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Trial record 2 of 15 for:    "Pustulosis Palmaris Et Plantaris"

An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02641730
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Palmoplantar Pustulosis
Interventions Drug: Guselkumab
Drug: Placebo
Enrollment 159
Recruitment Details  
Pre-assignment Details Results are reported through Week 52. Complete data through Week 84 will be reported within 1 year of end of study trial date when final data based on study completion date will be available.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg. Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60. Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60. Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Period Title: Placebo Controlled Period (Week 0 - 16)
Started 53 0 0 54 52
Completed 51 0 0 53 50
Not Completed 2 0 0 1 2
Reason Not Completed
Adverse Event             2             0             0             1             2
Period Title: After Controlled Period (Week 16 – 52)
Started 0 25 26 53 50
Completed 0 22 24 45 44
Not Completed 0 3 2 8 6
Reason Not Completed
Adverse Event             0             1             1             5             4
Lack of Efficacy             0             2             0             2             0
Pregnancy             0             0             0             1             1
Other             0             0             1             0             1
Arm/Group Title Placebo Guselkumab 100 mg Guselkumab 200 mg Total
Hide Arm/Group Description Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg. Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. Total of all reporting groups
Overall Number of Baseline Participants 53 54 52 159
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 54 participants 52 participants 159 participants
53  (8.14) 53.9  (10.88) 52.9  (13.39) 53.3  (10.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 54 participants 52 participants 159 participants
Female
44
  83.0%
46
  85.2%
36
  69.2%
126
  79.2%
Male
9
  17.0%
8
  14.8%
16
  30.8%
33
  20.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 54 participants 52 participants 159 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
53
 100.0%
54
 100.0%
52
 100.0%
159
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 54 participants 52 participants 159 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
53
 100.0%
54
 100.0%
52
 100.0%
159
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
JAPAN Number Analyzed 53 participants 54 participants 52 participants 159 participants
53
 100.0%
54
 100.0%
52
 100.0%
159
 100.0%
1.Primary Outcome
Title Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16
Hide Description PPPASI assesses severity of palmoplantar pustulosis (PPP) lesions and response to therapy. In PPPASI system, 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 a score range from 0-72 by 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 score indicates more severe disease. Participants who discontinue study agent as they met a 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.
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on Treatment Failure (TF) criterion and last scheduled observation carried forward (LOCF) method.
Arm/Group Title Placebo Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 54 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-7.79  (10.596) -15.08  (11.252) -11.07  (7.779)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed-Model for Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.69
Confidence Interval (2-Sided) 95%
-11.000 to -4.383
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.674
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Mixed-Model for Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.11
Confidence Interval (2-Sided) 95%
-7.468 to -0.748
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.700
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Palmoplanter Severity Index (PPSI) Total Score at Week 16
Hide Description PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. 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.
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 54 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.0  (2.41) -3.9  (2.94) -3.0  (2.57)
3.Secondary Outcome
Title Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16
Hide 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 nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
34.0 57.4 36.5
4.Secondary Outcome
Title Change From Baseline in PPPASI Total Score
Hide 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.
Time Frame Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
-3.58  (5.303) -2.27  (6.832) -3.02  (5.829)
Change at week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
-4.39  (6.805) -6.43  (7.907) -5.28  (5.692)
Change at week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
-6.31  (7.986) -10.60  (8.358) -7.94  (7.305)
Change at week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
-7.60  (9.197) -12.80  (9.706) -9.35  (8.121)
Change at week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-12.33  (9.672) -8.66  (11.032) -16.33  (11.350) -13.76  (8.278)
Change at week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-14.45  (9.878) -10.90  (10.759) -17.86  (11.219) -15.38  (8.864)
Change at week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-15.44  (10.597) -13.90  (11.383) -18.32  (11.425) -16.86  (9.443)
Change at week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-16.92  (10.615) -15.63  (10.789) -18.52  (11.544) -17.64  (9.792)
Change at week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-18.15  (11.372) -17.19  (11.199) -18.87  (11.909) -17.72  (10.083)
Change at week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-19.06  (11.683) -18.63  (10.812) -18.85  (12.356) -18.54  (9.887)
Change at week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-18.92  (12.099) -18.77  (11.119) -18.91  (12.338) -18.61  (10.093)
Change at week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-19.54  (12.572) -19.18  (10.547) -19.72  (12.506) -18.99  (9.686)
Change at week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-20.04  (12.362) -18.88  (11.635) -19.95  (12.567) -19.63  (9.776)
5.Secondary Outcome
Title Change From Baseline in PPSI Total Score
Hide Description The PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening. The identified site was to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for the most severe skin lesion rated on a scale of 0 to 4. 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.
