A Phase 3 interventional study of Guselkumab and Placebo in Palmoplantar Pustulosis, sponsored by Janssen Pharmaceutical K.K.. Completed at 32 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Janssen Pharmaceutical K.K. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.
This is a phase 3, randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), multicenter (when more than one hospital works on a medical research study) placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) study in participants with palmoplantar pustulosis. The study will consist of 3 phases: screening phase (up to 6 weeks), treatment period (week 0 - week 60) and observational period (up to week 84). Participants will be assigned to 1 of 3 treatment groups (200 milligram [mg] guselkumab, 100 mg guselkumab or placebo group) using a stratified block randomization method in a 1:1:1 ratio at Week 0 and Group III (placebo) participants will be allocated in a 1:1 ratio to 1 of 2 treatment groups at Week 16. Participants will primarily be assessed for change from baseline in Palmo-Plantar Pustular Area and Severity Index (PPPASI) total score at Week 16. Safety will be monitored throughout the study.
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Exclusion Criteria:
Participants will receive guselkumab 200 milligram (mg) at Week 0, 4, 12 and every 8 weeks thereafter through Week 60, and two syringes of placebo at Week 16 to maintain the blind.
Drug: Guselkumab · Drug: Placebo
Participants will receive a syringe of guselkumab 100 mg and a syringe of placebo for guselkumab at Week 0, 4, 12 and every 8 weeks thereafter through Week 60, two syringes of placebo at Week 16 to maintain the blind.
Drug: Guselkumab · Drug: Placebo
Participants will receive two syringes of placebo at Week 0, 4 and 12. At Week 16, placebo participants will be randomized in a 1:1 ratio to guselkumab mg arm (Group 3a) or 100 mg arm (Group 3b). Group 3a participants will receive guselkumab 200 mg at Week 16, 20 and every 8 weeks thereafter through Week 60. Group 3b participants will receive guselkumab 100 mg and a syringe of placebo at Week 16, 20 and every 8 weeks thereafter through Week 60.
Drug: Guselkumab · Drug: Placebo
Participants will receive two or one syringe of guselkumab 100 mg subcutaneously at Week 0, 4, 12 and every 8 weeks thereafter through Week 60 in group 1 or 2. Group 3a or 3b participants will receive two or one syringe of guselkumab 100 mg at Week 16, 20 and every 8 weeks thereafter through Week 60.
Also known as: CNTO 1959
Participants in group 1 will receive placebo at Week 16. Participants in group 2 will receive placebo at Week 0, 4, 12, 16, 20 and every 8 weeks thereafter through Week 60. Participants in group 3 will receive placebo at Week 0, 4, 12, then at Week 16, 20 and every 8 weeks thereafter through Week 60 for group 3b.
Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16
PPPASI assesses severity of palmoplantar pustulosis (PPP) lesions and response to therapy. In PPPASI, palms, soles are divided into 4 regions: right palm(RP), left palm(LP), right sole(RS), left sole(LS), that account for 20 percent (%), 20%,30%,30%, respectively, of total surface area(TSA) of palms, soles. Each area is assessed separately for erythema(E), pustules/vesicles (P), desquamation/scales (D), each rated on a scale (0-4). PPPASI produces score range of 0-72 using formula, PPPASI=(E+P+D)Area\*0.2(RP)+(E+P+D)Area\*0.2 (LP)+(E+P+D)Area\*0.3(RS)+(E+P+D)Area\*0.3(LS). Higher a score more the severe disease. Participants who discontinue study agent as they met treatment failure(TF) criterion(lack of efficacy/AE of worsening of PPP/who started a protocol-prohibited medication/therapy that could improve PPP), their baseline value carried forward to post baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline and Week 16
Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline and Week 16
Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 16
