose Day 1 in the relevant qualifying Parent study: Response based on achieving the Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥ 2 points at all scheduled time points., Response based on achieving ≥ 50%, ≥ 75%, ≥ 90% and 100% improvement from baseline in the Eczema Area and Severity Index (EASI) total score (EASI-50, EASI-75, EASI-90) and EASI-100 at all scheduled time points., Response based on achieving an improvement ≥ 4 points from baseline in the severity of pruritus NRS at all scheduled time points., Change from baseline in the frequency of itching due to Atopic Dermatitis, Change from baseline of Patient Global Assessment (PtGA) at all scheduled time points., Change from baseline in the percentage Body Surface Area (BSA) affected at all scheduled time points., Change from baseline in Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI) at all scheduled time points., Change from baseline in Patient Oriented Eczema Measure (POEM) at all scheduled time points., Change from baseline in Hospital Anxiety and Depression Scale (HADS) at all scheduled time points., Change from baseline of EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) at all scheduled time points., Steroid-free days at all scheduled time points., Serum hsCRP levels at all scheduled time points., Change in height standard deviation score., The proportion of abnormal bone findings in knee MRI in adolescent subjects exposed to abrocitinib 100 mg and 200 mg QD
Interventions
DRUGPlacebo for Abrocitinib 100mg tablet
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of treatment emergent adverse events., The incidence of serious adverse events and adverse events leading to discontinuation., The incidence of clinical abnormalities and change from baseline in clinical laboratory values, electrocardiogram (ECG) measurements, and vital signs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline, for efficacy endpoints, is defined as pre-dose Day 1 in the relevant qualifying Parent study: Response based on achieving the Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥ 2 points at all scheduled time points., Response based on achieving ≥ 50%, ≥ 75%, ≥ 90% and 100% improvement from baseline in the Eczema Area and Severity Index (EASI) total score (EASI-50, EASI-75, EASI-90) and EASI-100 at all scheduled time points., Response based on achieving an improvement ≥ 4 points from baseline in the severity of pruritus NRS at all scheduled time points., Change from baseline in the frequency of itching due to Atopic Dermatitis, Change from baseline of Patient Global Assessment (PtGA) at all scheduled time points., Change from baseline in the percentage Body Surface Area (BSA) affected at all scheduled time points., Change from baseline in Dermatology Life Quality Index (DLQI) or Children's DLQI | — |
Countries
Hungary, Poland, Spain
Outcome results
None listed