Plaque Psoriasis Psoriatic Arthritis
Conditions
Sponsors
UCB Japan Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Must be at least 18 years of age - Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit - Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale - Subject is a candidate for systemic PSO therapy and/or phototherapy - Female subject of child bearing potential must be willing to use highly effective method of contraception
Exclusion criteria
Exclusion criteria: - Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic or recurrent chronic infections - Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection - Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection - Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study - Presence of active suicidal ideation or positive suicide behavior - Presence of moderately severe major depression or severe major depression - Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy 1. Psoriasis Area and Severity Index 90 (PASI90) response at Week 16 2. Investigator's Global Assessment (IGA) response at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy 1. PASI100 response at Week 16 2. PASI75 response at Week 4 3. Patient Symptom Diary response for itch at Week 16 4. Patient Symptom Diary response for pain at Week 16 5. Patient Symptom Diary response for scaling at Week 16 6. Scalp IGA response (Clear or Almost Clear with at least a 2-category improvement from Baseline) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline 7. PASI90 response at Week 12 8. PASI90 response at Week 52 9. IGA response at Week 12 10. IGA response at Week 52 11. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment 12. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment 13. Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment | — |
Countries
Europe, Japan, North America, Oceania
Outcome results
None listed