Change From Baseline in PPPASI Total Score
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, which account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Change From Baseline in PPSI Total Score
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Percentage of Participants Who Achieved a PPPASI-50 Response
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Percentage of Participants Who Achieved a PPPASI-75 Response
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-75 response represents participants who achieved at least a 75% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Percentage of Participants Who Achieved a PPPASI-90 Response
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-90 response represents participants who achieved at least a 90% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Percentage of Participants Who Achieved a PPPASI-100 Response
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-100 response represents participants who achieved at least a 100% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Percentage of Participants Who Achieved a PPSI-50 Response
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Percentage of Participants Who Achieved a PPSI-75 Response
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Percentage of Participants Who Achieved a PPSI-90 Response
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. PPSI 90 response represents participants who achieved at least a 90% improvement from baseline in the PPSI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Percentage of Participants Who Achieved a PPSI-100 Response
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 72 and Week 84
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
The PGA documents the Physician's Global Assessment of the PPP overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) and had at least a 2-grade improvement from baseline were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a participant's QOL. It is a 10-item participant-reported outcome questionnaire that, in addition to evaluating overall QOL, can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. Higher score indicates more severe disease. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 16, 32, 52, 72 and Week 84
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score
SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 16, 32, 52, 72 and Week 84
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score
SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 16, 32, 52, 72 and Week 84
Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score
EQ-5D is designed for self-completion by participants and consists of EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and unable. The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion their baseline value carried forward to the post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Time frame: Baseline, Week 16, 32, 52, 72 and Week 84
| Milestone | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Started | 53 | 0 | 0 | 54 | 52 |
| Completed | 51 | 0 | 0 | 53 | 50 |
| Not completed | 2 | 0 | 0 | 1 | 2 |
| Withdrew: Adverse event | 2 | 0 | 0 | 1 | 2 |
| Milestone | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Started | 0 | 25 | 26 | 53 | 50 |
| Completed | 0 | 21 | 24 | 45 | 44 |
| Not completed | 0 | 4 | 2 | 8 | 6 |
| Withdrew: Adverse event | 0 | 1 | 1 | 5 | 4 |
| Withdrew: Lack of efficacy | 0 | 2 | 0 | 2 | 0 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Other | 0 | 1 | 1 | 0 | 1 |
| Milestone | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Started | 0 | 21 | 24 | 45 | 44 |
| Completed | 0 | 21 | 24 | 45 | 43 |
| Not completed | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 1 |
