Trial Outcomes & Findings for An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis (NCT NCT02641730)
NCT ID: NCT02641730
Last Updated: 2025-02-04
Results Overview
PPPASI assesses severity of palmoplantar pustulosis (PPP) lesions and response to therapy. In PPPASI, palms, soles are divided into 4 regions: right palm(RP), left palm(LP), right sole(RS), left sole(LS), that account for 20 percent (%), 20%,30%,30%, respectively, of total surface area(TSA) of palms, soles. Each area is assessed separately for erythema(E), pustules/vesicles (P), desquamation/scales (D), each rated on a scale (0-4). PPPASI produces score range of 0-72 using formula, PPPASI=(E+P+D)Area\*0.2(RP)+(E+P+D)Area\*0.2 (LP)+(E+P+D)Area\*0.3(RS)+(E+P+D)Area\*0.3(LS). Higher a score more the severe disease. Participants who discontinue study agent as they met treatment failure(TF) criterion(lack of efficacy/AE of worsening of PPP/who started a protocol-prohibited medication/therapy that could improve PPP), their baseline value carried forward to post baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
159 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
Placebo
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.
|
Placebo Then Guselkumab 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 Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Placebo Then Guselkumab 200 mg
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 Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Placebo Controlled Period (Week 0 - 16)
STARTED
|
53
|
0
|
0
|
54
|
52
|
|
Placebo Controlled Period (Week 0 - 16)
COMPLETED
|
51
|
0
|
0
|
53
|
50
|
|
Placebo Controlled Period (Week 0 - 16)
NOT COMPLETED
|
2
|
0
|
0
|
1
|
2
|
|
After Controlled Period (Week 16 - 52)
STARTED
|
0
|
25
|
26
|
53
|
50
|
|
After Controlled Period (Week 16 - 52)
COMPLETED
|
0
|
21
|
24
|
45
|
44
|
|
After Controlled Period (Week 16 - 52)
NOT COMPLETED
|
0
|
4
|
2
|
8
|
6
|
|
Observational Period (Week 60 - Week 84)
STARTED
|
0
|
21
|
24
|
45
|
44
|
|
Observational Period (Week 60 - Week 84)
COMPLETED
|
0
|
21
|
24
|
45
|
43
|
|
Observational Period (Week 60 - Week 84)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
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.
|
Placebo Then Guselkumab 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 Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Placebo Then Guselkumab 200 mg
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 Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Placebo Controlled Period (Week 0 - 16)
Adverse Event
|
2
|
0
|
0
|
1
|
2
|
|
After Controlled Period (Week 16 - 52)
Adverse Event
|
0
|
1
|
1
|
5
|
4
|
|
After Controlled Period (Week 16 - 52)
Lack of Efficacy
|
0
|
2
|
0
|
2
|
0
|
|
After Controlled Period (Week 16 - 52)
Pregnancy
|
0
|
0
|
0
|
1
|
1
|
|
After Controlled Period (Week 16 - 52)
Other
|
0
|
1
|
1
|
0
|
1
|
|
Observational Period (Week 60 - Week 84)
Other
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
Baseline characteristics by cohort
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 8.14 • n=5 Participants
|
53.9 years
STANDARD_DEVIATION 10.88 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 10.94 • n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
JAPAN
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Randomized analysis set: all randomized participants at Week 0, whether they received study treatment or not and had any post-baseline efficacy assessment. Missing values were imputed based on TF criterion, last observation carried forward (LOCF) method till Week 60;no imputation performed for missing data after Week 60 (in observational period).
PPPASI assesses severity of palmoplantar pustulosis (PPP) lesions and response to therapy. In PPPASI, palms, soles are divided into 4 regions: right palm(RP), left palm(LP), right sole(RS), left sole(LS), that account for 20 percent (%), 20%,30%,30%, respectively, of total surface area(TSA) of palms, soles. Each area is assessed separately for erythema(E), pustules/vesicles (P), desquamation/scales (D), each rated on a scale (0-4). PPPASI produces score range of 0-72 using formula, PPPASI=(E+P+D)Area\*0.2(RP)+(E+P+D)Area\*0.2 (LP)+(E+P+D)Area\*0.3(RS)+(E+P+D)Area\*0.3(LS). Higher a score more the severe disease. Participants who discontinue study agent as they met treatment failure(TF) criterion(lack of efficacy/AE of worsening of PPP/who started a protocol-prohibited medication/therapy that could improve PPP), their baseline value carried forward to post baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16
|
-7.79 Units on a scale
Standard Deviation 10.596
|
-15.08 Units on a scale
Standard Deviation 11.252
|
-11.07 Units on a scale
Standard Deviation 7.779
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Population included Randomized analysis set. The missing values were imputed based on Treatment Failure (TF) criterion and last scheduled observation carried forward (LOCF) method until Week 60; no imputation performed for missing data after Week 60 (in observational period).
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16
|
-2.0 Units on a scale
Standard Deviation 2.41
|
-3.9 Units on a scale
Standard Deviation 2.94
|
-3.0 Units on a scale
Standard Deviation 2.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period).
