Trial Outcomes & Findings for Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis (NCT NCT02905331)
NCT ID: NCT02905331
Last Updated: 2025-02-04
Results Overview
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. Participants who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during study that could improve psoriasis were considered as treatment failures for the study.
COMPLETED
PHASE3
78 participants
Week 16
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. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
Placebo to Guselkumab
Participants who received placebo during placebo controlled period was crossed over to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28.
|
|---|---|---|---|
|
Placebo Controlled Period(Week[wk] 0-16)
STARTED
|
16
|
62
|
0
|
|
Placebo Controlled Period(Week[wk] 0-16)
COMPLETED
|
13
|
61
|
0
|
|
Placebo Controlled Period(Week[wk] 0-16)
NOT COMPLETED
|
3
|
1
|
0
|
|
Active Treatment and Follow up (wk16-40)
STARTED
|
0
|
61
|
13
|
|
Active Treatment and Follow up (wk16-40)
COMPLETED
|
0
|
53
|
13
|
|
Active Treatment and Follow up (wk16-40)
NOT COMPLETED
|
0
|
8
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
Placebo to Guselkumab
Participants who received placebo during placebo controlled period was crossed over to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28.
|
|---|---|---|---|
|
Placebo Controlled Period(Week[wk] 0-16)
Adverse Event
|
1
|
0
|
0
|
|
Placebo Controlled Period(Week[wk] 0-16)
Lack of Efficacy
|
2
|
0
|
0
|
|
Placebo Controlled Period(Week[wk] 0-16)
Lost to Follow-up
|
0
|
1
|
0
|
|
Active Treatment and Follow up (wk16-40)
Other
|
0
|
6
|
0
|
|
Active Treatment and Follow up (wk16-40)
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
n=62 Participants
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 12.92 • n=7 Participants
|
46 years
STANDARD_DEVIATION 13.43 • n=5 Participants
|
|
Age, Customized
>=18 to 65 years
|
14 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
13 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
5 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Full analysis set (FAS) included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. Participants who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during study that could improve psoriasis were considered as treatment failures for the study.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
n=62 Participants
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
|---|---|---|
|
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
|
0 Percentage of participants
|
80.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent (%) to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
n=62 Participants
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
|
0 Percentage of participants
|
75.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) were considered IGA cleared responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
n=62 Participants
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
|---|---|---|
|
Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16
|
0 Percentage of participants
|
56.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with 100% improvement in PASI from baseline (PASI score=0) were considered PASI 100 responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
n=62 Participants
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
|---|---|---|
|
Percentage of Participants Who Achieve a PASI 100 Response at Week 16
|
0 Percentage of participants
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
n=62 Participants
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
|---|---|---|
|
Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16
|
0 Percentage of participants
|
93.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with \>=50% and \>= 75% improvement in PASI from baseline were considered PASI 50 and PASI 75 responders respectively. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
n=62 Participants
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
|---|---|---|
|
Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16
PASI 50 responders
|
0 Percentage of participants
|
93.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16
PASI 75 responders
|
0 Percentage of participants
|
88.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS included all randomized participants who received at least 1 injection of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Imputation was applied only for participants who met treatment failure and their missing values were counted as zero.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
n=61 Participants
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
|---|---|---|
|
Percent Improvement From Baseline in PASI Score at Week 16
|
8.72 Percent improvement
Standard Deviation 18.229
|
91.53 Percent improvement
Standard Deviation 16.756
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended every 8 weeks [q8w] dosing interval)Population: FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Imputation was applied only for participants who met treatment failure and their missing values were counted as zero.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
n=62 Participants
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
|---|---|---|
|
Percent Improvement From Baseline in PASI Score Through Week 40
Week 4
|
5.58 Percent improvement
Standard Deviation 13.970
|
40.99 Percent improvement
Standard Deviation 26.377
|
|
Percent Improvement From Baseline in PASI Score Through Week 40
Week 8
|
10.45 Percent improvement
Standard Deviation 21.540
|
71.76 Percent improvement
Standard Deviation 26.984
|
|
Percent Improvement From Baseline in PASI Score Through Week 40
Week 32
|
96.16 Percent improvement
Standard Deviation 5.602
|
96.64 Percent improvement
Standard Deviation 7.143
|
|
Percent Improvement From Baseline in PASI Score Through Week 40
Week 12
|
13.76 Percent improvement
Standard Deviation 24.143
|
84.97 Percent improvement
Standard Deviation 20.520
|
|
Percent Improvement From Baseline in PASI Score Through Week 40
Week 20
|
62.65 Percent improvement
Standard Deviation 20.760
|
94.77 Percent improvement
Standard Deviation 13.179
|
|
Percent Improvement From Baseline in PASI Score Through Week 40
Week 24
|
88.74 Percent improvement
Standard Deviation 12.092
|
95.89 Percent improvement
Standard Deviation 10.164
|
|
Percent Improvement From Baseline in PASI Score Through Week 40
Week 28
|
95.68 Percent improvement
Standard Deviation 6.162
|
96.30 Percent improvement
Standard Deviation 7.504
|
|
Percent Improvement From Baseline in PASI Score Through Week 40
Week 40
|
97.70 Percent improvement
Standard Deviation 3.443
|
92.47 Percent improvement
Standard Deviation 13.289
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)Population: FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Non-responder imputation was used to impute missing data.
