Atopic Dermatitis
Conditions
Brief summary
Part A: Percent Change from Baseline in Eczema Area and Severity Index (EASI) [Time Frame: Baseline and at Week 16] Part B: Proportion of patients who achieve EASI 75 at Week 16
Detailed description
Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to 106 Weeks], Change from Baseline in EASI [Time Frame: Baseline, through Week 16 and at Week 52], Percent Change from Baseline in EASI [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >=2-Point Reduction [Time Frame: Baseline through Week 16 and at Week 52], Change from Baseline in BSA Involvement [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving a >=4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS) [Time Frame: Baseline through Week 16 and at Week 52], Percent Change from Baseline in the Weekly Mean of the Daily I-NRS [Time Frame: Baseline through Week 16 and at Week 52], Serum Concentrations of APG777 Over Time [Time Frame: Up to 106 Weeks], Predose Serum Concentrations of APG777 (Ctrough) [Time Frame: Up to 106 Weeks], Maximum concentration (Cmax) of APG777 [Time Frame: Up to 106 Weeks], Time to reach Cmax (tmax) [Time Frame: Up to 106 Weeks], Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period [Time Frame: Baseline to 16 Weeks], AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period [Time Frame: 16 Weeks to 52 Weeks]
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Percent Change from Baseline in Eczema Area and Severity Index (EASI) [Time Frame: Baseline and at Week 16] Part B: Proportion of patients who achieve EASI 75 at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to 106 Weeks], Change from Baseline in EASI [Time Frame: Baseline, through Week 16 and at Week 52], Percent Change from Baseline in EASI [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >=2-Point Reduction [Time Frame: Baseline through Week 16 and at Week 52], Change from Baseline in BSA Involvement [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving a >=4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS) [Time Frame: Baseline through Week 16 and at Week 52], Percent Change from Baseline in the Weekly Mean of the Daily I-NRS [Time Frame: Baseline through W | — |
Countries
Czechia, France, Germany, Hungary, Poland, Spain