PPPASI assesses severity of palmoplantar pustulosis (PPP) lesions and response to therapy. In PPPASI, palms, soles are divided into 4 regions: right palm(RP), left palm(LP), right sole(RS), left sole(LS), that account for 20 percent (%), 20%,30%,30%, respectively, of total surface area(TSA) of palms, soles. Each area is assessed separately for erythema(E), pustules/vesicles (P), desquamation/scales (D), each rated on a scale (0-4). PPPASI produces score range of 0-72 using formula, PPPASI=(E+P+D)Area\*0.2(RP)+(E+P+D)Area\*0.2 (LP)+(E+P+D)Area\*0.3(RS)+(E+P+D)Area\*0.3(LS). Higher a score more the severe disease. Participants who discontinue study agent as they met treatment failure(TF) criterion(lack of efficacy/AE of worsening of PPP/who started a protocol-prohibited medication/therapy that could improve PPP), their baseline value carried forward to post baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Units on a scale | Placebo | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|
| Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 | -7.79 ± 10.596 | -15.08 ± 11.252 | -11.07 ± 7.779 |
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Units on a scale | Placebo | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|
| Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16 | -2.0 ± 2.41 | -3.9 ± 2.94 | -3.0 ± 2.57 |
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|
| Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16 | 34.0 | 57.4 | 36.5 |
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, which account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Units on a scale | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Change at week 2 | -3.58 ± 5.303 | — | — | -2.27 ± 6.832 | -3.02 ± 5.829 |
| Change at week 4 | -4.39 ± 6.805 | — | — | -6.43 ± 7.907 | -5.28 ± 5.692 |
| Change at week 8 | -6.31 ± 7.986 | — | — | -10.60 ± 8.358 | -7.94 ± 7.305 |
| Change at week 12 | -7.60 ± 9.197 | — | — | -12.80 ± 9.706 | -9.35 ± 8.121 |
| Change at week 20 | — | -12.33 ± 9.672 | -8.66 ± 11.032 | -16.33 ± 11.350 | -13.76 ± 8.278 |
| Change at week 24 | — | -14.45 ± 9.878 | -10.90 ± 10.759 | -17.86 ± 11.219 | -15.38 ± 8.864 |
| Change at week 28 | — | -15.44 ± 10.597 | -13.90 ± 11.383 | -18.32 ± 11.425 | -16.86 ± 9.443 |
| Change at week 32 | — | -16.92 ± 10.615 | -15.63 ± 10.789 | -18.52 ± 11.544 | -17.64 ± 9.792 |
| Change at week 36 | — | -18.15 ± 11.372 | -17.19 ± 11.199 | -18.87 ± 11.909 | -17.72 ± 10.083 |
| Change at week 40 | — | -19.06 ± 11.683 | -18.63 ± 10.812 | -18.85 ± 12.356 | -18.54 ± 9.887 |
| Change at week 44 | — | -18.92 ± 12.099 | -18.77 ± 11.119 | -18.91 ± 12.338 | -18.61 ± 10.093 |
| Change at week 48 | — | -19.54 ± 12.572 | -19.18 ± 10.547 | -19.72 ± 12.506 | -18.99 ± 9.686 |
| Change at week 52 | — | -20.04 ± 12.362 | -18.88 ± 11.635 | -19.95 ± 12.567 | -19.63 ± 9.776 |
| Change at week 60 | — | -20.18 ± 11.880 | -19.62 ± 11.566 | -20.17 ± 12.829 | -20.37 ± 10.098 |
| Change at week 72 | — | -22.09 ± 11.958 | -21.08 ± 11.855 | -22.13 ± 10.400 | -22.05 ± 9.136 |
| Change at week 84 | — | -22.60 ± 11.781 | -21.19 ± 13.619 | -21.32 ± 10.458 | -22.56 ± 9.352 |
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Units on a scale | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Change at week 2 | -0.5 ± 1.14 | — | — | -0.5 ± 1.68 | -0.6 ± 1.35 |
| Change at week 4 | -0.7 ± 1.26 | — | — | -1.5 ± 2.14 | -1.3 ± 1.94 |
| Change at week 8 | -1.2 ± 1.70 | — | — | -2.6 ± 2.48 | -2.0 ± 2.17 |
| Change at week 12 | -1.7 ± 2.20 | — | — | -3.3 ± 2.53 | -2.5 ± 2.58 |
| Change at week 20 | — | -3.1 ± 2.55 | -2.6 ± 2.76 | -4.0 ± 3.09 | -3.8 ± 2.68 |
| Change at week 24 | — | -3.7 ± 2.35 | -3.0 ± 3.15 | -4.5 ± 2.88 | -4.6 ± 2.71 |
| Change at week 28 | — | -3.8 ± 2.69 | -3.9 ± 3.22 | -4.6 ± 2.89 | -5.2 ± 2.79 |
| Change at week 32 | — | -3.9 ± 2.68 | -4.5 ± 3.28 | -4.7 ± 3.07 | -5.6 ± 3.11 |
| Change at week 36 | — | -4.8 ± 3.14 | -4.7 ± 3.39 | -4.9 ± 2.89 | -5.8 ± 3.18 |
| Change at week 40 | — | -5.0 ± 3.35 | -5.3 ± 3.12 | -5.1 ± 3.10 | -5.9 ± 3.01 |
| Change at week 44 | — | -5.0 ± 3.55 | -5.5 ± 2.89 | -5.2 ± 3.30 | -5.9 ± 3.14 |