The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders while those achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
n=62 Participants
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
|---|---|---|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 8: IGA of cleared (0)
|
0 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 20: IGA of cleared (0)
|
0 Percentage of participants
|
67.7 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 4: IGA of cleared (0)
|
0 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 4: IGA of cleared (0) or minimal (1)
|
0 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 4: IGA of mild or better (<=2)
|
0 Percentage of participants
|
54.8 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 8: IGA of cleared (0) or minimal (1)
|
0 Percentage of participants
|
56.5 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 8: IGA of mild or better (<=2)
|
12.5 Percentage of participants
|
85.5 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 12: IGA of cleared (0)
|
0 Percentage of participants
|
35.5 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 12: IGA of cleared (0) or minimal (1)
|
0 Percentage of participants
|
67.7 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 12: IGA of mild or better (<=2)
|
0 Percentage of participants
|
91.9 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 20: IGA of cleared (0) or minimal (1)
|
46.2 Percentage of participants
|
85.5 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 20: IGA of mild or better (<=2)
|
92.3 Percentage of participants
|
93.5 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 24: IGA of cleared (0)
|
38.5 Percentage of participants
|
71.0 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 24: IGA of cleared (0) or minimal (1)
|
100.0 Percentage of participants
|
87.1 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 24: IGA of mild or better (<=2)
|
100.0 Percentage of participants
|
88.7 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 28: IGA of cleared (0)
|
61.5 Percentage of participants
|
64.5 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 28: IGA of cleared (0) or minimal (1)
|
100.0 Percentage of participants
|
87.1 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 28: IGA of mild or better (<=2)
|
100.0 Percentage of participants
|
95.2 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 32: IGA of cleared (0)
|
69.2 Percentage of participants
|
66.1 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 32: IGA of cleared (0) or minimal (1)
|
92.3 Percentage of participants
|
82.3 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 32: IGA of mild or better (<=2)
|
100.0 Percentage of participants
|
90.3 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 40: IGA of cleared (0)
|
61.5 Percentage of participants
|
53.2 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 40: IGA of cleared (0) or minimal (1)
|
92.3 Percentage of participants
|
71.0 Percentage of participants
|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Week 40:IGA of mild or better (<=2)
|
100.0 Percentage of participants
|
79.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)Population: FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Non-responder imputation was used to impute missing data.
PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with \>=50%, \>= 75%, \>=90% and \>= 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab
n=62 Participants
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
|---|---|---|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 12: >= 90% improvement
|
0 Percentage of participants
|
54.8 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 20: >=75% improvement
|
30.8 Percentage of participants
|
91.9 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 28: >=90% improvement
|
84.6 Percentage of participants
|
85.5 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 40: >=75% improvement
|
100.0 Percentage of participants
|
79.0 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 4: 100% improvement
|
0 Percentage of participants
|
3.2 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 4: >= 90% improvement
|
0 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 4: >= 75% improvement
|
0 Percentage of participants
|
12.9 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 4: >= 50% improvement
|
0 Percentage of participants
|
33.9 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 8: 100% improvement
|
0 Percentage of participants
|
16.1 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 8: >= 90% improvement
|
0 Percentage of participants
|
33.9 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 8: >= 75% improvement
|
0 Percentage of participants
|
56.5 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 8: >= 50% improvement
|
6.3 Percentage of participants
|
80.6 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 12: 100% improvement
|
0 Percentage of participants
|
30.6 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 12: >= 75% improvement
|
0 Percentage of participants
|
77.4 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 12: >= 50% improvement
|
12.5 Percentage of participants
|
90.3 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 16: 100% improvement
|
0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 16: >=90% improvement
|
0 Percentage of participants
|
75.8 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 16: >=75% improvement
|
0 Percentage of participants
|
88.7 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 16: >=50% improvement
|
0 Percentage of participants
|
93.5 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 20: 100% improvement
|
0 Percentage of participants
|
66.1 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 20: >=90% improvement
|
7.7 Percentage of participants
|
85.5 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 20: >=50% improvement
|
69.2 Percentage of participants
|
95.2 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 24: 100% improvement
|
30.8 Percentage of participants
|
71.0 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 24: >=90% improvement
|
61.5 Percentage of participants
|
82.3 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 24: >=75% improvement
|
84.6 Percentage of participants
|
88.7 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 24: >=50% improvement
|
100.0 Percentage of participants
|
95.2 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 28: 100% improvement
|
53.8 Percentage of participants
|
64.5 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 28: >=75% improvement
|
100.0 Percentage of participants
|
95.2 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 28: >50% improvement
|
100.0 Percentage of participants
|
96.8 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 32: 100% improvement
|
61.5 Percentage of participants
|
64.5 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 32: >=90% improvement
|
84.6 Percentage of participants
|
85.5 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 32: >=75% improvement
|
100.0 Percentage of participants
|
90.3 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 32: >=50% improvement
|
100.0 Percentage of participants
|
93.5 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 40: 100% improvement
|
53.8 Percentage of participants
|
53.2 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 40: >=90% improvement
|
100.0 Percentage of participants
|
66.1 Percentage of participants
|
|
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Week 40: >=50% improvement
|
100.0 Percentage of participants
|
79.0 Percentage of participants
|
Adverse Events
Placebo (Week 0-16)
Guselkumab (Week 0-16)
Placebo to Guselkumab (Week 16-40)
Guselkumab (Week 16-40)
Serious adverse events
| Measure |
Placebo (Week 0-16)
n=16 participants at risk
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab (Week 0-16)
n=62 participants at risk
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
Placebo to Guselkumab (Week 16-40)
n=13 participants at risk
Participants who received placebo during placebo controlled period was crossed over to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28.