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16
|
34.0 Percentage of participants
|
57.4 Percentage of participants
|
36.5 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, which account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Change From Baseline in PPPASI Total Score
Change at week 2
|
-3.58 Units on a scale
Standard Deviation 5.303
|
—
|
—
|
-2.27 Units on a scale
Standard Deviation 6.832
|
-3.02 Units on a scale
Standard Deviation 5.829
|
|
Change From Baseline in PPPASI Total Score
Change at week 4
|
-4.39 Units on a scale
Standard Deviation 6.805
|
—
|
—
|
-6.43 Units on a scale
Standard Deviation 7.907
|
-5.28 Units on a scale
Standard Deviation 5.692
|
|
Change From Baseline in PPPASI Total Score
Change at week 8
|
-6.31 Units on a scale
Standard Deviation 7.986
|
—
|
—
|
-10.60 Units on a scale
Standard Deviation 8.358
|
-7.94 Units on a scale
Standard Deviation 7.305
|
|
Change From Baseline in PPPASI Total Score
Change at week 12
|
-7.60 Units on a scale
Standard Deviation 9.197
|
—
|
—
|
-12.80 Units on a scale
Standard Deviation 9.706
|
-9.35 Units on a scale
Standard Deviation 8.121
|
|
Change From Baseline in PPPASI Total Score
Change at week 20
|
—
|
-12.33 Units on a scale
Standard Deviation 9.672
|
-8.66 Units on a scale
Standard Deviation 11.032
|
-16.33 Units on a scale
Standard Deviation 11.350
|
-13.76 Units on a scale
Standard Deviation 8.278
|
|
Change From Baseline in PPPASI Total Score
Change at week 24
|
—
|
-14.45 Units on a scale
Standard Deviation 9.878
|
-10.90 Units on a scale
Standard Deviation 10.759
|
-17.86 Units on a scale
Standard Deviation 11.219
|
-15.38 Units on a scale
Standard Deviation 8.864
|
|
Change From Baseline in PPPASI Total Score
Change at week 28
|
—
|
-15.44 Units on a scale
Standard Deviation 10.597
|
-13.90 Units on a scale
Standard Deviation 11.383
|
-18.32 Units on a scale
Standard Deviation 11.425
|
-16.86 Units on a scale
Standard Deviation 9.443
|
|
Change From Baseline in PPPASI Total Score
Change at week 32
|
—
|
-16.92 Units on a scale
Standard Deviation 10.615
|
-15.63 Units on a scale
Standard Deviation 10.789
|
-18.52 Units on a scale
Standard Deviation 11.544
|
-17.64 Units on a scale
Standard Deviation 9.792
|
|
Change From Baseline in PPPASI Total Score
Change at week 36
|
—
|
-18.15 Units on a scale
Standard Deviation 11.372
|
-17.19 Units on a scale
Standard Deviation 11.199
|
-18.87 Units on a scale
Standard Deviation 11.909
|
-17.72 Units on a scale
Standard Deviation 10.083
|
|
Change From Baseline in PPPASI Total Score
Change at week 40
|
—
|
-19.06 Units on a scale
Standard Deviation 11.683
|
-18.63 Units on a scale
Standard Deviation 10.812
|
-18.85 Units on a scale
Standard Deviation 12.356
|
-18.54 Units on a scale
Standard Deviation 9.887
|
|
Change From Baseline in PPPASI Total Score
Change at week 44
|
—
|
-18.92 Units on a scale
Standard Deviation 12.099
|
-18.77 Units on a scale
Standard Deviation 11.119
|
-18.91 Units on a scale
Standard Deviation 12.338
|
-18.61 Units on a scale
Standard Deviation 10.093
|
|
Change From Baseline in PPPASI Total Score
Change at week 48
|
—
|
-19.54 Units on a scale
Standard Deviation 12.572
|
-19.18 Units on a scale
Standard Deviation 10.547
|
-19.72 Units on a scale
Standard Deviation 12.506
|
-18.99 Units on a scale
Standard Deviation 9.686
|
|
Change From Baseline in PPPASI Total Score
Change at week 52
|
—
|
-20.04 Units on a scale
Standard Deviation 12.362
|
-18.88 Units on a scale
Standard Deviation 11.635
|
-19.95 Units on a scale
Standard Deviation 12.567
|
-19.63 Units on a scale
Standard Deviation 9.776
|
|
Change From Baseline in PPPASI Total Score
Change at week 60
|
—
|
-20.18 Units on a scale
Standard Deviation 11.880
|
-19.62 Units on a scale
Standard Deviation 11.566
|
-20.17 Units on a scale
Standard Deviation 12.829
|
-20.37 Units on a scale
Standard Deviation 10.098
|
|
Change From Baseline in PPPASI Total Score
Change at week 72
|
—
|
-22.09 Units on a scale
Standard Deviation 11.958
|
-21.08 Units on a scale
Standard Deviation 11.855
|
-22.13 Units on a scale
Standard Deviation 10.400
|
-22.05 Units on a scale
Standard Deviation 9.136
|
|
Change From Baseline in PPPASI Total Score
Change at week 84
|
—
|
-22.60 Units on a scale
Standard Deviation 11.781
|
-21.19 Units on a scale
Standard Deviation 13.619
|
-21.32 Units on a scale
Standard Deviation 10.458
|
-22.56 Units on a scale
Standard Deviation 9.352
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Change From Baseline in PPSI Total Score
Change at week 36
|
—
|
-4.8 Units on a scale
Standard Deviation 3.14
|
-4.7 Units on a scale
Standard Deviation 3.39
|
-4.9 Units on a scale
Standard Deviation 2.89
|
-5.8 Units on a scale
Standard Deviation 3.18
|
|
Change From Baseline in PPSI Total Score
Change at week 40
|
—
|
-5.0 Units on a scale
Standard Deviation 3.35
|
-5.3 Units on a scale
Standard Deviation 3.12
|
-5.1 Units on a scale
Standard Deviation 3.10
|
-5.9 Units on a scale
Standard Deviation 3.01
|
|
Change From Baseline in PPSI Total Score
Change at week 44
|
—
|
-5.0 Units on a scale
Standard Deviation 3.55
|
-5.5 Units on a scale
Standard Deviation 2.89
|
-5.2 Units on a scale
Standard Deviation 3.30
|
-5.9 Units on a scale
Standard Deviation 3.14
|
|
Change From Baseline in PPSI Total Score
Change at week 48
|
—
|
-5.3 Units on a scale
Standard Deviation 3.58
|
-5.5 Units on a scale
Standard Deviation 2.90
|
-5.3 Units on a scale
Standard Deviation 3.20
|
-6.3 Units on a scale
Standard Deviation 3.17
|
|
Change From Baseline in PPSI Total Score
Change at week 52
|
—
|
-5.6 Units on a scale
Standard Deviation 3.51
|
-5.6 Units on a scale
Standard Deviation 3.00
|
-5.7 Units on a scale
Standard Deviation 3.12
|
-6.6 Units on a scale
Standard Deviation 3.17
|
|
Change From Baseline in PPSI Total Score
Change at week 60
|
—
|
-5.5 Units on a scale
Standard Deviation 3.19
|
-6.0 Units on a scale
Standard Deviation 3.06
|
-5.6 Units on a scale
Standard Deviation 3.18
|
-6.9 Units on a scale
Standard Deviation 3.25
|
|
Change From Baseline in PPSI Total Score
Change at week 72
|
—
|
-6.5 Units on a scale
Standard Deviation 2.64
|
-6.6 Units on a scale
Standard Deviation 2.65
|
-6.3 Units on a scale
Standard Deviation 2.59
|
-7.7 Units on a scale
Standard Deviation 2.78
|
|
Change From Baseline in PPSI Total Score
Change at week 84
|
—
|
-7.5 Units on a scale
Standard Deviation 2.80
|
-6.6 Units on a scale
Standard Deviation 3.45
|
-6.0 Units on a scale
Standard Deviation 2.89
|
-8.0 Units on a scale
Standard Deviation 2.79
|
|
Change From Baseline in PPSI Total Score
Change at week 2
|
-0.5 Units on a scale
Standard Deviation 1.14
|
—
|
—
|
-0.5 Units on a scale
Standard Deviation 1.68
|
-0.6 Units on a scale
Standard Deviation 1.35
|
|
Change From Baseline in PPSI Total Score
Change at week 4
|
-0.7 Units on a scale
Standard Deviation 1.26
|
—
|
—
|
-1.5 Units on a scale
Standard Deviation 2.14
|
-1.3 Units on a scale
Standard Deviation 1.94
|
|
Change From Baseline in PPSI Total Score
Change at week 8
|
-1.2 Units on a scale
Standard Deviation 1.70
|
—
|
—
|
-2.6 Units on a scale
Standard Deviation 2.48
|
-2.0 Units on a scale
Standard Deviation 2.17
|
|
Change From Baseline in PPSI Total Score
Change at week 12
|
-1.7 Units on a scale
Standard Deviation 2.20
|
—
|
—
|
-3.3 Units on a scale
Standard Deviation 2.53
|
-2.5 Units on a scale
Standard Deviation 2.58
|
|
Change From Baseline in PPSI Total Score
Change at week 20
|
—
|
-3.1 Units on a scale
Standard Deviation 2.55
|
-2.6 Units on a scale
Standard Deviation 2.76
|
-4.0 Units on a scale
Standard Deviation 3.09
|
-3.8 Units on a scale
Standard Deviation 2.68
|
|
Change From Baseline in PPSI Total Score
Change at week 24
|
—
|
-3.7 Units on a scale
Standard Deviation 2.35
|
-3.0 Units on a scale
Standard Deviation 3.15
|
-4.5 Units on a scale
Standard Deviation 2.88
|
-4.6 Units on a scale
Standard Deviation 2.71
|
|
Change From Baseline in PPSI Total Score
Change at week 28
|
—
|
-3.8 Units on a scale
Standard Deviation 2.69
|
-3.9 Units on a scale
Standard Deviation 3.22
|
-4.6 Units on a scale
Standard Deviation 2.89
|
-5.2 Units on a scale
Standard Deviation 2.79
|
|
Change From Baseline in PPSI Total Score
Change at week 32
|
—
|
-3.9 Units on a scale
Standard Deviation 2.68
|
-4.5 Units on a scale
Standard Deviation 3.28
|
-4.7 Units on a scale
Standard Deviation 3.07
|
-5.6 Units on a scale
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 44