Time Frame Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
-0.5  (1.14) -0.5  (1.68) -0.6  (1.35)
Change at week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
-0.7  (1.26) -1.5  (2.14) -1.3  (1.94)
Change at week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
-1.2  (1.70) -2.6  (2.48) -2.0  (2.17)
Change at week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
-1.7  (2.20) -3.3  (2.53) -2.5  (2.58)
Change at week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-3.1  (2.55) -2.6  (2.76) -4.0  (3.09) -3.8  (2.68)
Change at week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-3.7  (2.35) -3.0  (3.15) -4.5  (2.88) -4.6  (2.71)
Change at week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-3.8  (2.69) -3.9  (3.22) -4.6  (2.89) -5.2  (2.79)
Change at week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-3.9  (2.68) -4.5  (3.28) -4.7  (3.07) -5.6  (3.11)
Change at week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-4.8  (3.14) -4.7  (3.39) -4.9  (2.89) -5.8  (3.18)
Change at week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-5.0  (3.35) -5.3  (3.12) -5.1  (3.10) -5.9  (3.01)
Change at week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-5.0  (3.55) -5.5  (2.89) -5.2  (3.30) -5.9  (3.14)
Change at week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-5.3  (3.58) -5.5  (2.90) -5.3  (3.20) -6.3  (3.17)
Change at week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-5.6  (3.51) -5.6  (3.00) -5.7  (3.12) -6.6  (3.17)
6.Secondary Outcome
Title Percentage of Participants Who Achieved a PPPASI-50 Response
Hide 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 nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
1.9 3.7 1.9
Week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
5.7 9.3 11.5
Week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
11.3 29.6 25.0
Week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
26.4 48.1 30.8
Week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
52.0 42.3 64.8 51.9
Week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
56.0 42.3 79.6 59.6
Week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
56.0 65.4 74.1 75.0
Week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
68.0 61.5 74.1 73.1
Week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
64.4 73.1 81.5 75.0
Week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
68.0 76.9 81.5 80.8
Week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
64.0 76.9 79.6 76.9
Week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
68.0 84.6 83.3 80.8
Week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
76.0 73.1 83.3 84.6
7.Secondary Outcome
Title Percentage of Participants Who Achieved a PPPASI-75 Response
Hide 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.
Time Frame Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 1.9 0
Week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 1.9 1.9
Week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
1.9 5.6 3.8
Week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 13 11.5
Week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
3.8 20.4 11.5
Week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 24.1 13.5
Week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 27.8 26.9
Week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 23.1 42.6 36.5
Week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
24.0 30.0 48.1 48.1
Week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
36.0 38.5 48.1 55.8
Week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
44.0 46.2 44.4 57.7
Week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
40.0 50.0 50.0 57.7
Week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
48.0 50.0 51.9 59.6
Week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
44.0 46.2 55.6 59.6
8.Secondary Outcome
Title Percentage of Participants Who Achieved a PPPASI-90 Response
Hide 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 nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 1.9 0
Week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 1.9 0
Week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 1.9 3.8
Week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 1.9 3.8
Week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 5.6 7.7
Week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 9.3 9.6
Week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 11.1 11.5
Week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 11.5 14.8 19.2
Week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 11.5 16.7 15.4
Week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
16.0 15.4 16.7 17.3
Week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
20.0 15.4 20.4 17.3
Week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
28.0 26.9 24.1 28.8
Week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
32.0 23.1 29.6 36.5
9.Secondary Outcome
Title Percentage of Participants Who Achieved a PPPASI-100 Response
Hide 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 nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 0
Week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 0
Week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 3.8
Week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 0 0 1.9
Week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 0 1.9 1.9
Week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 3.8 7.4 1.9
10.Secondary Outcome
Title Percentage of Participants Who Achieved a PPSI-50 Response
Hide Description PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. 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 50 response represents participants who achieved at least a 50% 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 nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 1.9 0
Week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 9.3 5.8
Week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 24.1 3.8
Week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
7.5 27.8 15.4
Week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
11.3 35.2 19.2
Week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
24.0 15.4 38.9 28.8
Week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
28.0 26.9 48.1 42.3
Week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
40.0 34.6 50.0 48.1
Week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
40.0 46.2 53.7 57.7
Week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
48.0 46.2 48.1 63.5
Week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