|
Guselkumab (Week 16-40)
n=61 participants at risk
Participants received placebo at Week 16, and 100 mg guselkumab at Week 20 and 28.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
General disorders
Chest Discomfort
|
0.00%
0/16 • Up to Week 40
|
1.6%
1/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
General disorders
Chest Pain
|
0.00%
0/16 • Up to Week 40
|
1.6%
1/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
1.6%
1/61 • Up to Week 40
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
Other adverse events
| Measure |
Placebo (Week 0-16)
n=16 participants at risk
Participants received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period. At Week 16 participants were crossed over to receive guselkumab 100 milligram (mg) at weeks 16, 20, and 28.
|
Guselkumab (Week 0-16)
n=62 participants at risk
Participants received guselkumab 100 mg SC injection at weeks 0, 4, 12, 20 and 28. Participants received placebo at Week 16 to maintain the study blind.
|
Placebo to Guselkumab (Week 16-40)
n=13 participants at risk
Participants who received placebo during placebo controlled period was crossed over to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28.
|
Guselkumab (Week 16-40)
n=61 participants at risk
Participants received placebo at Week 16, and 100 mg guselkumab at Week 20 and 28.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
1.6%
1/61 • Up to Week 40
|
|
Cardiac disorders
Left Ventricular Hypertrophy
|
0.00%
0/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
6.2%
1/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
General disorders
Injection Site Bruising
|
6.2%
1/16 • Up to Week 40
|
3.2%
2/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
1.6%
1/61 • Up to Week 40
|
|
General disorders
Injection Site Coldness
|
18.8%
3/16 • Up to Week 40
|
22.6%
14/62 • Up to Week 40
|
15.4%
2/13 • Up to Week 40
|
11.5%
7/61 • Up to Week 40
|
|
General disorders
Injection Site Erythema
|
6.2%
1/16 • Up to Week 40
|
11.3%
7/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
6.6%
4/61 • Up to Week 40
|
|
General disorders
Injection Site Induration
|
12.5%
2/16 • Up to Week 40
|
11.3%
7/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
3.3%
2/61 • Up to Week 40
|
|
General disorders
Injection Site Oedema
|
6.2%
1/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
General disorders
Injection Site Pain
|
43.8%
7/16 • Up to Week 40
|
40.3%
25/62 • Up to Week 40
|
23.1%
3/13 • Up to Week 40
|
18.0%
11/61 • Up to Week 40
|
|
General disorders
Injection Site Pruritus
|
12.5%
2/16 • Up to Week 40
|
12.9%
8/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
3.3%
2/61 • Up to Week 40
|
|
General disorders
Injection Site Swelling
|
6.2%
1/16 • Up to Week 40
|
11.3%
7/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
4.9%
3/61 • Up to Week 40
|
|
Infections and infestations
Furuncle
|
0.00%
0/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Infections and infestations
Tooth Abscess
|
6.2%
1/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Infections and infestations
Tooth Infection
|
6.2%
1/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
3.3%
2/61 • Up to Week 40
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/16 • Up to Week 40
|
8.1%
5/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
1.6%
1/61 • Up to Week 40
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/16 • Up to Week 40
|
4.8%
3/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
9.8%
6/61 • Up to Week 40
|
|
Investigations
Hepatic Enzyme Increased
|
6.2%
1/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
1.6%
1/61 • Up to Week 40
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
6.2%
1/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Up to Week 40
|
1.6%
1/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
6.2%
1/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Reproductive system and breast disorders
Vaginal Cyst
|
6.2%
1/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
0.00%
0/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Skin and subcutaneous tissue disorders
Urticaria Pressure
|
0.00%
0/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Up to Week 40
|
0.00%
0/62 • Up to Week 40
|
7.7%
1/13 • Up to Week 40
|
0.00%
0/61 • Up to Week 40
|
Additional Information
Senior Director, Immunology General
Janssen Research & Development, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER