Moderate to severe chronic plaque psoriasis
Conditions
Brief summary
Change from baseline to Week 12 in Psoriasis Area and Severity Index (PASI) score.
Detailed description
• Achievement of static physician’s global assessment (sPGA) score clear (0), almost clear (1) and ≥ 2 points improvement from baseline to each time point up to Week 12. • Change from baseline and ratio to baseline at each time point up to Week 16 in sPGA score., • Adverse events (AEs) leading to premature discontinuation of trial intervention. • Treatment-emergent AEs and serious adverse events (SAEs). • Change from baseline to each time point in: - Vital signs - Body weight - Clinical laboratory variables - 12-lead electrocardiogram (ECG) • Treatment-emergent marked abnormalities for: - Vital signs - Clinical laboratory variables - 12-lead ECG
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 12 in Psoriasis Area and Severity Index (PASI) score. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Achievement of static physician’s global assessment (sPGA) score clear (0), almost clear (1) and ≥ 2 points improvement from baseline to each time point up to Week 12. • Change from baseline and ratio to baseline at each time point up to Week 16 in sPGA score., • Adverse events (AEs) leading to premature discontinuation of trial intervention. • Treatment-emergent AEs and serious adverse events (SAEs). • Change from baseline to each time point in: - Vital signs - Body weight - Clinical laboratory variables - 12-lead electrocardiogram (ECG) • Treatment-emergent marked abnormalities for: - Vital signs - Clinical laboratory variables - 12-lead ECG | — |
Countries
Bulgaria, Romania