|
—
|
64.0 Percentage of participants
|
76.9 Percentage of participants
|
79.6 Percentage of participants
|
76.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 2
|
1.9 Percentage of participants
|
—
|
—
|
3.7 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 4
|
5.7 Percentage of participants
|
—
|
—
|
9.3 Percentage of participants
|
11.5 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 8
|
11.3 Percentage of participants
|
—
|
—
|
29.6 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 12
|
26.4 Percentage of participants
|
—
|
—
|
48.1 Percentage of participants
|
30.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 20
|
—
|
52.0 Percentage of participants
|
42.3 Percentage of participants
|
64.8 Percentage of participants
|
51.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 48
|
—
|
68.0 Percentage of participants
|
84.6 Percentage of participants
|
83.3 Percentage of participants
|
80.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 24
|
—
|
56.0 Percentage of participants
|
42.3 Percentage of participants
|
79.6 Percentage of participants
|
59.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 28
|
—
|
56.0 Percentage of participants
|
65.4 Percentage of participants
|
74.1 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 32
|
—
|
68.0 Percentage of participants
|
61.5 Percentage of participants
|
74.1 Percentage of participants
|
73.1 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 36
|
—
|
64.4 Percentage of participants
|
73.1 Percentage of participants
|
81.5 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 40
|
—
|
68.0 Percentage of participants
|
76.9 Percentage of participants
|
81.5 Percentage of participants
|
80.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 52
|
—
|
76.0 Percentage of participants
|
73.1 Percentage of participants
|
83.3 Percentage of participants
|
84.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 60
|
—
|
80.0 Percentage of participants
|
80.8 Percentage of participants
|
79.6 Percentage of participants
|
84.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 72
|
—
|
90.5 Percentage of participants
|
83.3 Percentage of participants
|
88.9 Percentage of participants
|
93.2 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-50 Response
Week 84
|
—
|
85.7 Percentage of participants
|
87.5 Percentage of participants
|
88.9 Percentage of participants
|
95.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-75 response represents participants who achieved at least a 75% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 60
|
—
|
40.0 Percentage of participants
|
50.0 Percentage of participants
|
63.0 Percentage of participants
|
69.2 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 72
|
—
|
52.4 Percentage of participants
|
66.7 Percentage of participants
|
73.3 Percentage of participants
|
72.7 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 84
|
—
|
61.9 Percentage of participants
|
66.7 Percentage of participants
|
68.9 Percentage of participants
|
81.4 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 2
|
0 Percentage of participants
|
—
|
—
|
1.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 4
|
0 Percentage of participants
|
—
|
—
|
1.9 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 8
|
1.9 Percentage of participants
|
—
|
—
|
5.6 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 12
|
0 Percentage of participants
|
—
|
—
|
13 Percentage of participants
|
11.5 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 16
|
3.8 Percentage of participants
|
—
|
—
|
20.4 Percentage of participants
|
11.5 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 20
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
24.1 Percentage of participants
|
13.5 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 24
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
27.8 Percentage of participants
|
26.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 28
|
—
|
8.0 Percentage of participants
|
23.1 Percentage of participants
|
42.6 Percentage of participants
|
36.5 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 32
|
—
|
24.0 Percentage of participants
|
30.0 Percentage of participants
|
48.1 Percentage of participants
|
48.1 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 36
|
—
|
36.0 Percentage of participants
|
38.5 Percentage of participants
|
48.1 Percentage of participants
|
55.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 40
|
—
|
44.0 Percentage of participants
|
46.2 Percentage of participants
|
44.4 Percentage of participants
|
57.7 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 44
|
—
|
40.0 Percentage of participants
|
50.0 Percentage of participants
|
50.0 Percentage of participants
|
57.7 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 48
|
—
|
48.0 Percentage of participants
|
50.0 Percentage of participants
|
51.9 Percentage of participants
|
59.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-75 Response
Week 52
|
—
|
44.0 Percentage of participants
|
46.2 Percentage of participants
|
55.6 Percentage of participants
|
59.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-90 response represents participants who achieved at least a 90% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 2
|
0 Percentage of participants
|
—
|
—
|
1.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 4
|
0 Percentage of participants
|
—
|
—
|
1.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 8
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 12
|
0 Percentage of participants
|
—
|
—
|
1.9 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 16
|
0 Percentage of participants
|
—
|
—
|
1.9 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 20
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
5.6 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 28
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
11.1 Percentage of participants
|
11.5 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 24
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
9.3 Percentage of participants
|
9.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 84
|
—
|
47.6 Percentage of participants
|
41.7 Percentage of participants
|
31.1 Percentage of participants
|
51.2 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 32
|
—
|
0 Percentage of participants
|
11.5 Percentage of participants
|
14.8 Percentage of participants
|
19.2 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 40
|
—
|
16.0 Percentage of participants
|
15.4 Percentage of participants
|
16.7 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 36
|
—
|
8.0 Percentage of participants
|
11.5 Percentage of participants
|
16.7 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 44
|
—
|
20.0 Percentage of participants
|
15.4 Percentage of participants
|
20.4 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 48
|
—
|
28.0 Percentage of participants
|
26.9 Percentage of participants
|
24.1 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 52
|
—
|
32.0 Percentage of participants
|
23.1 Percentage of participants
|
29.6 Percentage of participants
|
36.5 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 60
|
—
|
20.0 Percentage of participants
|
34.6 Percentage of participants
|
35.2 Percentage of participants
|
44.2 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-90 Response
Week 72
|
—
|
28.6 Percentage of participants
|
29.2 Percentage of participants
|
37.8 Percentage of participants
|
52.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-100 response represents participants who achieved at least a 100% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 20
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 24
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 2
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 4
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 8
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 12
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 28
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 16
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 32
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 36
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 40
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 44
|
—
|
4.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 48
|
—
|
4.0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 52
|
—
|
4.0 Percentage of participants
|
3.8 Percentage of participants