| Change at week 48 | — | -5.3 ± 3.58 | -5.5 ± 2.90 | -5.3 ± 3.20 | -6.3 ± 3.17 |
| Change at week 52 | — | -5.6 ± 3.51 | -5.6 ± 3.00 | -5.7 ± 3.12 | -6.6 ± 3.17 |
| Change at week 60 | — | -5.5 ± 3.19 | -6.0 ± 3.06 | -5.6 ± 3.18 | -6.9 ± 3.25 |
| Change at week 72 | — | -6.5 ± 2.64 | -6.6 ± 2.65 | -6.3 ± 2.59 | -7.7 ± 2.78 |
| Change at week 84 | — | -7.5 ± 2.80 | -6.6 ± 3.45 | -6.0 ± 2.89 | -8.0 ± 2.79 |
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Week 2 | 1.9 | — | — | 3.7 | 1.9 |
| Week 4 | 5.7 | — | — | 9.3 | 11.5 |
| Week 8 | 11.3 | — | — | 29.6 | 25.0 |
| Week 12 | 26.4 | — | — | 48.1 | 30.8 |
| Week 20 | — | 52.0 | 42.3 | 64.8 | 51.9 |
| Week 24 | — | 56.0 | 42.3 | 79.6 | 59.6 |
| Week 28 | — | 56.0 | 65.4 | 74.1 | 75.0 |
| Week 32 | — | 68.0 | 61.5 | 74.1 | 73.1 |
| Week 36 | — | 64.4 | 73.1 | 81.5 | 75.0 |
| Week 40 | — | 68.0 | 76.9 | 81.5 | 80.8 |
| Week 44 | — | 64.0 | 76.9 | 79.6 | 76.9 |
| Week 48 | — | 68.0 | 84.6 | 83.3 | 80.8 |
| Week 52 | — | 76.0 | 73.1 | 83.3 | 84.6 |
| Week 60 | — | 80.0 | 80.8 | 79.6 | 84.6 |
| Week 72 | — | 90.5 | 83.3 | 88.9 | 93.2 |
| Week 84 | — | 85.7 | 87.5 | 88.9 | 95.3 |
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-75 response represents participants who achieved at least a 75% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Week 2 | 0 | — | — | 1.9 | 0 |
| Week 4 | 0 | — | — | 1.9 | 1.9 |
| Week 8 | 1.9 | — | — | 5.6 | 3.8 |
| Week 12 | 0 | — | — | 13 | 11.5 |
| Week 16 | 3.8 | — | — | 20.4 | 11.5 |
| Week 20 | — | 8.0 | 3.8 | 24.1 | 13.5 |
| Week 24 | — | 8.0 | 3.8 | 27.8 | 26.9 |
| Week 28 | — | 8.0 | 23.1 | 42.6 | 36.5 |
| Week 32 | — | 24.0 | 30.0 | 48.1 | 48.1 |
| Week 36 | — | 36.0 | 38.5 | 48.1 | 55.8 |
| Week 40 | — | 44.0 | 46.2 | 44.4 | 57.7 |
| Week 44 | — | 40.0 | 50.0 | 50.0 | 57.7 |
| Week 48 | — | 48.0 | 50.0 | 51.9 | 59.6 |
| Week 52 | — | 44.0 | 46.2 | 55.6 | 59.6 |
| Week 60 | — | 40.0 | 50.0 | 63.0 | 69.2 |
| Week 72 | — | 52.4 | 66.7 | 73.3 | 72.7 |
| Week 84 | — | 61.9 | 66.7 | 68.9 | 81.4 |
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-90 response represents participants who achieved at least a 90% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Week 2 | 0 | — | — | 1.9 | 0 |
| Week 4 | 0 | — | — | 1.9 | 0 |
| Week 8 | 0 | — | — | 0 | 1.9 |
| Week 12 | 0 | — | — | 1.9 | 3.8 |
| Week 16 | 0 | — | — | 1.9 | 3.8 |
| Week 20 | — | 0 | 0 | 5.6 | 7.7 |
| Week 24 | — | 0 | 0 | 9.3 | 9.6 |
| Week 28 | — | 0 | 0 | 11.1 | 11.5 |
| Week 32 | — | 0 | 11.5 | 14.8 | 19.2 |
| Week 36 | — | 8.0 | 11.5 | 16.7 | 15.4 |
| Week 40 | — | 16.0 | 15.4 | 16.7 | 17.3 |
| Week 44 | — | 20.0 | 15.4 | 20.4 | 17.3 |
| Week 48 | — | 28.0 | 26.9 | 24.1 | 28.8 |
| Week 52 | — | 32.0 | 23.1 | 29.6 | 36.5 |
| Week 60 | — | 20.0 | 34.6 | 35.2 | 44.2 |
| Week 72 | — | 28.6 | 29.2 | 37.8 | 52.3 |
| Week 84 | — | 47.6 | 41.7 | 31.1 | 51.2 |
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-100 response represents participants who achieved at least a 100% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Week 2 | 0 | — | — | 0 | 0 |
| Week 4 | 0 | — | — | 0 | 0 |
| Week 8 | 0 | — | — | 0 | 0 |
| Week 12 | 0 | — | — | 0 | 1.9 |
| Week 16 | 0 | — | — | 0 | 1.9 |
| Week 20 | — | 0 | 0 | 0 | 0 |
| Week 24 | — | 0 | 0 | 0 | 0 |
| Week 28 | — | 0 | 0 | 0 | 3.8 |
| Week 32 | — | 0 | 0 | 0 | 1.9 |
| Week 36 | — | 0 | 0 | 0 | 1.9 |
| Week 40 | — | 0 | 0 | 0 | 1.9 |
| Week 44 | — | 4.0 | 0 | 0 | 1.9 |
| Week 48 | — | 4.0 | 0 | 1.9 | 1.9 |
| Week 52 | — | 4.0 | 3.8 | 7.4 | 1.9 |
| Week 60 | — | 4.0 | 3.8 | 9.3 | 3.8 |
| Week 72 | — | 4.8 | 0 | 8.9 | 11.4 |
| Week 84 | — | 4.8 | 0 | 2.2 | 14.0 |
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Week 2 | 0 | — | — | 1.9 | 0 |
| Week 4 | 0 | — | — | 9.3 | 5.8 |
| Week 8 | 0 | — | — | 24.1 | 3.8 |
| Week 12 | 7.5 | — | — | 27.8 | 15.4 |
| Week 16 | 11.3 | — | — | 35.2 | 19.2 |
| Week 20 | — | 24.0 | 15.4 | 38.9 | 28.8 |
| Week 24 | — | 28.0 | 26.9 | 48.1 | 42.3 |
