Psoriasis
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: *Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Day 1. *Participants with a Physician Global Assessment (PGA) score of mild (2) or moderate (3) at Screening and Day 1. *At Screening and Day 1, have plaque psoriasis covering 2%-15% (inclusive) of total body surface area (BSA) on the trunk and/or limbs.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: *other skin conditions that would interfere with the evaluation of psoriasis *history of herpes zoster or simplex *Infected with Mycobacterium tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy *Percentage of Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12 *Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 *Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 *Change From Baseline in PASI Scores at Week 14 and 16 *Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 *Percent Change From Baseline in PASI Scores at Week 14 and 16 *Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12 *Absolute PP-NRS Score at Week 14 and 16 *Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12 *Change From Baseline in PP-NRS Score at Week 14 and 16 *Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2 *Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2 *Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16 *Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 *Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs *Number of Participants With TEAEs by Severity *Number of Participants Who Discontinued From Study Due to Adverse Events *Number of Participants With Laboratory Abnormalities Meeting Specified Criteria *Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data *Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data *Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Da | — |
Countries
Europe, Japan, North America, Oceania
Contacts
Pfizer R&D Japan G.K.