Plaque Psoriasis.
Conditions
Brief summary
Co-primary Endpoints: - Achievement of PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of sPGA clear or almost clear (0 or 1) at Week 16 of initial treatment
Detailed description
Ranked Secondary Endpoints: Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of sPGA clear or almost clear at (0 or 1) at Week 0 and Week 16 of the retreatment phase in Part 2., Non-ranked Secondary Efficacy Endpoints: Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 16 of initial treatment, Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 0 and Week 16 of the re-treatment phase in Part 2., Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2., Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2., Achievement of a PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2, Change in Children's Dermatology Life Quality Index (CDLQI) from Week 0 to Week 16 of initial treatment in Part 2, Change in CDLQI from Week 0 to Week 16 of re-treatment phase of Part 2, Change in Family Dermatology Life Quality Index (FDLQI) from Week 0 to Week 16 of initial treatment in Part 2, Change in FDLQI from Week 0 to Week 16 of re-treatment phase of Part 2, Change in Itch Numerical Rating Scale (Itch NRS) from Week 0 to Week 16 of initial treatment in Part 2, Change in Itch NRS from Week 0 to Week 16 of re-treatment phase in Part 2, Achievement of ≥ 4-point improvement from baseline in the Itch Numerical Rating Scale (in patients with Baseline score ≥ 4) at Week 16 of initial treatment in Part 2
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary Endpoints: - Achievement of PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of sPGA clear or almost clear (0 or 1) at Week 16 of initial treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Ranked Secondary Endpoints: Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of sPGA clear or almost clear at (0 or 1) at Week 0 and Week 16 of the retreatment phase in Part 2., Non-ranked Secondary Efficacy Endpoints: Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 16 of initial treatment, Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 0 and Week 16 of the re-treatment phase in Part 2., Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2., Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2., Achievement of a PASI 75 (defined as at least 75% impr | — |
Countries
Germany, Poland, Spain