| Week 28 | — | 40.0 | 34.6 | 50.0 | 48.1 |
| Week 32 | — | 40.0 | 46.2 | 53.7 | 57.7 |
| Week 36 | — | 48.0 | 46.2 | 48.1 | 63.5 |
| Week 40 | — | 48.0 | 53.8 | 57.4 | 63.5 |
| Week 44 | — | 48.0 | 57.7 | 50.0 | 65.4 |
| Week 48 | — | 52.0 | 50.0 | 51.9 | 69.2 |
| Week 52 | — | 52.0 | 57.7 | 61.1 | 69.2 |
| Week 60 | — | 56.0 | 65.4 | 61.1 | 75.0 |
| Week 72 | — | 61.9 | 83.3 | 71.1 | 81.8 |
| Week 84 | — | 81.0 | 79.2 | 66.7 | 83.7 |
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Week 2 | 0 | — | — | 0 | 0 |
| Week 4 | 0 | — | — | 0 | 1.9 |
| Week 8 | 0 | — | — | 0 | 1.9 |
| Week 12 | 0 | — | — | 5.6 | 5.8 |
| Week 16 | 0 | — | — | 11.1 | 1.9 |
| Week 20 | — | 4.0 | 0 | 14.8 | 9.6 |
| Week 24 | — | 0 | 0 | 16.7 | 11.5 |
| Week 28 | — | 0 | 11.5 | 11.1 | 17.3 |
| Week 32 | — | 0 | 19.2 | 16.7 | 28.8 |
| Week 36 | — | 16.0 | 19.2 | 20.4 | 28.8 |
| Week 40 | — | 28.0 | 26.9 | 22.2 | 26.9 |
| Week 44 | — | 32.0 | 23.1 | 31.5 | 30.8 |
| Week 48 | — | 32.0 | 26.9 | 33.3 | 34.6 |
| Week 52 | — | 36.0 | 23.1 | 33.3 | 42.3 |
| Week 60 | — | 20.0 | 30.8 | 37.0 | 48.1 |
| Week 72 | — | 33.3 | 37.5 | 40.0 | 56.8 |
| Week 84 | — | 57.1 | 45.8 | 33.3 | 62.8 |
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. PPSI 90 response represents participants who achieved at least a 90% improvement from baseline in the PPSI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Week 2 | 0 | — | — | 0 | 0 |
| Week 4 | 0 | — | — | 0 | 0 |
| Week 8 | 0 | — | — | 0 | 1.9 |
| Week 12 | 0 | — | — | 0 | 1.9 |
| Week 16 | 0 | — | — | 1.9 | 1.9 |
| Week 20 | — | 0 | 0 | 0 | 1.9 |
| Week 24 | — | 0 | 0 | 0 | 3.8 |
| Week 28 | — | 0 | 0 | 3.7 | 3.8 |
| Week 32 | — | 0 | 11.5 | 3.7 | 7.7 |
| Week 36 | — | 4.0 | 7.7 | 1.9 | 9.6 |
| Week 40 | — | 8.0 | 7.7 | 5.6 | 9.6 |
| Week 44 | — | 12.0 | 7.7 | 16.7 | 11.5 |
| Week 48 | — | 16.0 | 7.7 | 11.1 | 17.3 |
| Week 52 | — | 20.0 | 11.5 | 16.7 | 17.3 |
| Week 60 | — | 20.0 | 15.4 | 13.0 | 25.0 |
| Week 72 | — | 23.8 | 16.7 | 22.2 | 25.0 |
| Week 84 | — | 28.6 | 29.2 | 17.8 | 32.6 |
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Week 2 | 0 | — | — | 0 | 0 |
| Week 4 | 0 | — | — | 0 | 0 |
| Week 8 | 0 | — | — | 0 | 0 |
| Week 12 | 0 | — | — | 0 | 1.9 |
| Week 16 | 0 | — | — | 0 | 1.9 |
| Week 20 | — | 0 | 0 | 0 | 0 |
| Week 24 | — | 0 | 0 | 0 | 0 |
| Week 28 | — | 0 | 0 | 0 | 3.8 |
| Week 32 | — | 0 | 0 | 0 | 3.8 |
| Week 36 | — | 4.0 | 0 | 0 | 1.9 |
| Week 40 | — | 0 | 0 | 0 | 1.9 |
| Week 44 | — | 4.0 | 0 | 5.6 | 1.9 |
| Week 48 | — | 8.0 | 0 | 3.7 | 5.8 |
| Week 52 | — | 8.0 | 3.8 | 11.1 | 5.8 |
| Week 60 | — | 8.0 | 3.8 | 9.3 | 7.7 |
| Week 72 | — | 4.8 | 0 | 11.1 | 15.9 |
| Week 84 | — | 9.5 | 4.2 | 6.7 | 20.9 |
The PGA documents the Physician's Global Assessment of the PPP overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Week 2: Clear (0) | 0 | — | — | 0 | 0 |
| Week 2: Almost clear (1) | 0 | — | — | 0 | 0 |
| Week 2: Mild (2) | 5.7 | — | — | 1.9 | 7.7 |
| Week 2: Moderate (3) | 39.6 | — | — | 46.3 | 44.2 |
| Week 2: Severe (4) | 47.2 | — | — | 48.1 | 36.5 |
| Week 2: Very severe (5) | 7.5 | — | — | 3.7 | 11.5 |
| Week 4: Clear (0) | 0 | — | — | 0 | 0 |
| Week 4: Almost clear (1) | 0 | — | — | 0 | 0 |
| Week 4: Mild (2) | 7.5 | — | — | 5.6 | 9.6 |
| Week 4: Moderate (3) | 39.6 | — | — | 53.7 | 38.5 |
| Week 4: Severe (4) | 45.3 | — | — | 38.9 | 48.1 |
| Week 4: Very severe (5) | 7.5 | — | — | 1.9 | 3.8 |
| Week 8: Clear (0) | 0 | — | — | 0 | 0 |
| Week 8: Almost clear (1) | 0 | — | — | 0 | 1.9 |
| Week 8: Mild (2) | 15.1 | — | — | 18.5 | 11.5 |
| Week 8: Moderate (3) | 37.7 | — | — | 61.1 | 48.1 |
| Week 8: Severe (4) | 41.5 | — | — | 20.4 | 36.5 |
| Week 8: Very severe (5) | 5.7 | — | — | 0 | 1.9 |
| Week 12: Clear (0) | 0 | — | — | 0 | 1.9 |
| Week 12: Almost clear (1) | 0 | — | — | 0 | 3.8 |
| Week 12: Mild (2) | 17.0 | — | — | 31.5 | 17.3 |
| Week 12: Moderate (3) | 43.4 | — | — | 48.1 | 44.2 |
| Week 12: Severe (4) | 32.1 | — | — | 20.4 | 30.8 |
