Back to resultsAn Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
Primary Purpose
Palmoplantar Pustulosis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Guselkumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Palmoplantar Pustulosis focused on measuring Guselkumab, CNTO 1959, Placebo, Palmoplantar Pustulosis
Eligibility Criteria
Inclusion Criteria:
- Has a diagnosis of palmoplantar pustulosis (with or without pustulotic arthro-osteitis, concurrent extra-palmoplantar lesions) for at least 24 weeks before screening
- Has a >= 12 PPPASI total score at screening and at baseline
- Has a moderate or more severe pustules/vesicle on the palms or soles (>= 2 PPPASI severity score) at screening and baseline
- Has inadequate response to the treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or the phototherapy and/or systemic etretinate prior to or at screening. Inadequate response is defined as a case judged by the investigator
- Before the first administration of study drug, a woman must be either: Not of childbearing potential: premenarchal; postmenopausal or Of childbearing potential and practicing a highly effective method of birth control
Exclusion Criteria:
- Has a diagnosis of plaque-type psoriasis
- Has obvious improvement during screening (>= 5 PPPASI total score improvement during the screening)
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 12 weeks or a cardiac hospitalization within the last 12 weeks before screening
- Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks before screening or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 12 weeks before screening)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02641730
First Posted
December 14, 2015
Last Updated
July 29, 2019
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT02641730
Brief Title
An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Palmoplantar Pustulosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2015 (Actual)
Primary Completion Date
March 28, 2017 (Actual)
Study Completion Date
July 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmoplantar Pustulosis
Keywords
Guselkumab, CNTO 1959, Placebo, Palmoplantar Pustulosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
CNTO 1959
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16
Description
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
Title
Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16
Description
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
Title
Change From Baseline in PPPASI Total Score
Description
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
Title
Change From Baseline in PPSI Total Score
Description
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
Title
Percentage of Participants Who Achieved a PPPASI-50 Response
Description
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
Title
Percentage of Participants Who Achieved a PPPASI-75 Response
Description
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
Title
Percentage of Participants Who Achieved a PPPASI-90 Response
Description
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
Title
Percentage of Participants Who Achieved a PPPASI-100 Response
Description
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
Title
Percentage of Participants Who Achieved a PPSI-50 Response
Description
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
Title
Percentage of Participants Who Achieved a PPSI-75 Response
Description
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
Title
Percentage of Participants Who Achieved a PPSI-90 Response
Description
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
Title
Percentage of Participants Who Achieved a PPSI-100 Response
Description
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
Title
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Description
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
Title
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Description
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
Title
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Description
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
Title
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
Description
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
Title
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score
Description
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
Title
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score
Description
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
Title
Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has a diagnosis of palmoplantar pustulosis (with or without pustulotic arthro-osteitis, concurrent extra-palmoplantar lesions) for at least 24 weeks before screening
Has a >= 12 PPPASI total score at screening and at baseline
Has a moderate or more severe pustules/vesicle on the palms or soles (>= 2 PPPASI severity score) at screening and baseline
Has inadequate response to the treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or the phototherapy and/or systemic etretinate prior to or at screening. Inadequate response is defined as a case judged by the investigator
Before the first administration of study drug, a woman must be either: Not of childbearing potential: premenarchal; postmenopausal or Of childbearing potential and practicing a highly effective method of birth control
Exclusion Criteria:
Has a diagnosis of plaque-type psoriasis
Has obvious improvement during screening (>= 5 PPPASI total score improvement during the screening)
Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 12 weeks or a cardiac hospitalization within the last 12 weeks before screening
Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks before screening or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 12 weeks before screening)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K. Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Asahikawa
Country
Japan
City
Fukuoka
Country
Japan
City
Fukushima
Country
Japan
City
Hachioji
Country
Japan
City
Hokkaido
Country
Japan
City
Ichikawa
Country
Japan
City
Ichinomiya-City
Country
Japan
City
Kahoku-District
Country
Japan
City
Kanazawa
Country
Japan
City
Kobe
Country
Japan
City
Kochi
Country
Japan
City
Kofu
Country
Japan
City
Kumamoto-City
Country
Japan
City
Kyoto
Country
Japan
City
Matsumoto
Country
Japan
City
Morioka
Country
Japan
City
Nagasaki
Country
Japan
City
Nagoya
Country
Japan
City
Osaka-Sayama
Country
Japan
City
Osaka
Country
Japan
City
Sagamihara
Country
Japan
City
Saku
Country
Japan
City
Shimotsuke
Country
Japan
City
Takamatsu
Country
Japan
City
Tokushima
Country
Japan
City
Tokyo
Country
Japan
City
Toon
Country
Japan
City
Toyoake
Country
Japan
City
Tsukuba
Country
Japan
City
Tsu
Country
Japan
City
Yokohama
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31268476
Citation
Terui T, Kobayashi S, Okubo Y, Murakami M, Zheng R, Morishima H, Goto R, Kimura T. Efficacy and Safety of Guselkumab in Japanese Patients With Palmoplantar Pustulosis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2019 Oct 1;155(10):1153-1161. doi: 10.1001/jamadermatol.2019.1394.
Results Reference
derived
Learn more about this trial
An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
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