|
7.4 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 60
|
—
|
4.0 Percentage of participants
|
3.8 Percentage of participants
|
9.3 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 72
|
—
|
4.8 Percentage of participants
|
0 Percentage of participants
|
8.9 Percentage of participants
|
11.4 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPPASI-100 Response
Week 84
|
—
|
4.8 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
14.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 36
|
—
|
48.0 Percentage of participants
|
46.2 Percentage of participants
|
48.1 Percentage of participants
|
63.5 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 2
|
0 Percentage of participants
|
—
|
—
|
1.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 4
|
0 Percentage of participants
|
—
|
—
|
9.3 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 8
|
0 Percentage of participants
|
—
|
—
|
24.1 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 12
|
7.5 Percentage of participants
|
—
|
—
|
27.8 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 16
|
11.3 Percentage of participants
|
—
|
—
|
35.2 Percentage of participants
|
19.2 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 20
|
—
|
24.0 Percentage of participants
|
15.4 Percentage of participants
|
38.9 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 24
|
—
|
28.0 Percentage of participants
|
26.9 Percentage of participants
|
48.1 Percentage of participants
|
42.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 28
|
—
|
40.0 Percentage of participants
|
34.6 Percentage of participants
|
50.0 Percentage of participants
|
48.1 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 32
|
—
|
40.0 Percentage of participants
|
46.2 Percentage of participants
|
53.7 Percentage of participants
|
57.7 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 40
|
—
|
48.0 Percentage of participants
|
53.8 Percentage of participants
|
57.4 Percentage of participants
|
63.5 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 44
|
—
|
48.0 Percentage of participants
|
57.7 Percentage of participants
|
50.0 Percentage of participants
|
65.4 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 48
|
—
|
52.0 Percentage of participants
|
50.0 Percentage of participants
|
51.9 Percentage of participants
|
69.2 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 52
|
—
|
52.0 Percentage of participants
|
57.7 Percentage of participants
|
61.1 Percentage of participants
|
69.2 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 60
|
—
|
56.0 Percentage of participants
|
65.4 Percentage of participants
|
61.1 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 72
|
—
|
61.9 Percentage of participants
|
83.3 Percentage of participants
|
71.1 Percentage of participants
|
81.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-50 Response
Week 84
|
—
|
81.0 Percentage of participants
|
79.2 Percentage of participants
|
66.7 Percentage of participants
|
83.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 32
|
—
|
0 Percentage of participants
|
19.2 Percentage of participants
|
16.7 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 2
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 4
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 8
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 12
|
0 Percentage of participants
|
—
|
—
|
5.6 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 16
|
0 Percentage of participants
|
—
|
—
|
11.1 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 20
|
—
|
4.0 Percentage of participants
|
0 Percentage of participants
|
14.8 Percentage of participants
|
9.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 24
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
16.7 Percentage of participants
|
11.5 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 28
|
—
|
0 Percentage of participants
|
11.5 Percentage of participants
|
11.1 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 36
|
—
|
16.0 Percentage of participants
|
19.2 Percentage of participants
|
20.4 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 40
|
—
|
28.0 Percentage of participants
|
26.9 Percentage of participants
|
22.2 Percentage of participants
|
26.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 44
|
—
|
32.0 Percentage of participants
|
23.1 Percentage of participants
|
31.5 Percentage of participants
|
30.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 48
|
—
|
32.0 Percentage of participants
|
26.9 Percentage of participants
|
33.3 Percentage of participants
|
34.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 52
|
—
|
36.0 Percentage of participants
|
23.1 Percentage of participants
|
33.3 Percentage of participants
|
42.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 60
|
—
|
20.0 Percentage of participants
|
30.8 Percentage of participants
|
37.0 Percentage of participants
|
48.1 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 72
|
—
|
33.3 Percentage of participants
|
37.5 Percentage of participants
|
40.0 Percentage of participants
|
56.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-75 Response
Week 84
|
—
|
57.1 Percentage of participants
|
45.8 Percentage of participants
|
33.3 Percentage of participants
|
62.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. PPSI 90 response represents participants who achieved at least a 90% improvement from baseline in the PPSI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 2
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 4
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 8
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 12
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 16
|
0 Percentage of participants
|
—
|
—
|
1.9 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 20
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 24
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 28
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
3.7 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 32
|
—
|
0 Percentage of participants
|
11.5 Percentage of participants
|
3.7 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 36
|
—
|
4.0 Percentage of participants
|
7.7 Percentage of participants
|
1.9 Percentage of participants
|
9.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 40
|
—
|
8.0 Percentage of participants
|
7.7 Percentage of participants
|
5.6 Percentage of participants
|
9.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 44
|
—
|
12.0 Percentage of participants
|
7.7 Percentage of participants
|
16.7 Percentage of participants
|
11.5 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 48
|
—
|
16.0 Percentage of participants
|
7.7 Percentage of participants
|
11.1 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 52
|
—
|
20.0 Percentage of participants
|
11.5 Percentage of participants
|
16.7 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 60
|
—
|
20.0 Percentage of participants
|
15.4 Percentage of participants
|
13.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 72
|
—
|
23.8 Percentage of participants
|
16.7 Percentage of participants
|
22.2 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-90 Response
Week 84
|
—
|
28.6 Percentage of participants
|
29.2 Percentage of participants
|
17.8 Percentage of participants
|
32.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 32
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 2
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 4
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 8
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 12
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 16
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 20
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 24
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 28
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 36
|
—
|
4.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 40
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 44
|
—
|
4.0 Percentage of participants
|
0 Percentage of participants
|
5.6 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 48
|
—
|
8.0 Percentage of participants
|
0 Percentage of participants
|
3.7 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 52
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
11.1 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 60
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