| Week 12: Very severe (5) | 7.5 | — | — | 0 | 1.9 |
| Week 16: Clear (0) | 0 | — | — | 0 | 1.9 |
| Week 16: Almost clear (1) | 5.7 | — | — | 7.4 | 0 |
| Week 16: Mild (2) | 15.1 | — | — | 38.9 | 25.0 |
| Week 16: Moderate (3) | 43.4 | — | — | 44.4 | 50.0 |
| Week 16: Severe (4) | 28.3 | — | — | 9.3 | 19.2 |
| Week 16: Very severe (5) | 7.5 | — | — | 0 | 3.8 |
| Week 20: Clear (0) | — | 0 | 0 | 0 | 0 |
| Week 20: Almost clear (1) | — | 8.0 | 3.8 | 9.3 | 7.7 |
| Week 20: Mild (2) | — | 28.0 | 23.1 | 38.9 | 25.0 |
| Week 20: Moderate (3) | — | 32.0 | 42.3 | 44.4 | 53.8 |
| Week 20: Severe (4) | — | 28.0 | 23.1 | 7.4 | 9.6 |
| Week 20: Very severe (5) | — | 4.0 | 7.7 | 0 | 3.8 |
| Week 24: Clear (0) | — | 0 | 0 | 0 | 1.9 |
| Week 24: Almost clear (1) | — | 8.0 | 3.8 | 14.8 | 13.5 |
| Week 24: Mild (2) | — | 36.0 | 42.3 | 40.7 | 42.7 |
| Week 24: Moderate (3) | — | 36.0 | 26.9 | 37.0 | 42.3 |
| Week 24: Severe (4) | — | 16.0 | 23.1 | 7.4 | 7.7 |
| Week 24: Very severe (5) | — | 4.0 | 3.8 | 0 | 1.9 |
| Week 28: Clear (0) | — | 0 | 0 | 0 | 3.8 |
| Week 28: Almost clear (1) | — | 8.0 | 3.8 | 14.8 | 13.5 |
| Week 28: Mild (2) | — | 28.0 | 46.2 | 46.3 | 40.4 |
| Week 28: Moderate (3) | — | 48.0 | 23.1 | 33.3 | 38.5 |
| Week 28: Severe (4) | — | 12.0 | 26.9 | 5.6 | 1.9 |
| Week 28: Very severe (5) | — | 4.0 | 0 | 0 | 1.9 |
| Week 32: Clear (0) | — | 0 | 0 | 0 | 1.9 |
| Week 32: Almost clear (1) | — | 8.0 | 11.5 | 16.7 | 23.1 |
| Week 32: Mild (2) | — | 32.0 | 46.2 | 46.3 | 36.5 |
| Week 32: Moderate (3) | — | 48.0 | 26.9 | 31.5 | 26.9 |
| Week 32: Severe (4) | — | 12.0 | 15.4 | 5.6 | 9.6 |
| Week 32: Very severe (5) | — | 0 | 0 | 0 | 1.9 |
| Week 36: Clear (0) | — | 0 | 0 | 0 | 1.9 |
| Week 36: Almost clear (1) | — | 12.0 | 19.2 | 22.2 | 23.1 |
| Week 36: Mild (2) | — | 36.0 | 42.3 | 44.4 | 38.5 |
| Week 36: Moderate (3) | — | 32.0 | 30.8 | 29.6 | 30.8 |
| Week 36: Severe (4) | — | 20.0 | 7.7 | 3.7 | 3.8 |
| Week 36: Very severe (5) | — | 0 | 0 | 0 | 1.9 |
| Week 40: Clear (0) | — | 0 | 0 | 0 | 1.9 |
| Week 40: Almost clear (1) | — | 20.0 | 23.1 | 24.1 | 26.9 |
| Week 40: Mild (2) | — | 28.0 | 38.5 | 37.0 | 38.5 |
| Week 40: Moderate (3) | — | 36.0 | 30.8 | 33.0 | 28.8 |
| Week 40: Severe (4) | — | 16.0 | 7.7 | 5.6 | 1.9 |
| Week 40: Very severe (5) | — | 0 | 0 | 0 | 1.9 |
| Week 44: Clear (0) | — | 4.0 | 0 | 3.7 | 1.9 |
| Week 44: Almost clear (1) | — | 24.0 | 15.4 | 24.1 | 32.7 |
| Week 44: Mild (2) | — | 24.0 | 50.0 | 40.7 | 32.7 |
| Week 44: Moderate (3) | — | 28.0 | 30.8 | 25.9 | 26.9 |
| Week 44: Severe (4) | — | 20.0 | 3.8 | 5.6 | 3.8 |
| Week 44: Very severe (5) | — | 0 | 0 | 0 | 1.9 |
| Week 48: Clear (0) | — | 4.0 | 0 | 1.9 | 3.8 |
| Week 48: Almost clear (1) | — | 32.0 | 26.9 | 29.6 | 25.0 |
| Week 48: Mild (2) | — | 8.0 | 38.5 | 35.2 | 50.0 |
| Week48: Moderate (3) | — | 40.0 | 30.8 | 27.0 | 15.4 |
| Week 48: Severe (4) | — | 16.0 | 3.8 | 5.6 | 3.8 |
| Week 48: Very severe (5) | — | 0 | 0 | 0 | 1.9 |
| Week 52: Clear (0) | — | 4.0 | 3.8 | 7.4 | 3.8 |
| Week 52: Almost clear (1) | — | 28.0 | 23.1 | 24.1 | 21.2 |
| Week 52: Mild (2) | — | 20.0 | 50.0 | 40.7 | 51.9 |
| Week 52: Moderate (3) | — | 32.0 | 19.2 | 24.1 | 21.2 |
| Week 52: Severe (4) | — | 16.0 | 3.8 | 3.7 | 0 |
| Week 52: Very severe (5) | — | 0 | 0 | 0 | 1.9 |
| Week 60: Clear (0) | — | 4.0 | 3.8 | 9.3 | 5.8 |
| Week 60: Almost clear (1) | — | 20.0 | 23.1 | 25.9 | 44.2 |
| Week 60: Mild (2) | — | 24.0 | 46.2 | 38.9 | 26.9 |
| Week 60: Moderate (3) | — | 40.0 | 26.9 | 20.4 | 21.2 |
| Week 60: Severe (4) | — | 12.0 | 0 | 5.6 | 0 |
| Week 60: Very severe (5) | — | 0 | 0 | 0 | 1.9 |
| Week 72: Clear (0) | — | 4.8 | 0 | 11.1 | 13.6 |
| Week 72: Almost clear (1) | — | 19.0 | 37.5 | 28.9 | 38.6 |
| Week 72: Mild (2) | — | 52.4 | 50.0 | 42.2 | 34.1 |
| Week 72: Moderate (3) | — | 19.0 | 12.5 | 17.8 | 13.6 |
| Week 72: Severe (4) | — | 4.8 | 0 | 0 | 0 |
| Week 72: Very severe (5) | — | 0 | 0 | 0 | 0 |
| Week 84: Clear (0) | — | 4.8 | 0 | 4.4 | 16.3 |
| Week 84: Almost clear (1) | — | 38.1 | 54.2 | 33.3 | 37.2 |
| Week 84: Mild (2) | — | 38.1 | 29.2 | 42.2 | 34.9 |
| Week 84: Moderate (3) | — | 4.8 | 12.5 | 13.3 | 9.3 |
| Week 84: Severe (4) | — | 14.3 | 0 | 6.7 | 2.3 |
| Week 84: Very severe (5) | — | 0 | 4.2 | 0 | 0 |
The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Week 2 | 0 | — | — | 0 | 0 |
| Week 4 | 0 | — | — | 0 | 0 |
| Week 8 | 0 | — | — | 0 | 1.9 |
| Week 12 | 0 | — | — | 0 | 5.8 |
| Week 16 | 5.7 | — | — | 7.4 | 1.9 |
| Week 20 | — | 8.0 | 3.8 | 9.3 | 7.7 |
| Week 24 | — | 8.0 | 3.8 | 14.8 | 15.4 |
| Week 28 | — | 8.0 | 3.8 | 14.8 | 17.3 |
| Week 32 | — | 8.0 | 11.5 | 16.7 | 25.0 |
| Week 36 | — | 12.0 | 19.2 | 22.2 | 25.0 |
| Week 40 | — | 20.0 | 23.1 | 24.1 | 28.8 |
| Week 44 | — | 28.0 | 15.4 | 27.8 | 34.6 |
| Week 48 | — | 36.0 | 26.9 | 31.5 | 28.8 |
| Week 52 | — | 32.0 | 26.9 | 31.5 | 25.0 |
| Week 60 | — | 24.0 | 26.9 | 35.2 | 50.0 |
| Week 72 | — | 23.8 | 37.5 | 40.0 | 52.3 |
| Week 84 | — | 42.9 | 54.2 | 37.8 | 53.5 |
The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) and had at least a 2-grade improvement from baseline were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Percentage of participants | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Week 2 | 0 | — | — | 0 | 0 |
| Week 4 | 0 | — | — | 0 | 0 |
| Week 8 | 0 | — | — | 0 | 1.9 |
| Week 12 | 0 | — | — | 0 | 5.8 |
| Week 16 | 5.7 | — | — | 7.4 | 1.9 |
| Week 20 | — | 8.0 | 3.8 | 9.3 | 7.7 |
| Week 24 | — | 8.0 | 3.8 | 14.8 | 15.4 |
| Week 28 | — | 8.0 | 3.8 | 14.8 | 17.3 |
| Week 32 | — | 8.0 | 11.5 | 16.7 | 25.0 |
| Week 36 | — | 12.0 | 19.2 | 22.2 | 25.0 |
| Week 40 | — | 20.0 | 23.1 | 24.1 | 28.8 |
| Week 44 | — | 28.0 | 15.4 | 27.8 | 34.6 |
| Week 48 | — | 36.0 | 26.9 | 31.5 | 28.8 |
| Week 52 | — | 32.0 | 26.9 | 31.5 | 25.0 |
| Week 60 | — | 24.0 | 26.9 | 35.2 | 50.0 |
| Week 72 | — | 23.8 | 37.5 | 40.0 | 52.3 |
| Week 84 | — | 42.9 | 54.2 | 37.8 | 53.5 |
The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a participant's QOL. It is a 10-item participant-reported outcome questionnaire that, in addition to evaluating overall QOL, can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. Higher score indicates more severe disease. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Units on a scale | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Change at week 16 | -1.8 ± 4.71 | — | — | -5.0 ± 5.59 | -3.1 ± 3.49 |
| Change at week 32 | — | -4.3 ± 5.25 | -4.2 ± 5.09 | -5.2 ± 5.90 | -4.2 ± 4.18 |
| Change at week 52 | — | -4.8 ± 5.74 | -5.2 ± 5.10 | -5.7 ± 6.05 | -4.9 ± 5.24 |
| Change at week 72 | — | -5.5 ± 5.82 | -5.8 ± 4.28 | -6.2 ± 5.78 | -5.8 ± 5.20 |
| Change at week 84 | — | -6.0 ± 5.29 | -5.6 ± 4.66 | -6.4 ± 5.59 | -6.3 ± 5.41 |
SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Units on a scale | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Change at week 16 | 1.27 ± 9.177 | — | — | 4.67 ± 13.753 | 3.34 ± 10.259 |
| Change at week 32 | — | 5.46 ± 16.226 | 7.16 ± 11.507 | 8.31 ± 15.510 | 4.82 ± 9.975 |
| Change at week 52 | — | 7.92 ± 14.580 | 8.18 ± 11.320 | 7.35 ± 17.320 | 6.47 ± 11.466 |
| Change at week 72 | — | 9.02 ± 17.049 | 7.02 ± 11.806 | 6.75 ± 15.098 | 7.55 ± 11.453 |
| Change at week 84 | — | 9.29 ± 19.175 | 9.01 ± 12.964 | 7.06 ± 15.034 | 6.75 ± 13.619 |
SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Units on a scale | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Change at week 16 | 1.20 ± 7.823 | — | — | 0.64 ± 7.880 | 0.66 ± 7.055 |
| Change at week 32 | — | 2.19 ± 10.277 | 1.10 ± 7.579 | 0.52 ± 8.124 | 0.59 ± 7.639 |
| Change at week 52 | — | 1.44 ± 9.980 | 0.39 ± 7.431 | 1.69 ± 7.866 | 0.69 ± 7.354 |
| Change at week 72 | — | 1.51 ± 10.679 | 0.02 ± 8.686 | 2.19 ± 7.112 | 0.92 ± 6.797 |
| Change at week 84 | — | 1.72 ± 8.740 | 0.78 ± 6.975 | 2.51 ± 8.428 | 2.58 ± 7.977 |
EQ-5D is designed for self-completion by participants and consists of EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and unable. The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion their baseline value carried forward to the post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
| Units on a scale | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Change at week 16 | -0.1 ± 14.33 | — | — | 8.3 ± 21.25 | 8.5 ± 15.59 |
| Change at week 32 | — | 8.0 ± 25.36 | 6.5 ± 15.75 | 10.2 ± 21.88 | 5.9 ± 15.98 |
| Change at week 52 | — | 13.0 ± 24.69 | 5.6 ± 16.28 | 13.9 ± 22.19 | 7.9 ± 15.19 |
| Change at week 72 | — | 13.0 ± 21.59 | 8.7 ± 21.08 | 12.9 ± 22.43 | 10.5 ± 17.11 |
| Change at week 84 | — | 6.7 ± 24.71 | 10.0 ± 19.55 | 10.5 ± 21.53 | 8.7 ± 18.42 |
Collected over Baseline (Week 0) up to Week 84. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/53 (0%) | 2/53 (3.8%) | 34/53 (64.2%) |
| Placebo Then Guselkumab 100 mg | 0/25 (0%) | 3/25 (12%) | 23/25 (92%) |
| Placebo Then Guselkumab 200 mg | 0/26 (0%) | 1/26 (3.8%) | 22/26 (84.6%) |
| Guselkumab 100 mg | 0/54 (0%) | 3/54 (5.6%) | 44/54 (81.5%) |
| Guselkumab 200 mg | 0/52 (0%) | 5/52 (9.6%) | 49/52 (94.2%) |
| Event | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| Gastric CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/53 | 1/25 | 0/26 | 0/54 | 0/52 |
| Abdominal DiscomfortGastrointestinal disorders | 0/53 | 1/25 | 0/26 | 0/54 | 0/52 |
| Medical Device RemovalSurgical and medical procedures | 0/53 | 1/25 | 0/26 | 0/54 | 0/52 |
| Gastric Ulcer HaemorrhageGastrointestinal disorders | 0/53 | 0/25 | 1/26 | 0/54 | 0/52 |
| Large Intestine PolypGastrointestinal disorders | 1/53 | 0/25 | 0/26 | 0/54 | 1/52 |
| Abortion InducedSurgical and medical procedures | 0/53 | 0/25 | 0/26 | 0/54 | 1/52 |
| TonsillitisInfections and infestations | 0/53 | 0/25 | 0/26 | 0/54 | 1/52 |
| Ankle FractureInjury, poisoning and procedural complications | 0/53 | 0/25 | 0/26 | 0/54 | 1/52 |
| Upper Respiratory Tract InflammationRespiratory, thoracic and mediastinal disorders | 0/53 | 0/25 | 0/26 | 0/54 | 1/52 |
| Heat StrokeInjury, poisoning and procedural complications | 1/53 | 0/25 | 0/26 | 0/54 | 0/52 |
| Event | Placebo | Placebo Then Guselkumab 100 mg | Placebo Then Guselkumab 200 mg | Guselkumab 100 mg | Guselkumab 200 mg |
|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 9/53 | 17/25 | 14/26 | 20/54 | 25/52 |
| Injection Site ErythemaGeneral disorders | 0/53 | 3/25 | 5/26 | 4/54 | 10/52 |
| EczemaSkin and subcutaneous tissue disorders | 3/53 | 3/25 | 2/26 | 6/54 | 8/52 |
| UrticariaSkin and subcutaneous tissue disorders | 1/53 | 2/25 | 1/26 | 2/54 | 7/52 |
| HyperlipidaemiaMetabolism and nutrition disorders | 0/53 | 3/25 | 0/26 | 2/54 | 1/52 |
| Dental CariesGastrointestinal disorders | 2/53 | 2/25 | 3/26 | 4/54 | 4/52 |
| Injection Site PruritusGeneral disorders | 1/53 | 2/25 | 3/26 | 1/54 | 5/52 |
| Injection Site SwellingGeneral disorders | 0/53 | 0/25 | 3/26 | 2/54 | 3/52 |
| Oral HerpesInfections and infestations | 2/53 | 0/25 | 3/26 | 0/54 | 3/52 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/53 | 0/25 | 1/26 | 4/54 | 5/52 |
| Age, Continuous(years) | Placebo | Guselkumab 100 mg | Guselkumab 200 mg | Total |
|---|---|---|---|---|
| Mean | 53 ± 8.14 | 53.9 ± 10.88 | 52.9 ± 13.39 | 53.3 ± 10.94 |
| Sex: Female, Male(Participants) | Placebo | Guselkumab 100 mg | Guselkumab 200 mg | Total |
|---|---|---|---|---|
| Female | 44 | 46 | 36 | 126 |
| Male | 9 | 8 | 16 | 33 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Guselkumab 100 mg | Guselkumab 200 mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 53 | 54 | 52 | 159 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Guselkumab 100 mg | Guselkumab 200 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 53 | 54 | 52 | 159 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo | Guselkumab 100 mg | Guselkumab 200 mg | Total |
|---|---|---|---|---|
| JAPAN | 53 | 54 | 52 | 159 |
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