Moderate to Severe Plaque Psoriasis
Conditions
Brief summary
Efficacy: Participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16., Efficacy: Participants achieving a sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16., Safety (LTE): AEs and SAEs through study completion., Safety (LTE): Monitoring of growth, including body weight and height and sexual maturation, through study completion.
Detailed description
Efficacy: Participants achieving at least 90% improvement in PASI (PASI 90) Week 16., Efficacy: Change from baseline in PASI at Week 16., Efficacy: Change from baseline in BSA involvement at Week 16., Safety: Treatment emergent AEs and SAEs, laboratory parameters, physical examination, and vital signs through study completion., Safety: Participants with protective titers of antibodies to measles, tetanus, and pertussis at Week 16., Safety: Monitoring of growth including body weight and height, and sexual maturation through study completion., Efficacy (LTE): Participants achieving 75% improvement in PASI (PASI 75) over time through study completion., Efficacy (LTE): Participants achieving an sPGA score of 0 (clear) or 1(almost clear) with at least a 2-point reduction from baseline over time through study completion.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16., Efficacy: Participants achieving a sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16., Safety (LTE): AEs and SAEs through study completion., Safety (LTE): Monitoring of growth, including body weight and height and sexual maturation, through study completion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Participants achieving at least 90% improvement in PASI (PASI 90) Week 16., Efficacy: Change from baseline in PASI at Week 16., Efficacy: Change from baseline in BSA involvement at Week 16., Safety: Treatment emergent AEs and SAEs, laboratory parameters, physical examination, and vital signs through study completion., Safety: Participants with protective titers of antibodies to measles, tetanus, and pertussis at Week 16., Safety: Monitoring of growth including body weight and height, and sexual maturation through study completion., Efficacy (LTE): Participants achieving 75% improvement in PASI (PASI 75) over time through study completion., Efficacy (LTE): Participants achieving an sPGA score of 0 (clear) or 1(almost clear) with at least a 2-point reduction from baseline over time through study completion. | — |
Countries
Belgium, Germany, Hungary, Italy, Poland, Romania, Spain