Trial · NCT02641730
An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
NCT02641730, Phase 3, Completed, Janssen Pharmaceutical K.K.; results first posted 2019-02-21
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ConductScience Library. An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis. Trials, record NCT02641730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02641730
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
- NCT number
- NCT02641730
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 159 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Palmoplantar Pustulosis
- Interventions
- Guselkumab, Placebo
- First posted
- 2015-12-29
- Last updated
- 2025-02-04
- Results first posted
- 2019-02-21
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 | Baseline and 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 | Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16 | Baseline and 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. |
| Secondary | Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16 | 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. |
| Secondary | Change From Baseline in PPPASI Total Score | Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | 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. |
| Secondary | Change From Baseline in PPSI Total Score | Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | 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. |
| Secondary | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | 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. |
| Secondary | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | 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. |
| Secondary | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | 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. |
| Secondary | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | 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. |
| Secondary | Percentage of Participants Who Achieved a PPSI-50 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 | Baseline and Week 16 | Randomized analysis set: all randomized participants at Week 0, whether they received study treatment or not and had any post-baseline efficacy assessment. Missing values were imputed based on TF criterion, last observation carried forward (LOCF) method till Week 60;no imputation performed for missing data after Week 60 (in observational period). | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16 | Baseline and Week 16 | Population included Randomized analysis set. The missing values were imputed based on Treatment Failure (TF) criterion and last scheduled observation carried forward (LOCF) method until Week 60; no imputation performed for missing data after Week 60 (in observational period). | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16 | Week 16 | Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in PPPASI Total Score | Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in PPSI Total Score | Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Achieved a PPPASI-50 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a PPPASI-75 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a PPPASI-90 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a PPPASI-100 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a PPSI-50 Response | Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84 | Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point. | Percentage of participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group1,210
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 | Placebo | -7.79 | Standard Deviation 10.596 | Units on a scale | |
| Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 | Guselkumab 100 mg | -15.08 | Standard Deviation 11.252 | Units on a scale | |
| Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 | Guselkumab 200 mg | -11.07 | Standard Deviation 7.779 | Units on a scale | |
| Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16 | Placebo | -2.0 | Standard Deviation 2.41 | Units on a scale | |
| Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16 | Guselkumab 100 mg | -3.9 | Standard Deviation 2.94 | Units on a scale | |
| Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16 | Guselkumab 200 mg | -3.0 | Standard Deviation 2.57 | Units on a scale | |
| Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16 | Placebo | 34.0 | Percentage of participants | ||
| Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16 | Guselkumab 100 mg | 57.4 | Percentage of participants | ||
| Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16 | Guselkumab 200 mg | 36.5 | Percentage of participants | ||
| Change From Baseline in PPPASI Total Score | Placebo | Change at week 2 | -3.58 | Standard Deviation 5.303 | Units on a scale |
1 to 10 of 1,210Source ClinicalTrials.gov
See all 1,210 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo Controlled Period (Week 0 - 16) | STARTED | Placebo | 53 | |
| Placebo Controlled Period (Week 0 - 16) | STARTED | Placebo Then Guselkumab 100 mg | 0 | |
| Placebo Controlled Period (Week 0 - 16) | STARTED | Placebo Then Guselkumab 200 mg | 0 | |
| Placebo Controlled Period (Week 0 - 16) | STARTED | Guselkumab 100 mg | 54 | |
| Placebo Controlled Period (Week 0 - 16) | STARTED | Guselkumab 200 mg | 52 | |
| Placebo Controlled Period (Week 0 - 16) | COMPLETED | Placebo | 51 | |
| Placebo Controlled Period (Week 0 - 16) | COMPLETED | Placebo Then Guselkumab 100 mg | 0 | |
| Placebo Controlled Period (Week 0 - 16) | COMPLETED | Placebo Then Guselkumab 200 mg | 0 | |
| Placebo Controlled Period (Week 0 - 16) | COMPLETED | Guselkumab 100 mg | 53 | |
| Placebo Controlled Period (Week 0 - 16) | COMPLETED | Guselkumab 200 mg | 50 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events590
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 53 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Then Guselkumab 100 mg | 0 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Then Guselkumab 200 mg | 0 | 26 | |
| other | Anaemia | Blood and lymphatic system disorders | Guselkumab 100 mg | 2 | 54 | |
| other | Anaemia | Blood and lymphatic system disorders | Guselkumab 200 mg | 0 | 52 | |
| other | Ventricular Extrasystoles | Cardiac disorders | Placebo | 0 | 53 | |
| other | Ventricular Extrasystoles | Cardiac disorders | Placebo Then Guselkumab 100 mg | 0 | 25 | |
| other | Ventricular Extrasystoles | Cardiac disorders | Placebo Then Guselkumab 200 mg | 1 | 26 | |
| other | Ventricular Extrasystoles | Cardiac disorders | Guselkumab 100 mg | 0 | 54 | |
| other | Ventricular Extrasystoles | Cardiac disorders | Guselkumab 200 mg | 0 | 52 |
1 to 10 of 590Source ClinicalTrials.gov
See all 590 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 53 |
| Total, all-cause mortality | Placebo Then Guselkumab 100 mg | 0 | 25 |
| Total, all-cause mortality | Placebo Then Guselkumab 200 mg | 0 | 26 |
| Total, all-cause mortality | Guselkumab 100 mg | 0 | 54 |
| Total, all-cause mortality | Guselkumab 200 mg | 0 | 52 |
| Total, other adverse events | Placebo | 34 | 53 |
| Total, other adverse events | Placebo Then Guselkumab 100 mg | 23 | 25 |
| Total, other adverse events | Placebo Then Guselkumab 200 mg | 22 | 26 |
| Total, other adverse events | Guselkumab 100 mg | 44 | 54 |
| Total, other adverse events | Guselkumab 200 mg | 49 | 52 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31268476 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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