48.0 53.8 57.4 63.5
Week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
48.0 57.7 50.0 65.4
Week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
52.0 50.0 51.9 69.2
Week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
52.0 57.7 61.1 69.2
11.Secondary Outcome
Title Percentage of Participants Who Achieved a PPSI-75 Response
Hide Description PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. 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 75 response represents participants who achieved at least a 75% 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 nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 5.6 5.8
Week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 11.1 1.9
Week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 0 14.8 9.6
Week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 16.7 11.5
Week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 11.5 11.1 17.3
Week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 19.2 16.7 28.8
Week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
16.0 19.2 20.4 28.8
Week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
28.0 26.9 22.2 26.9
Week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
32.0 23.1 31.5 30.8
Week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
32.0 26.9 33.3 34.6
Week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
36.0 23.1 33.3 42.3
12.Secondary Outcome
Title Percentage of Participants Who Achieved a PPSI-90 Response
Hide Description PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. 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 nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 1.9 1.9
Week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 3.8
Week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 3.7 3.8
Week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 11.5 3.7 7.7
Week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 7.7 1.9 9.6
Week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 7.7 5.6 9.6
Week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
12.0 7.7 16.7 11.5
Week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
16.0 7.7 11.1 17.3
Week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
20.0 11.5 16.7 17.3
13.Secondary Outcome
Title Percentage of Participants Who Achieved a PPSI-100 Response
Hide Description PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. 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 100 response represents participants who achieved at least a 100% 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 nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at Week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 0
Week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 0
Week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 3.8
Week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 3.8
Week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 0 0 1.9
Week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 0 5.6 1.9
Week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 0 3.7 5.8
Week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 11.1 5.8
14.Secondary Outcome
Title Percentage of Participants in Each Categories of Physician’s Global Assessment (PGA) Score
Hide 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 nonresponders at week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2: Clear (0) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 2: Almost clear (1) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 2: Mild (2) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
5.7 1.9 7.7
Week 2: Moderate (3) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
39.6 46.3 44.2
Week 2: Severe (4) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
47.2 48.1 36.5
Week 2: Very severe (5) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
7.5 3.7 11.5
Week 4: Clear (0) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 4: Almost clear (1) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 4: Mild (2) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
7.5 5.6 9.6
Week 4: Moderate (3) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
39.6 53.7 38.5
Week 4: Severe (4) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
45.3 38.9 48.1
Week 4: Very severe (5) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
7.5 1.9 3.8
Week 8: Clear (0) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 8: Almost clear (1) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 8: Mild (2) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
15.1 18.5 11.5
Week 8: Moderate (3) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
37.7 61.1 48.1
Week 8: Severe (4) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
41.5 20.4 36.5
Week 8: Very severe (5) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
5.7 0 1.9
Week 12: Clear (0) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 12: Almost clear (1) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 3.8
Week 12: Mild (2) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
17.0 31.5 17.3
Week 12: Moderate (3) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
43.4 48.1 44.2
Week 12: Severe (4) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
32.1 20.4 30.8
Week 12: Very severe (5) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
7.5 0 1.9
Week 16: Clear (0) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 16: Almost clear (1) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
5.7 7.4 0
Week 16: Mild (2) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
15.1 38.9 25.0
Week 16: Moderate (3) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
43.4 44.4 50.0
Week 16: Severe (4) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
28.3 9.3 19.2
Week 16: Very severe (5) Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
7.5 0 3.8
Week 20: Clear (0) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 0
Week 20: Almost clear (1) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 9.3 7.7
Week 20: Mild (2) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
28.0 23.1 38.9 25.0
Week 20: Moderate (3) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
32.0 42.3 44.4 53.8
Week 20: Severe (4) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
28.0 23.1 7.4 9.6
Week 20: Very severe (5) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 7.7 0 3.8
Week 24: Clear (0) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 24: Almost clear (1) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 14.8 13.5
