Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16 |
Percentage of participants who achieve ppPASI75 response, defined as improvement greater than or equal to (>=) 75 percent (%) in the ppPASI score at Week 16 will be reported. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles. |
Week 16 |
|
| Secondary |
Change from Baseline in Body Surface Area (BSA) Score at Weeks 16, 24 and 48 |
Change from baseline in BSA score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups by measuring the arithmetic mean of the affected skin surface. |
Baseline and Weeks 16, 24 and 48 |
|
| Secondary |
Change from Baseline in absolute PASI Score at Weeks 16, 24 and 48 |
Change from baseline in absolute PASI score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. |
Baseline, Weeks 16, 24 and 48 |
|
| Secondary |
Percentage of Participants Achieving PASI 75 Score at Weeks 16, 24 and 48 |
Percentage of participants achieving PASI 75 score (participants who achieve >=75% improvement in PASI score) at Weeks 16, 24 and 48 will be reported in guselkumab versus the placebo group. PASI is a common clinical tool used to measure the severity and extent of psoriasis. The PASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles. |
Weeks 16, 24 and 48 |
|
| Secondary |
Percentage of Participants Achieving PASI 90 Score at Weeks 16, 24 and 48 |
Percentage of participants achieving PASI 90 score (participants who achieve >=90 % improvement in PASI score) at Weeks 16, 24 and 48 will be reported in guselkumab versus the placebo group. PASI is a common clinical tool used to measure the severity and extent of psoriasis. The PASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles. |
Weeks 16, 24 and 48 |
|
| Secondary |
Percentage of Participants Achieving PASI 100 at Weeks 16, 24 and 48 |
Percenatge of participants who achieving PASI 100 score (participants who achieve >=100 % improvement in PASI score) at Weeks 16, 24 and 48 will be reported in guselkumab versus the placebo group. PASI is a common clinical tool used to measure the severity and extent of psoriasis. The PASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles. |
Weeks 16, 24 and 48 |
|
| Secondary |
Change from Baseline in Palmoplantar Quality-of-Life Instrument (ppQLI) Score at Weeks 16, 24 and 48 |
Change from baseline in ppQLI score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. ppQLI assesses relevant dimensions affected by palmoplantar psoriasis (pain/discomfort, functionality, and social/activity limitations) to assess quality of life. |
Baseline and Weeks 16, 24 and 48 |
|
| Secondary |
Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16, 24 and 48 |
Change from baseline in DLQI score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. DLQI a 10-item questionnaire that can be used to assess overall quality-of-life. |
Baseline and Weeks 16, 24 and 48 |
|
| Secondary |
Change from Baseline in European Quality of Life, 5-Dimension, 5-Level (EQ-5D-5L) Score at Weeks 16, 24 and 48 |
Change from baseline in EQ-5D- 5L score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. EQ-5D-5L is a standardized instrument to measure health-related quality of life. |
Baseline and Weeks 16, 24 and 48 |
|
| Secondary |
Change from Baseline in Palmoplantar Investigator Global Assessment (ppIGA) Score at Weeks 16, 24 and 48 |
Change from baseline in ppIGA score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups to assess psoriasis overall lesions. |
Baseline and Weeks 16, 24 and 48 |
|
| Secondary |
Change from Baseline in Fingernail-Physician Global Assessment (f-PGA) Score at Weeks 16, 24 and 48 |
Change from baseline in f-PGA score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups to assess fingernails separately for nail bed and nail matrix for signs of disease. |
Baseline and Weeks 16, 24 and 48 |
|
| Secondary |
Percentage of Participants who Achieve ppPASI75 response at Weeks 24 and 48 |
Percentage of participants who achieve ppPASI75 response, defined as improvement >=75% in the ppPASI score at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles. |
Weeks 24 and 48 |
|
| Secondary |
Percentage of Participants who Achieve ppPASI90 response at Weeks 24 and 48 |
Percentage of participants who achieve ppPASI90 response (participants who achieve >=90 % improvement in the ppPASI score) at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of the affection of the palms and/or soles. |
Weeks 24 and 48 |
|
| Secondary |
Percentage of Participants who Achieve ppPASI100 response at Weeks 24 and 48 |
Percentage of participants who achieve ppPASI100 response (participants who achieve >=100 % improvement in the ppPASI score) at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of the affection of the palms and/or soles. |
Weeks 24 and 48 |
|
| Secondary |
Change from Baseline in Work Productivity and Activity Impairment: Psoriasis (WPAI: PSO) Score at Weeks 16, 24 and 48 |
Change from baseline in WPAI: PSO score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. WPAI-PSO is a questionnaire which includes 6 questions to measure work productivity and activity impairment related to skin psoriasis. |
Baseline and Weeks 16, 24 and 48 |
|
| Secondary |
Change from Baseline in Numerical Rating Scale: Pain (NRS:P) Score at Weeks 16, 24 and 48 |
Change from baseline in NRS:P score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. NRS:P is a self-administered scale that assess pain intensity in participants. |
Baseline and Weeks 16, 24 and 48 |
|
| Secondary |
Number of Participants with Adverse Event (AEs) as a Measure of Safety and Tolerability |
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
Up to 56 weeks |
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