Atopic dermatitis
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: * Clinical diagnosis of Atopic Dermatitis for at least 3 months * Investigator's Global Assessment (IGA) Score of 2 or 3 * Eczema Area Severity Index (EASI) score of 3-21 * Body Surface Area (BSA) of 2-20% * Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more
Exclusion criteria
Exclusion criteria: Exclusion Criteria: * Other forms of dermatological diseases (other than atopic dermatitis) * Fitzpatrick skin type score greater than 5 * Clinically significant abnormal ECG, vital signs, and laboratory values * Infection with HBV, HCV, herpes zoster or tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy * Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6 * Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 * Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6S * Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit * Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit * Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6 * Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) * Number of Participants With Pre-defined Criteria For Vital Signs * Number of Participants With Laboratory Abnormalities * Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings * Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit * Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit * Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit * Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit * Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit * Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eo | — |
Countries
Europe, Japan, North America, Oceania
Contacts
Pfizer R&D Japan G.K.