Week 24: Mild (2) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
36.0 42.3 40.7 42.7
Week 24: Moderate (3) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
36.0 26.9 37.0 42.3
Week 24: Severe (4) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
16.0 23.1 7.4 7.7
Week 24: Very severe (5) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 3.8 0 1.9
Week 28: Clear (0) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 3.8
Week 28: Almost clear (1) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 14.8 13.5
Week 28: Mild (2) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
28.0 46.2 46.3 40.4
Week 28: Moderate (3) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
48.0 23.1 33.3 38.5
Week 28: Severe (4) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
12.0 26.9 5.6 1.9
Week 28: Very severe (5) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 0 0 1.9
Week 32: Clear (0) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 32: Almost clear (1) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 11.5 16.7 23.1
Week 32: Mild (2) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
32.0 46.2 46.3 36.5
Week 32: Moderate (3) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
48.0 26.9 31.5 26.9
Week 32: Severe (4) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
12.0 15.4 5.6 9.6
Week 32: Very severe (5) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 36: Clear (0) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 36: Almost clear (1) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
12.0 19.2 22.2 23.1
Week 36: Mild (2) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
36.0 42.3 44.4 38.5
Week 36: Moderate (3) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
32.0 30.8 29.6 30.8
Week 36: Severe (4) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
20.0 7.7 3.7 3.8
Week 36: Very severe (5) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 40: Clear (0) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 40: Almost clear (1) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
20.0 23.1 24.1 26.9
Week 40: Mild (2) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
28.0 38.5 37.0 38.5
Week 40: Moderate (3) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
36.0 30.8 33.0 28.8
Week 40: Severe (4) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
16.0 7.7 5.6 1.9
Week 40: Very severe (5) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 44: Clear (0) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 0 3.7 1.9
Week 44: Almost clear (1) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
24.0 15.4 24.1 32.7
Week 44: Mild (2) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
24.0 50.0 40.7 32.7
Week 44: Moderate (3) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
28.0 30.8 25.9 26.9
Week 44: Severe (4) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
20.0 3.8 5.6 3.8
Week 44: Very severe (5) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 48: Clear (0) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 0 1.9 3.8
Week 48: Almost clear (1) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
32.0 26.9 29.6 25.0
Week 48: Mild (2) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 38.5 35.2 50.0
Week48: Moderate (3) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
40.0 30.8 27.0 15.4
Week 48: Severe (4) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
16.0 3.8 5.6 3.8
Week 48: Very severe (5) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
Week 52: Clear (0) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
4.0 3.8 7.4 3.8
Week 52: Almost clear (1) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
28.0 23.1 24.1 21.2
Week 52: Mild (2) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
20.0 50.0 40.7 51.9
Week 52: Moderate (3) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
32.0 19.2 24.1 21.2
Week 52: Severe (4) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
16.0 3.8 3.7 0
Week 52: Very severe (5) Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
0 0 0 1.9
15.Secondary Outcome
Title Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Hide Description The PGA documents the Physician’s Global Assessment of the participants’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 nonresponders through Week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 5.8
Week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
5.7 7.4 1.9
Week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 9.3 7.7
Week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 14.8 15.4
Week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 14.8 17.3
Week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 11.5 16.7 25.0
Week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
12.0 19.2 22.2 25.0
Week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
20.0 23.1 24.1 28.8
Week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
28.0 15.4 27.8 34.6
Week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
36.0 26.9 31.5 28.8
Week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
32.0 26.9 31.5 25.0
16.Secondary Outcome
Title Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Hide 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 nonresponders through Week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 4 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 0
Week 8 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 1.9
Week 12 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
0 0 5.8
Week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
5.7 7.4 1.9
Week 20 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 9.3 7.7
Week 24 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 14.8 15.4
Week 28 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 3.8 14.8 17.3
Week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0 11.5 16.7 25.0
Week 36 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
12.0 19.2 22.2 25.0
Week 40 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
20.0 23.1 24.1 28.8
Week 44 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
28.0 15.4 27.8 34.6
Week 48 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
36.0 26.9 31.5 28.8
Week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
32.0 26.9 31.5 25.0
17.Secondary Outcome
Title Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
Hide Description The DLQI is a dermatology-specific uality 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.
Time Frame Baseline, week 16, 32 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
-1.8  (4.71) -5.0  (5.59) -3.1  (3.49)
Change at week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-4.3  (5.25) -4.2  (5.09) -5.2  (5.90) -4.2  (4.18)
Change at week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
-4.8  (5.74) -5.2  (5.10) -5.7  (6.05) -4.9  (5.24)
18.Secondary Outcome
Title Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score
Hide Description SF-36 consists of 8 individual domains, which are weighted sums of the 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 the scale scores, the 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 the post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Baseline, week 16, 32 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
1.27  (9.177) 4.67  (13.753) 3.34  (10.259)
Change at week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
5.46  (16.226) 7.16  (11.507) 8.31  (15.510) 4.82  (9.975)
Change at week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
7.92  (14.580) 8.18  (11.320) 7.35  (17.320) 6.47  (11.466)
19.Secondary Outcome
Title Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score
Hide Description SF-36 consists of 8 individual domains, which are weighted sums of the 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 the scale scores, the summary MCS is derived. Scales contributing most to the scoring of the SF-36 MCS include VT,SF,RE and MH. 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 MCS 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 the post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF.
Time Frame Baseline, week 16, 32 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
1.20  (7.823) 0.64  (7.880) 0.66  (7.055)
Change at week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
2.19  (10.277) 1.10  (7.579) 0.52  (8.124) 0.59  (7.639)
Change at week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
1.44  (9.980) 0.39  (7.431) 1.69  (7.866) 0.69  (7.354)
20.Secondary Outcome
Title Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score
Hide 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.
Time Frame Baseline, week 16, 32 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all randomized participants at week 0 or 16, regardless of whether or not they received study treatment and had any post-baseline efficacy assessment. The missing values were imputed based on TF criterion and LOCF method.
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60.
Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
Overall Number of Participants Analyzed 53 25 26 54 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at week 16 Number Analyzed 53 participants 0 participants 0 participants 54 participants 52 participants
-0.1  (14.33) 8.3  (21.25) 8.5  (15.59)
Change at week 32 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
8.0  (25.36) 6.5  (15.75) 10.2  (21.88) 5.9  (15.98)
Change at week 52 Number Analyzed 0 participants 25 participants 26 participants 54 participants 52 participants
13.0  (24.69) 5.6  (16.28) 13.9  (22.19) 7.9  (15.19)
Time Frame Baseline (Week 0) up to Week 52
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Hide Arm/Group Description Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 during placebo controlled period (PCP). At Week 16 placebo participants were randomized to receive guselkumab 200 milligram (mg) or 100 mg. Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60. Participants who received placebo matched to guselkumab SC injection through Week 16 during placebo controlled period were crossed over to receive guselkumab 200 mg SC injection at Weeks 16 and 20 and once every 8 Weeks thereafter through Week 60. Participants received guselkumab 100 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and once every 8 Weeks thereafter through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind.
All-Cause Mortality
Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/25 (0.00%)   0/26 (0.00%)   0/54 (0.00%)   0/52 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/53 (3.77%)   1/25 (4.00%)   0/26 (0.00%)   3/54 (5.56%)   2/52 (3.85%) 
Cardiac disorders           
Angina Pectoris * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/54 (1.85%)  0/52 (0.00%) 
Gastrointestinal disorders           
Large Intestine Polyp * 1  1/53 (1.89%)  0/25 (0.00%)  0/26 (0.00%)  0/54 (0.00%)  1/52 (1.92%) 
Injury, poisoning and procedural complications           