9.3 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 72
|
—
|
4.8 Percentage of participants
|
0 Percentage of participants
|
11.1 Percentage of participants
|
15.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PPSI-100 Response
Week 84
|
—
|
9.5 Percentage of participants
|
4.2 Percentage of participants
|
6.7 Percentage of participants
|
20.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
The PGA documents the Physician's Global Assessment of the PPP overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 2: Mild (2)
|
5.7 Percentage of participants
|
—
|
—
|
1.9 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 48: Clear (0)
|
—
|
4.0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 48: Almost clear (1)
|
—
|
32.0 Percentage of participants
|
26.9 Percentage of participants
|
29.6 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 84: Mild (2)
|
—
|
38.1 Percentage of participants
|
29.2 Percentage of participants
|
42.2 Percentage of participants
|
34.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 28: Severe (4)
|
—
|
12.0 Percentage of participants
|
26.9 Percentage of participants
|
5.6 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 28: Very severe (5)
|
—
|
4.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 32: Clear (0)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 32: Almost clear (1)
|
—
|
8.0 Percentage of participants
|
11.5 Percentage of participants
|
16.7 Percentage of participants
|
23.1 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 32: Mild (2)
|
—
|
32.0 Percentage of participants
|
46.2 Percentage of participants
|
46.3 Percentage of participants
|
36.5 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 32: Moderate (3)
|
—
|
48.0 Percentage of participants
|
26.9 Percentage of participants
|
31.5 Percentage of participants
|
26.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 32: Severe (4)
|
—
|
12.0 Percentage of participants
|
15.4 Percentage of participants
|
5.6 Percentage of participants
|
9.6 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 32: Very severe (5)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 36: Clear (0)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 36: Almost clear (1)
|
—
|
12.0 Percentage of participants
|
19.2 Percentage of participants
|
22.2 Percentage of participants
|
23.1 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 36: Mild (2)
|
—
|
36.0 Percentage of participants
|
42.3 Percentage of participants
|
44.4 Percentage of participants
|
38.5 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 36: Moderate (3)
|
—
|
32.0 Percentage of participants
|
30.8 Percentage of participants
|
29.6 Percentage of participants
|
30.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 36: Severe (4)
|
—
|
20.0 Percentage of participants
|
7.7 Percentage of participants
|
3.7 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 36: Very severe (5)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 40: Clear (0)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 40: Almost clear (1)
|
—
|
20.0 Percentage of participants
|
23.1 Percentage of participants
|
24.1 Percentage of participants
|
26.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 40: Mild (2)
|
—
|
28.0 Percentage of participants
|
38.5 Percentage of participants
|
37.0 Percentage of participants
|
38.5 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 40: Moderate (3)
|
—
|
36.0 Percentage of participants
|
30.8 Percentage of participants
|
33.0 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 40: Severe (4)
|
—
|
16.0 Percentage of participants
|
7.7 Percentage of participants
|
5.6 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 40: Very severe (5)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 44: Clear (0)
|
—
|
4.0 Percentage of participants
|
0 Percentage of participants
|
3.7 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 44: Almost clear (1)
|
—
|
24.0 Percentage of participants
|
15.4 Percentage of participants
|
24.1 Percentage of participants
|
32.7 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 44: Mild (2)
|
—
|
24.0 Percentage of participants
|
50.0 Percentage of participants
|
40.7 Percentage of participants
|
32.7 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 44: Moderate (3)
|
—
|
28.0 Percentage of participants
|
30.8 Percentage of participants
|
25.9 Percentage of participants
|
26.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 44: Severe (4)
|
—
|
20.0 Percentage of participants
|
3.8 Percentage of participants
|
5.6 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 44: Very severe (5)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 48: Mild (2)
|
—
|
8.0 Percentage of participants
|
38.5 Percentage of participants
|
35.2 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week48: Moderate (3)
|
—
|
40.0 Percentage of participants
|
30.8 Percentage of participants
|
27.0 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 48: Severe (4)
|
—
|
16.0 Percentage of participants
|
3.8 Percentage of participants
|
5.6 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 20: Very severe (5)
|
—
|
4.0 Percentage of participants
|
7.7 Percentage of participants
|
0 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 48: Very severe (5)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 52: Clear (0)
|
—
|
4.0 Percentage of participants
|
3.8 Percentage of participants
|
7.4 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 52: Almost clear (1)
|
—
|
28.0 Percentage of participants
|
23.1 Percentage of participants
|
24.1 Percentage of participants
|
21.2 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 52: Mild (2)
|
—
|
20.0 Percentage of participants
|
50.0 Percentage of participants
|
40.7 Percentage of participants
|
51.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 52: Moderate (3)
|
—
|
32.0 Percentage of participants
|
19.2 Percentage of participants
|
24.1 Percentage of participants
|
21.2 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 52: Severe (4)
|
—
|
16.0 Percentage of participants
|
3.8 Percentage of participants
|
3.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 52: Very severe (5)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 60: Clear (0)
|
—
|
4.0 Percentage of participants
|
3.8 Percentage of participants
|
9.3 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 60: Almost clear (1)
|
—
|
20.0 Percentage of participants
|
23.1 Percentage of participants
|
25.9 Percentage of participants
|
44.2 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 60: Mild (2)
|
—
|
24.0 Percentage of participants
|
46.2 Percentage of participants
|
38.9 Percentage of participants
|
26.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 60: Moderate (3)
|
—
|
40.0 Percentage of participants
|
26.9 Percentage of participants
|
20.4 Percentage of participants
|
21.2 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 60: Severe (4)
|
—
|
12.0 Percentage of participants
|
0 Percentage of participants
|
5.6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 60: Very severe (5)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 72: Clear (0)
|
—
|
4.8 Percentage of participants
|
0 Percentage of participants
|
11.1 Percentage of participants
|
13.6 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 72: Almost clear (1)
|
—
|
19.0 Percentage of participants
|
37.5 Percentage of participants
|
28.9 Percentage of participants
|
38.6 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 72: Mild (2)
|
—
|
52.4 Percentage of participants
|
50.0 Percentage of participants
|
42.2 Percentage of participants
|
34.1 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 72: Moderate (3)
|
—
|
19.0 Percentage of participants
|
12.5 Percentage of participants
|
17.8 Percentage of participants
|
13.6 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 72: Severe (4)
|
—
|
4.8 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 72: Very severe (5)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 84: Clear (0)
|
—
|
4.8 Percentage of participants
|
0 Percentage of participants
|
4.4 Percentage of participants
|
16.3 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 84: Almost clear (1)
|
—
|
38.1 Percentage of participants
|
54.2 Percentage of participants
|
33.3 Percentage of participants
|
37.2 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 84: Moderate (3)
|
—
|
4.8 Percentage of participants
|
12.5 Percentage of participants
|
13.3 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 84: Severe (4)
|
—
|
14.3 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
2.3 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 84: Very severe (5)
|
—
|
0 Percentage of participants
|
4.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 2: Clear (0)
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 2: Almost clear (1)
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 2: Moderate (3)
|
39.6 Percentage of participants
|
—
|
—
|
46.3 Percentage of participants
|
44.2 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 2: Severe (4)
|
47.2 Percentage of participants
|
—
|
—
|
48.1 Percentage of participants
|
36.5 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 2: Very severe (5)
|
7.5 Percentage of participants
|
—
|
—
|
3.7 Percentage of participants
|
11.5 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 4: Clear (0)
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 4: Almost clear (1)
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 4: Mild (2)
|
7.5 Percentage of participants
|
—
|
—
|
5.6 Percentage of participants
|
9.6 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 4: Moderate (3)
|
39.6 Percentage of participants
|
—
|
—
|
53.7 Percentage of participants
|
38.5 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 4: Severe (4)
|
45.3 Percentage of participants
|
—
|
—
|
38.9 Percentage of participants
|
48.1 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 4: Very severe (5)
|
7.5 Percentage of participants
|
—
|
—
|
1.9 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 8: Clear (0)
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 8: Almost clear (1)
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 8: Mild (2)
|
15.1 Percentage of participants
|
—
|
—
|
18.5 Percentage of participants
|
11.5 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 8: Moderate (3)
|
37.7 Percentage of participants
|
—
|
—
|
61.1 Percentage of participants
|
48.1 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 8: Severe (4)
|
41.5 Percentage of participants
|
—
|
—
|
20.4 Percentage of participants
|
36.5 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 8: Very severe (5)
|
5.7 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 12: Clear (0)
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 12: Almost clear (1)
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 12: Mild (2)
|
17.0 Percentage of participants
|
—
|
—
|
31.5 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 12: Moderate (3)
|
43.4 Percentage of participants
|
—
|
—
|
48.1 Percentage of participants
|
44.2 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 12: Severe (4)
|
32.1 Percentage of participants
|
—
|
—
|
20.4 Percentage of participants
|
30.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 12: Very severe (5)
|
7.5 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 16: Clear (0)
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 16: Almost clear (1)
|
5.7 Percentage of participants
|
—
|
—
|
7.4 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 16: Mild (2)
|
15.1 Percentage of participants
|
—
|
—
|
38.9 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 16: Moderate (3)
|
43.4 Percentage of participants
|
—
|
—
|
44.4 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 16: Severe (4)
|
28.3 Percentage of participants
|
—
|
—
|
9.3 Percentage of participants
|
19.2 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 16: Very severe (5)
|
7.5 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 20: Clear (0)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 20: Almost clear (1)
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
9.3 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 20: Mild (2)
|
—
|
28.0 Percentage of participants
|
23.1 Percentage of participants
|
38.9 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 20: Moderate (3)
|
—
|
32.0 Percentage of participants
|
42.3 Percentage of participants
|
44.4 Percentage of participants
|
53.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 20: Severe (4)
|
—
|
28.0 Percentage of participants
|
23.1 Percentage of participants
|
7.4 Percentage of participants
|
9.6 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 24: Clear (0)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 24: Almost clear (1)
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
14.8 Percentage of participants
|
13.5 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 24: Mild (2)
|
—
|
36.0 Percentage of participants
|
42.3 Percentage of participants
|
40.7 Percentage of participants
|
42.7 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 24: Moderate (3)
|
—
|
36.0 Percentage of participants
|
26.9 Percentage of participants
|
37.0 Percentage of participants
|
42.3 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 24: Severe (4)
|
—
|
16.0 Percentage of participants
|
23.1 Percentage of participants
|
7.4 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 24: Very severe (5)
|
—
|
4.0 Percentage of participants
|
3.8 Percentage of participants
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 28: Clear (0)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 28: Almost clear (1)
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
14.8 Percentage of participants
|
13.5 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 28: Mild (2)
|
—
|
28.0 Percentage of participants
|
46.2 Percentage of participants
|
46.3 Percentage of participants
|
40.4 Percentage of participants
|
|
Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score
Week 28: Moderate (3)
|
—
|
48.0 Percentage of participants
|
23.1 Percentage of participants
|
33.3 Percentage of participants
|
38.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 2
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 4
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 8
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 12
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 16
|
5.7 Percentage of participants
|
—
|
—
|
7.4 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 20
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
9.3 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 24
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
14.8 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 28
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
14.8 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 32
|
—
|
8.0 Percentage of participants
|
11.5 Percentage of participants
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 36
|
—
|
12.0 Percentage of participants
|
19.2 Percentage of participants
|
22.2 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 40
|
—
|
20.0 Percentage of participants
|
23.1 Percentage of participants
|
24.1 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 44
|
—
|
28.0 Percentage of participants
|
15.4 Percentage of participants
|
27.8 Percentage of participants
|
34.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 48
|
—
|
36.0 Percentage of participants
|
26.9 Percentage of participants
|
31.5 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 52
|
—
|
32.0 Percentage of participants
|
26.9 Percentage of participants
|
31.5 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 60
|
—
|
24.0 Percentage of participants
|
26.9 Percentage of participants
|
35.2 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 72
|
—
|
23.8 Percentage of participants
|
37.5 Percentage of participants
|
40.0 Percentage of participants
|
52.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)
Week 84
|
—
|
42.9 Percentage of participants
|
54.2 Percentage of participants
|
37.8 Percentage of participants
|
53.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) and had at least a 2-grade improvement from baseline were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 44
|
—
|
28.0 Percentage of participants
|
15.4 Percentage of participants
|
27.8 Percentage of participants
|
34.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 2
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 48
|
—
|
36.0 Percentage of participants
|
26.9 Percentage of participants
|
31.5 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 4
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 8
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 12
|
0 Percentage of participants
|
—
|
—
|
0 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 16
|
5.7 Percentage of participants
|
—
|
—
|
7.4 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 20
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
9.3 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 24
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
14.8 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 28
|
—
|
8.0 Percentage of participants
|
3.8 Percentage of participants
|
14.8 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 32
|
—
|
8.0 Percentage of participants
|
11.5 Percentage of participants
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 36
|
—
|
12.0 Percentage of participants
|
19.2 Percentage of participants
|
22.2 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 40
|
—
|
20.0 Percentage of participants
|
23.1 Percentage of participants
|
24.1 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 52
|
—
|
32.0 Percentage of participants
|
26.9 Percentage of participants
|
31.5 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 60
|
—
|
24.0 Percentage of participants
|
26.9 Percentage of participants
|
35.2 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 72
|
—
|
23.8 Percentage of participants
|
37.5 Percentage of participants
|
40.0 Percentage of participants
|
52.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement
Week 84
|
—
|
42.9 Percentage of participants
|
54.2 Percentage of participants
|
37.8 Percentage of participants
|
53.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16, 32, 52, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a participant's QOL. It is a 10-item participant-reported outcome questionnaire that, in addition to evaluating overall QOL, can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. Higher score indicates more severe disease. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
Change at week 16
|
-1.8 Units on a scale
Standard Deviation 4.71
|
—
|
—
|
-5.0 Units on a scale
Standard Deviation 5.59
|
-3.1 Units on a scale
Standard Deviation 3.49
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
Change at week 32
|
—
|
-4.3 Units on a scale
Standard Deviation 5.25
|
-4.2 Units on a scale
Standard Deviation 5.09
|
-5.2 Units on a scale
Standard Deviation 5.90
|
-4.2 Units on a scale
Standard Deviation 4.18
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
Change at week 52
|
—
|
-4.8 Units on a scale
Standard Deviation 5.74
|
-5.2 Units on a scale
Standard Deviation 5.10
|
-5.7 Units on a scale
Standard Deviation 6.05
|
-4.9 Units on a scale
Standard Deviation 5.24
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
Change at week 72
|
—
|
-5.5 Units on a scale
Standard Deviation 5.82
|
-5.8 Units on a scale
Standard Deviation 4.28
|
-6.2 Units on a scale
Standard Deviation 5.78
|
-5.8 Units on a scale
Standard Deviation 5.20
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
Change at week 84
|
—
|
-6.0 Units on a scale
Standard Deviation 5.29
|
-5.6 Units on a scale
Standard Deviation 4.66
|
-6.4 Units on a scale
Standard Deviation 5.59
|
-6.3 Units on a scale
Standard Deviation 5.41
|
SECONDARY outcome
Timeframe: Baseline, Week 16, 32, 52, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score
Change at week 16
|
1.27 Units on a scale
Standard Deviation 9.177
|
—
|
—
|
4.67 Units on a scale
Standard Deviation 13.753
|
3.34 Units on a scale
Standard Deviation 10.259
|
|
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score
Change at week 32
|
—
|
5.46 Units on a scale
Standard Deviation 16.226
|
7.16 Units on a scale
Standard Deviation 11.507
|
8.31 Units on a scale
Standard Deviation 15.510
|
4.82 Units on a scale
Standard Deviation 9.975
|
|
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score
Change at week 52
|
—
|
7.92 Units on a scale
Standard Deviation 14.580
|
8.18 Units on a scale
Standard Deviation 11.320
|
7.35 Units on a scale
Standard Deviation 17.320
|
6.47 Units on a scale
Standard Deviation 11.466
|
|
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score
Change at week 72
|
—
|
9.02 Units on a scale
Standard Deviation 17.049
|
7.02 Units on a scale
Standard Deviation 11.806
|
6.75 Units on a scale
Standard Deviation 15.098
|
7.55 Units on a scale
Standard Deviation 11.453
|
|
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score
Change at week 84
|
—
|
9.29 Units on a scale
Standard Deviation 19.175
|
9.01 Units on a scale
Standard Deviation 12.964
|
7.06 Units on a scale
Standard Deviation 15.034
|
6.75 Units on a scale
Standard Deviation 13.619
|
SECONDARY outcome
Timeframe: Baseline, Week 16, 32, 52, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score
Change at week 84
|
—
|
1.72 Units on a scale
Standard Deviation 8.740
|
0.78 Units on a scale
Standard Deviation 6.975
|
2.51 Units on a scale
Standard Deviation 8.428
|
2.58 Units on a scale
Standard Deviation 7.977
|
|
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score
Change at week 16
|
1.20 Units on a scale
Standard Deviation 7.823
|
—
|
—
|
0.64 Units on a scale
Standard Deviation 7.880
|
0.66 Units on a scale
Standard Deviation 7.055
|
|
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score
Change at week 32
|
—
|
2.19 Units on a scale
Standard Deviation 10.277
|
1.10 Units on a scale
Standard Deviation 7.579
|
0.52 Units on a scale
Standard Deviation 8.124
|
0.59 Units on a scale
Standard Deviation 7.639
|
|
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score
Change at week 52
|
—
|
1.44 Units on a scale
Standard Deviation 9.980
|
0.39 Units on a scale
Standard Deviation 7.431
|
1.69 Units on a scale
Standard Deviation 7.866
|
0.69 Units on a scale
Standard Deviation 7.354
|
|
Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score
Change at week 72
|
—
|
1.51 Units on a scale
Standard Deviation 10.679
|
0.02 Units on a scale
Standard Deviation 8.686
|
2.19 Units on a scale
Standard Deviation 7.112
|
0.92 Units on a scale
Standard Deviation 6.797
|
SECONDARY outcome
Timeframe: Baseline, Week 16, 32, 52, 72 and Week 84Population: Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.
EQ-5D is designed for self-completion by participants and consists of EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and unable. The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion their baseline value carried forward to the post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Outcome measures
| Measure |
Placebo
n=53 Participants
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.
|
Guselkumab 100 mg
n=25 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=26 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 Participants
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 Participants
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score
Change at week 16
|
-0.1 Units on a scale
Standard Deviation 14.33
|
—
|
—
|
8.3 Units on a scale
Standard Deviation 21.25
|
8.5 Units on a scale
Standard Deviation 15.59
|
|
Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score
Change at week 32
|
—
|
8.0 Units on a scale
Standard Deviation 25.36
|
6.5 Units on a scale
Standard Deviation 15.75
|
10.2 Units on a scale
Standard Deviation 21.88
|
5.9 Units on a scale
Standard Deviation 15.98
|
|
Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score
Change at week 52
|
—
|
13.0 Units on a scale
Standard Deviation 24.69
|
5.6 Units on a scale
Standard Deviation 16.28
|
13.9 Units on a scale
Standard Deviation 22.19
|
7.9 Units on a scale
Standard Deviation 15.19
|
|
Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score
Change at week 72
|
—
|
13.0 Units on a scale
Standard Deviation 21.59
|
8.7 Units on a scale
Standard Deviation 21.08
|
12.9 Units on a scale
Standard Deviation 22.43
|
10.5 Units on a scale
Standard Deviation 17.11
|
|
Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score
Change at week 84
|
—
|
6.7 Units on a scale
Standard Deviation 24.71
|
10.0 Units on a scale
Standard Deviation 19.55
|
10.5 Units on a scale
Standard Deviation 21.53
|
8.7 Units on a scale
Standard Deviation 18.42
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo Then Guselkumab 100 mg
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo Then Guselkumab 200 mg
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Guselkumab 100 mg
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Guselkumab 200 mg
Serious events: 5 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=53 participants at risk
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.