Heat Stroke * 1  1/53 (1.89%)  0/25 (0.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Synovial Rupture * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/54 (1.85%)  0/52 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Gastric Cancer * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Lung Carcinoma Cell Type Unspecified Stage 0 * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/54 (1.85%)  0/52 (0.00%) 
Surgical and medical procedures           
Abortion Induced * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/54 (0.00%)  1/52 (1.92%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Placebo Then Guselkumab 100 mg Placebo Then Guselkumab 200 mg Guselkumab 100 mg Guselkumab 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/53 (64.15%)   22/25 (88.00%)   21/26 (80.77%)   41/54 (75.93%)   46/52 (88.46%) 
Blood and lymphatic system disorders           
Anaemia * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  2/54 (3.70%)  0/52 (0.00%) 
Cardiac disorders           
Ventricular Extrasystoles * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  0/52 (0.00%) 
Ear and labyrinth disorders           
Deafness Neurosensory * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  2/54 (3.70%)  0/52 (0.00%) 
Vertigo * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  1/52 (1.92%) 
Eye disorders           
Corneal Perforation * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Gastrointestinal disorders           
Abdominal Pain Upper * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  4/54 (7.41%)  1/52 (1.92%) 
Cheilitis * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/54 (0.00%)  2/52 (3.85%) 
Constipation * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/54 (1.85%)  2/52 (3.85%) 
Dental Caries * 1  2/53 (3.77%)  2/25 (8.00%)  1/26 (3.85%)  4/54 (7.41%)  4/52 (7.69%) 
Diarrhoea * 1  1/53 (1.89%)  1/25 (4.00%)  1/26 (3.85%)  3/54 (5.56%)  1/52 (1.92%) 
Gastric Ulcer * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Gastritis * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  2/54 (3.70%)  1/52 (1.92%) 
Gastrooesophageal Reflux Disease * 1  0/53 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  1/54 (1.85%)  1/52 (1.92%) 
General disorders           
Fatigue * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/54 (1.85%)  2/52 (3.85%) 
Injection Site Erythema * 1  0/53 (0.00%)  2/25 (8.00%)  5/26 (19.23%)  4/54 (7.41%)  10/52 (19.23%) 
Injection Site Induration * 1  0/53 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  1/54 (1.85%)  1/52 (1.92%) 
Injection Site Pruritus * 1  1/53 (1.89%)  1/25 (4.00%)  3/26 (11.54%)  1/54 (1.85%)  5/52 (9.62%) 
Injection Site Swelling * 1  0/53 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  2/54 (3.70%)  3/52 (5.77%) 
Malaise * 1  1/53 (1.89%)  1/25 (4.00%)  0/26 (0.00%)  1/54 (1.85%)  1/52 (1.92%) 
Infections and infestations           
Bronchitis * 1  0/53 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  2/54 (3.70%)  0/52 (0.00%) 
Conjunctivitis * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  1/54 (1.85%)  0/52 (0.00%) 
Cystitis * 1  1/53 (1.89%)  2/25 (8.00%)  2/26 (7.69%)  3/54 (5.56%)  0/52 (0.00%) 
Folliculitis * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  2/54 (3.70%)  1/52 (1.92%) 
Gastroenteritis * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  2/52 (3.85%) 
Gingivitis * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  1/54 (1.85%)  0/52 (0.00%) 
Herpes Simplex * 1  1/53 (1.89%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  0/52 (0.00%) 
Influenza * 1  1/53 (1.89%)  1/25 (4.00%)  0/26 (0.00%)  2/54 (3.70%)  1/52 (1.92%) 
Nasopharyngitis * 1  9/53 (16.98%)  15/25 (60.00%)  12/26 (46.15%)  18/54 (33.33%)  23/52 (44.23%) 
Oral Herpes * 1  2/53 (3.77%)  0/25 (0.00%)  3/26 (11.54%)  0/54 (0.00%)  3/52 (5.77%) 
Pharyngitis * 1  1/53 (1.89%)  0/25 (0.00%)  0/26 (0.00%)  1/54 (1.85%)  2/52 (3.85%) 
Tinea Pedis * 1  2/53 (3.77%)  0/25 (0.00%)  0/26 (0.00%)  5/54 (9.26%)  0/52 (0.00%) 
Tonsillitis * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/54 (1.85%)  2/52 (3.85%) 
Upper Respiratory Tract Infection * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  2/54 (3.70%)  2/52 (3.85%) 
Vaginal Infection * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Injury, poisoning and procedural complications           
Arthropod Bite * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  3/54 (5.56%)  1/52 (1.92%) 
Contusion * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  2/52 (3.85%) 
Ligament Injury * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Ligament Sprain * 1  2/53 (3.77%)  0/25 (0.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Lower Limb Fracture * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  0/52 (0.00%) 
Tooth Fracture * 1  1/53 (1.89%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  0/52 (0.00%) 
Traumatic Ulcer * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Metabolism and nutrition disorders           
Diabetes Mellitus * 1  2/53 (3.77%)  1/25 (4.00%)  0/26 (0.00%)  1/54 (1.85%)  0/52 (0.00%) 
Hyperlipidaemia * 1  0/53 (0.00%)  3/25 (12.00%)  0/26 (0.00%)  2/54 (3.70%)  1/52 (1.92%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  3/53 (5.66%)  0/25 (0.00%)  0/26 (0.00%)  4/54 (7.41%)  5/52 (9.62%) 
Back Pain * 1  2/53 (3.77%)  0/25 (0.00%)  0/26 (0.00%)  1/54 (1.85%)  0/52 (0.00%) 
Intervertebral Disc Protrusion * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Musculoskeletal Pain * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  2/52 (3.85%) 
Musculoskeletal Stiffness * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  1/54 (1.85%)  0/52 (0.00%) 
Osteoarthritis * 1  1/53 (1.89%)  0/25 (0.00%)  0/26 (0.00%)  1/54 (1.85%)  3/52 (5.77%) 
Periarthritis * 1  0/53 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  0/54 (0.00%)  0/52 (0.00%) 
Peripheral Arthritis * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/54 (0.00%)  2/52 (3.85%) 
Polyarthritis * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Tenosynovitis * 1  0/53 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  1/54 (1.85%)  0/52 (0.00%) 
Nervous system disorders           
Headache * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  2/54 (3.70%)  4/52 (7.69%) 
Hypoaesthesia * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  2/52 (3.85%) 
Somnolence * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/54 (1.85%)  0/52 (0.00%) 
Reproductive system and breast disorders           
Benign Prostatic Hyperplasia * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  0/52 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  2/54 (3.70%)  0/52 (0.00%) 
Obstructive Airways Disorder * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  0/52 (0.00%) 
Skin and subcutaneous tissue disorders           
Chronic Pigmented Purpura * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  0/52 (0.00%) 
Dermal Cyst * 1  1/53 (1.89%)  0/25 (0.00%)  0/26 (0.00%)  2/54 (3.70%)  1/52 (1.92%) 
Dermatitis * 1  2/53 (3.77%)  0/25 (0.00%)  0/26 (0.00%)  1/54 (1.85%)  1/52 (1.92%) 
Dermatitis Contact * 1  2/53 (3.77%)  2/25 (8.00%)  1/26 (3.85%)  2/54 (3.70%)  1/52 (1.92%) 
Eczema * 1  3/53 (5.66%)  1/25 (4.00%)  0/26 (0.00%)  6/54 (11.11%)  8/52 (15.38%) 
Eczema Asteatotic * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  2/54 (3.70%)  2/52 (3.85%) 
Eczema Nummular * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  0/52 (0.00%) 
Erythema * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  3/52 (5.77%) 
Erythema Multiforme * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  0/52 (0.00%) 
Erythema Nodosum * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Hyperkeratosis * 1  0/53 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  1/54 (1.85%)  2/52 (3.85%) 
Ingrowing Nail * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/54 (0.00%)  3/52 (5.77%) 
Papule * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Polymorphic Light Eruption * 1  0/53 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/54 (0.00%)  0/52 (0.00%) 
Pruritus * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/54 (0.00%)  3/52 (5.77%) 
Pustular Psoriasis * 1  4/53 (7.55%)  2/25 (8.00%)  0/26 (0.00%)  4/54 (7.41%)  0/52 (0.00%) 
Rash * 1  0/53 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/54 (0.00%)  3/52 (5.77%) 
Skin Discomfort * 1  0/53 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Urticaria * 1  1/53 (1.89%)  1/25 (4.00%)  1/26 (3.85%)  2/54 (3.70%)  5/52 (9.62%) 
Vascular disorders           
Hypertension * 1  2/53 (3.77%)  1/25 (4.00%)  0/26 (0.00%)  0/54 (0.00%)  1/52 (1.92%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: Senior Director, Immunology General
Organization: Janssen Pharmaceutical K.K.
Phone: 844-434-4210
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT02641730     History of Changes
Other Study ID Numbers: CR108046
CNTO1959PPP3001 ( Other Identifier: Janssen Pharmaceutical K.K. )
First Submitted: December 14, 2015
First Posted: December 29, 2015
Results First Submitted: August 22, 2018
Results First Posted: February 21, 2019
Last Update Posted: February 21, 2019