|
Placebo Then Guselkumab 100 mg
n=25 participants at risk
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 Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Placebo Then Guselkumab 200 mg
n=26 participants at risk
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 Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 participants at risk
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 participants at risk
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Heat Stroke
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Synovial Rupture
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Carcinoma Cell Type Unspecified Stage 0
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Surgical and medical procedures
Abortion Induced
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Surgical and medical procedures
Medical Device Removal
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
Other adverse events
| Measure |
Placebo
n=53 participants at risk
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.
|
Placebo Then Guselkumab 100 mg
n=25 participants at risk
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 Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Placebo Then Guselkumab 200 mg
n=26 participants at risk
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 Week 16 and 20 and every 8 Weeks thereafter through Week 60. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
Guselkumab 100 mg
n=54 participants at risk
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. All participants who continued the study at Week 60 in this group were observed from until Week 84 without receiving the study drug.
|
Guselkumab 200 mg
n=52 participants at risk
Participants received guselkumab 200 mg SC injection at Weeks 0, 4, and 12 and thereafter once every 8 Weeks through Week 60 and placebo matched to guselkumab SC injection at Week 16 to maintain the blind. All participants who continued the study at Week 60 in this group were observed until Week 84 without receiving the study drug.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Ear and labyrinth disorders
Deafness Neurosensory
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Eye disorders
Corneal Perforation
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
7.4%
4/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Dental Caries
|
3.8%
2/53 • Baseline (Week 0) up to Week 84
|
8.0%
2/25 • Baseline (Week 0) up to Week 84
|
11.5%
3/26 • Baseline (Week 0) up to Week 84
|
7.4%
4/54 • Baseline (Week 0) up to Week 84
|
7.7%
4/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
7.4%
4/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
7.7%
2/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
General disorders
Fatigue
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
General disorders
Injection Site Erythema
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
12.0%
3/25 • Baseline (Week 0) up to Week 84
|
19.2%
5/26 • Baseline (Week 0) up to Week 84
|
7.4%
4/54 • Baseline (Week 0) up to Week 84
|
19.2%
10/52 • Baseline (Week 0) up to Week 84
|
|
General disorders
Injection Site Induration
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
General disorders
Injection Site Pruritus
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
8.0%
2/25 • Baseline (Week 0) up to Week 84
|
11.5%
3/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
9.6%
5/52 • Baseline (Week 0) up to Week 84
|
|
General disorders
Injection Site Swelling
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
11.5%
3/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
5.8%
3/52 • Baseline (Week 0) up to Week 84
|
|
General disorders
Malaise
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Bronchitis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Cystitis
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
8.0%
2/25 • Baseline (Week 0) up to Week 84
|
7.7%
2/26 • Baseline (Week 0) up to Week 84
|
5.6%
3/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Folliculitis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
5.6%
3/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
5.8%
3/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Gingivitis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
7.7%
2/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Herpes Simplex
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Influenza
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Nasopharyngitis
|
17.0%
9/53 • Baseline (Week 0) up to Week 84
|
68.0%
17/25 • Baseline (Week 0) up to Week 84
|
53.8%
14/26 • Baseline (Week 0) up to Week 84
|
37.0%
20/54 • Baseline (Week 0) up to Week 84
|
48.1%
25/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Oral Herpes
|
3.8%
2/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
11.5%
3/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
5.8%
3/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Tinea Pedis
|
3.8%
2/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
9.3%
5/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
5.6%
3/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
7.7%
2/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
3.8%
2/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Traumatic Ulcer
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
3.8%
2/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
12.0%
3/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
3/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
7.4%
4/54 • Baseline (Week 0) up to Week 84
|
9.6%
5/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.8%
2/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
5.6%
3/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
8.0%
2/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
5.8%
3/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
7.7%
2/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Peripheral Arthritis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Nervous system disorders
Headache
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
5.6%
3/54 • Baseline (Week 0) up to Week 84
|
7.7%
4/52 • Baseline (Week 0) up to Week 84
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Nervous system disorders
Somnolence
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Chronic Pigmented Purpura
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.8%
2/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
3.8%
2/53 • Baseline (Week 0) up to Week 84
|
8.0%
2/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
7.4%
4/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.7%
3/53 • Baseline (Week 0) up to Week 84
|
12.0%
3/25 • Baseline (Week 0) up to Week 84
|
7.7%
2/26 • Baseline (Week 0) up to Week 84
|
11.1%
6/54 • Baseline (Week 0) up to Week 84
|
15.4%
8/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Eczema Asteatotic
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
7.7%
4/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Eczema Nummular
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
5.8%
3/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
5.8%
3/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Polymorphic Light Eruption
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
5.8%
3/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Pustular Psoriasis
|
7.5%
4/53 • Baseline (Week 0) up to Week 84
|
8.0%
2/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
7.4%
4/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
5.8%
3/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Skin Discomfort
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
8.0%
2/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
13.5%
7/52 • Baseline (Week 0) up to Week 84
|
|
Vascular disorders
Hypertension
|
3.8%
2/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/24 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Gastrointestinal disorders
Oral Lichen Planus
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
General disorders
Pyrexia
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/24 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
4.8%
2/42 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Furuncle
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Helicobacter Gastritis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Infected Dermal Cyst
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Myringitis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Infections and infestations
Periodontitis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
7.7%
2/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
3.8%
2/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
8.0%
2/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
3.7%
2/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
1.9%
1/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Nervous system disorders
Sciatica
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/53 • Baseline (Week 0) up to Week 84
|
0.00%
0/25 • Baseline (Week 0) up to Week 84
|
3.8%
1/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
1.9%
1/52 • Baseline (Week 0) up to Week 84
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
1.9%
1/53 • Baseline (Week 0) up to Week 84
|
4.0%
1/25 • Baseline (Week 0) up to Week 84
|
0.00%
0/26 • Baseline (Week 0) up to Week 84
|
0.00%
0/54 • Baseline (Week 0) up to Week 84
|
0.00%
0/52 • Baseline (Week 0) up to Week 84
|
Additional Information
Senior Director, Immunology General
Janssen Pharmaceutical K.K.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER