Trial Outcomes & Findings for A Study of Guselkumab in Participants With Systemic Sclerosis (NCT NCT04683029)
NCT ID: NCT04683029
Last Updated: 2025-07-23
Results Overview
Change from baseline in mRSS at Week 24 was reported. The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the thickening of the skin using the mRSS through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (no thickening) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2025-07-23
Participant Flow
Participants diagnosed with systemic sclerosis as per American College of Rheumatology and European League Against Rheumatism 2013 criteria with disease duration of less than or equal to (\<=) 36 months and Modified Rodnan Skin Score ranged from greater than or equal to (\>=) 10 to less than or equal to (\<=) 22 units were randomized into the study.
Participant milestones
| Measure |
Main Study: Group A: Guselkumab
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
LTE Period: Group A: Guselkumab Then Guselkumab
Participants who received guselkumab and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 200 mg SC injection and placebo IV infusion at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112.
|
LTE Period: Group B: Placebo Then Guselkumab
Participants who received placebo and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 400 mg IV infusion and placebo SC injection at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112.
|
|---|---|---|---|---|
|
Main Study: Week 0-Week 60
STARTED
|
29
|
27
|
0
|
0
|
|
Main Study: Week 0-Week 60
COMPLETED
|
28
|
27
|
0
|
0
|
|
Main Study: Week 0-Week 60
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Long-term Extension(LTE):Week52-Week 112
STARTED
|
0
|
0
|
25
|
26
|
|
Long-term Extension(LTE):Week52-Week 112
COMPLETED
|
0
|
0
|
24
|
24
|
|
Long-term Extension(LTE):Week52-Week 112
NOT COMPLETED
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Main Study: Group A: Guselkumab
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
LTE Period: Group A: Guselkumab Then Guselkumab
Participants who received guselkumab and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 200 mg SC injection and placebo IV infusion at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112.
|
LTE Period: Group B: Placebo Then Guselkumab
Participants who received placebo and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 400 mg IV infusion and placebo SC injection at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112.
|
|---|---|---|---|---|
|
Main Study: Week 0-Week 60
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Long-term Extension(LTE):Week52-Week 112
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
|
Long-term Extension(LTE):Week52-Week 112
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Guselkumab in Participants With Systemic Sclerosis
Baseline characteristics by cohort
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 Years
STANDARD_DEVIATION 13.26 • n=5 Participants
|
50.8 Years
STANDARD_DEVIATION 12.18 • n=7 Participants
|
51.1 Years
STANDARD_DEVIATION 12.64 • n=5 Participants
|
|
Age, Customized
18 to 64 years
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Customized
65 years and over
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 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
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
JAPAN
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The full analysis set (FAS) included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
Change from baseline in mRSS at Week 24 was reported. The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the thickening of the skin using the mRSS through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (no thickening) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24
|
-9.5 Score on a scale
Standard Error 0.74
|
3.1 Score on a scale
Standard Error 0.77
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
Change from baseline in mRSS at Week 52 was reported. The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the thickening of the skin using the mRSS through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (no thickening) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Change From Baseline in Modified Rodnan Skin Score at Week 52
|
-9.3 Score on a scale
Standard Error 0.89
|
2.7 Score on a scale
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
The percentage of participants who experienced worsening of mRSS at Week 24 and Week 52 was reported. The worsening of mRSS was defined as an increase from baseline greater than or equal to (\>=) 5 points and \>=20 percent (%) in mRSS. The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the thickening of the skin using the mRSS through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (no thickening) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Percentage of Participants Who Experienced Worsening of Modified Rodnan Skin Score at Week 24 and Week 52
Week 24
|
3.4 Percentage of participants
|
25.9 Percentage of participants
|
|
Main Study: Percentage of Participants Who Experienced Worsening of Modified Rodnan Skin Score at Week 24 and Week 52
Week 52
|
20.7 Percentage of participants
|
77.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
ACR CRISS is a composite endpoint. Firstly, participants were evaluated on not-improved criterion: new onset of renal crisis, \>=15% decline in forced vital capacity \[FVC\] percent predicted relative to baseline, new onset of pulmonary arterial hypertension, and new onset of left ventricular failure. If yes, these participants were assigned probability score of 0.0. For remaining participants, percentage was based on CRISS domains: mRSS, FVC percent predicted, physician's global assessment, patient's global assessment and Health Assessment Questionnaire Disability-Index (HAQ-DI). Algorithm determines predicted probability of improvement from baseline by incorporating change in mRSS, FVC percent predicted, physician and patient global assessments and HAQ-DI. Outcome was a continuous variable between 0.0 and 1.0 (0 to 100%). Higher score=greater probability of improvement. ACR CRISS score \>=0.60 was considered improved, while predicted probability below 0.60 was considered not improved.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Percentage of Participants Who Achieved a Score of 0.6 in American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) at Week 24 and Week 52
Week 24
|
86.2 Percentage of participants
|
3.7 Percentage of participants
|
|
Main Study: Percentage of Participants Who Achieved a Score of 0.6 in American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) at Week 24 and Week 52
Week 52
|
79.3 Percentage of participants
|
3.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 52Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
FVC was the total amount of air (in liters) exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying interstitial lung disease.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Change From Baseline in Forced Vital Capacity (FVC) at Week 24 and Week 52
Week 24
|
-51.9 Liters
Standard Error 33.91
|
-4.7 Liters
Standard Error 35.78
|
|
Main Study: Change From Baseline in Forced Vital Capacity (FVC) at Week 24 and Week 52
Week 52
|
-26.5 Liters
Standard Error 30.42
|
-12.3 Liters
Standard Error 32.15
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 52Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
Change from baseline in the percent predicted FVC at Week 24 and Week 52 was reported. FVC was the total amount of air (in liters) exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying interstitial lung disease.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 and Week 52
Week 24
|
-0.7 Percent predicted FVC
Standard Error 1.21
|
-0.7 Percent predicted FVC
Standard Error 1.26
|
|
Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 and Week 52
Week 52
|
-0.2 Percent predicted FVC
Standard Error 1.17
|
-0.4 Percent predicted FVC
Standard Error 1.22
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 52Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. DLCO is measured using the single breath method. Participants breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participants hold their breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Change From Baseline in the Measured Absolute Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52
Week 24
|
-0.60 Milliliter/minute/millimeter mercury
Standard Error 0.257
|
-0.51 Milliliter/minute/millimeter mercury
Standard Error 0.265
|
|
Main Study: Change From Baseline in the Measured Absolute Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52
Week 52
|
-0.35 Milliliter/minute/millimeter mercury
Standard Error 0.316
|
-0.56 Milliliter/minute/millimeter mercury
Standard Error 0.327
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 52Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
Change from baseline in the percent predicted DLCO at Week 24 and Week 52 was reported. DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. DLCO is measured using the single breath method. Participants breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participants hold their breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Change From Baseline in the Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52
Week 24
|
-4.57 Percent predicted DLCO
Standard Error 1.338
|
-2.49 Percent predicted DLCO
Standard Error 1.347
|
|
Main Study: Change From Baseline in the Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52
Week 52
|
-1.71 Percent predicted DLCO
Standard Error 1.541
|
-1.85 Percent predicted DLCO
Standard Error 1.565
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 52Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
Digital ulcers were defined as a full thickness (\>3 millimeters \[mm\] in maximal diameter) skin lesion with loss of epithelium including lesions covered by eschar (excluding pitting scars and hyperkeratotic lesions). Healing was defined by re-epithelialization with loss of pain and exudate. The digital ulcer assessments and counting were performed by the investigator designee.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 52
Week 52
|
-0.1 Ulcers
Standard Error 0.55
|
4.1 Ulcers
Standard Error 0.58
|
|
Main Study: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 52
Week 24
|
-0.0 Ulcers
Standard Error 0.47
|
4.8 Ulcers
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Baseline, Week 24 and Week 52Population: The FAS included all randomized participants who received at least 1 dose (complete or partial) of study intervention.
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during past week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each activity category consisted of 2-3 items. For each item, level of difficulty was scored from 0 to 3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Total HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 52
Week 24
|
-0.0529 Score on a scale
Standard Error 0.09062
|
0.3477 Score on a scale
Standard Error 0.09439
|
|
Main Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 52
Week 52
|
-0.0572 Score on a scale
Standard Error 0.08955
|
0.1782 Score on a scale
Standard Error 0.09321
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) up to Week 24 and Week 52Population: The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention. Participants were analyzed based on the intervention they received, regardless of the intervention groups to which they were assigned.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs that occur at or after the initial administration of study intervention. All TEAEs including serious and non-serious events are reported in this outcome measure.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 24 and Week 52
Week 24
|
20 Participants
|
24 Participants
|
|
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 24 and Week 52
Week 52
|
25 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: From Week 52 up to Week 112Population: The safety analysis set for LTE period included all randomized participants who received at least 1 dose (complete or partial) of study intervention during LTE period.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs that occurred at or after the initial administration of study intervention. All TEAEs including serious and non-serious events are reported in this outcome measure.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=25 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=26 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
23 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) up to Week 24 and Week 52Population: The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention. Participants were analyzed based on the intervention they received, regardless of the intervention groups to which they were assigned.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, or resulted in congenital anomaly/birth defect. TEAEs were defined as AEs that occur at or after the initial administration of study intervention.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 24 and Week 52
Week 24
|
0 Participants
|
0 Participants
|
|
Main Study: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 24 and Week 52
Week 52
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Week 52 up to Week 112Population: The safety analysis set for LTE period included all randomized participants who received at least 1 dose (complete or partial) of study intervention during LTE period.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, or resulted in congenital anomaly/birth defect. TEAEs were defined as AEs that occur at or after the initial administration of study intervention.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=25 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=26 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) up to Week 24 and Week 52Population: The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention. Participants were analyzed based on the intervention they received, regardless of the intervention groups to which they were assigned.
AESI were defined as any newly identified malignancy or case of active tuberculosis (TB) or interstitial lung disease (ILD) occurring after the first study intervention administration in study participants and was reported by the investigator to the sponsor or designee within 24 hours after being made aware of the event. AESIs for this study included drug-induced liver injuries, active TB, ILD, hypersensitivity reaction, opportunistic infection and adverse cardiovascular events.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Number of Participants With Adverse Events of Special Interest (AESI) Through Week 24 and Week 52
Week 24
|
0 Participants
|
0 Participants
|
|
Main Study: Number of Participants With Adverse Events of Special Interest (AESI) Through Week 24 and Week 52
Week 52
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Week 52 up to Week 112Population: The safety analysis set for LTE period included all randomized participants who received at least 1 dose (complete or partial) of study intervention during LTE period.
AESI were defined as any newly identified malignancy or case of active tuberculosis (TB) or interstitial lung disease (ILD) occurring after the first study intervention administration in study participants and was reported by the investigator to the sponsor or designee within 24 hours after being made aware of the event. AESIs for this study included drug-induced liver injuries, active TB, ILD, hypersensitivity reaction, opportunistic infection and adverse cardiovascular events.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=25 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=26 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Long-term Extension (LTE) Period: Number of Participants With Adverse Events of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Post- dose at Weeks 0, 4, 8Population: Pharmacokinetics analysis set included all participants who received at least 1 complete administration of guselkumab and had at least 1 observed post dose PK data. Here, 'n' (number analyzed) refers to participants evaluable at specified time points. This outcome measure was planned to be analyzed for specified arm only.
Serum concentration of guselkumab was reported. The lower limit of quantification (LLOQ) for guselkumab was 0.01 micrograms per milliliter (mcg/mL).
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 0
|
NA mcg/mL
Standard Deviation NA
Since concentration was below LLOQ, hence mean and standard deviation could not be calculated.
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Post-dose at Week 0
|
140.880 mcg/mL
Standard Deviation 26.5879
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 4
|
22.489 mcg/mL
Standard Deviation 6.9499
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Post-dose at Week 4
|
160.691 mcg/mL
Standard Deviation 31.7578
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 8
|
27.968 mcg/mL
Standard Deviation 9.7988
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Post-dose at Week 8
|
164.633 mcg/mL
Standard Deviation 28.9999
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 12
|
36.497 mcg/mL
Standard Deviation 13.7929
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 16
|
21.697 mcg/mL
Standard Deviation 9.6355
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 20
|
12.751 mcg/mL
Standard Deviation 6.0638
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 24
|
13.981 mcg/mL
Standard Deviation 6.6055
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 28
|
14.184 mcg/mL
Standard Deviation 5.6980
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 32
|
12.564 mcg/mL
Standard Deviation 5.6367
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 36
|
12.932 mcg/mL
Standard Deviation 6.4345
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 40
|
13.375 mcg/mL
Standard Deviation 6.1989
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 44
|
12.469 mcg/mL
Standard Deviation 6.8698
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 48
|
12.074 mcg/mL
Standard Deviation 6.1027
|
—
|
|
Main Study: Serum Concentration of Guselkumab
Pre-dose at Week 52
|
11.363 mcg/mL
Standard Deviation 6.6822
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (at Weeks 56, 60, 64, 76, 88, 96) and Week 104Population: Pharmacokinetics analysis set included all participants who received at least 1 complete administration of guselkumab and had at least 1 observed post dose PK data. Here, 'n' (number analyzed) refers to participants analyzed at specified time points.
Serum concentration of guselkumab was reported. The LLOQ for guselkumab was 0.01 mcg/mL.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=25 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=26 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab
Pre-dose at Week 56
|
12.167 mcg/mL
Standard Deviation 5.4753
|
19.285 mcg/mL
Standard Deviation 8.3377
|
|
Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab
Pre-dose at Week 60
|
12.704 mcg/mL
Standard Deviation 5.6942
|
25.925 mcg/mL
Standard Deviation 10.9856
|
|
Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab
Pre-dose at Week 64
|
13.835 mcg/mL
Standard Deviation 7.3326
|
33.368 mcg/mL
Standard Deviation 14.8075
|
|
Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab
Pre-dose at Week 76
|
11.641 mcg/mL
Standard Deviation 5.5746
|
13.200 mcg/mL
Standard Deviation 6.0810
|
|
Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab
Pre-dose at Week 88
|
10.339 mcg/mL
Standard Deviation 5.1209
|
11.893 mcg/mL
Standard Deviation 6.3203
|
|
Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab
Pre-dose at Week 96
|
10.082 mcg/mL
Standard Deviation 4.5371
|
12.426 mcg/mL
Standard Deviation 5.6925
|
|
Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab
Week 104
|
10.080 mcg/mL
Standard Deviation 5.2596
|
12.301 mcg/mL
Standard Deviation 6.0099
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) up to Week 52Population: Immunogenicity analysis set included all participants who received at least 1 administration of guselkumab and had at least 1 observed post dose immune response data. This outcome measure was planned to be analyzed for specified arm only.
Number of participants with anti-guselkumab antibody were reported. Serum samples were assessed for anti-drug antibodies.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=29 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Main Study: Number of Participants With Anti-Guselkumab Antibody
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: From Week 52 up to Week 104Population: Immunogenicity analysis set included all participants who received at least 1 administration of guselkumab and had at least 1 observed post dose immune response data.
Number of participants with anti-guselkumab antibody were reported. Serum samples were assessed for anti-drug antibodies.
Outcome measures
| Measure |
Main Study: Group A: Guselkumab
n=25 Participants
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=26 Participants
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
|---|---|---|
|
Long-term Extension (LTE) Study: Number of Participants With Anti-guselkumab Antibody
|
6 Participants
|
0 Participants
|
Adverse Events
Main Study: Group A: Guselkumab
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Main Study: Group B: Placebo
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
LTE Period: Group A: Guselkumab Then Guselkumab
Serious events: 1 serious events
Other events: 22 other events
Deaths: 1 deaths
LTE Period: Group B: Placebo Then Guselkumab
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Study: Group A: Guselkumab
n=29 participants at risk
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 participants at risk
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
LTE Period: Group A: Guselkumab Then Guselkumab
n=25 participants at risk
Participants who received guselkumab and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 200 mg SC injection and placebo IV infusion at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112.
|
LTE Period: Group B: Placebo Then Guselkumab
n=26 participants at risk
Participants who received placebo and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 400 mg IV infusion and placebo SC injection at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112.
|
|---|---|---|---|---|
|
Cardiac disorders
Myocarditis
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
4.0%
1/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Gastrointestinal disorders
Ileus Paralytic
|
3.4%
1/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Gastrointestinal disorders
Pneumatosis Intestinalis
|
3.4%
1/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Covid-19
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.7%
1/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Musculoskeletal and connective tissue disorders
Systemic Scleroderma
|
3.4%
1/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
Other adverse events
| Measure |
Main Study: Group A: Guselkumab
n=29 participants at risk
Participants received guselkumab 400 milligrams (mg) intravenous (IV) infusion (induction dosing) at Weeks 0, 4, and 8 followed by guselkumab 200 mg subcutaneous (SC) injection (maintenance dosing) every 4 weeks (Q4W) from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
Main Study: Group B: Placebo
n=27 participants at risk
Participants received placebo (matched to guselkumab 400 mg) IV infusion (induction dosing) at Weeks 0, 4, and 8 followed by placebo (matched to guselkumab 200 mg) SC injection (maintenance dosing) Q4W from Week 12 until Week 48. After Week 52, participants who did not enter LTE underwent the safety follow up until Week 60.
|
LTE Period: Group A: Guselkumab Then Guselkumab
n=25 participants at risk
Participants who received guselkumab and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 200 mg SC injection and placebo IV infusion at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112.
|
LTE Period: Group B: Placebo Then Guselkumab
n=26 participants at risk
Participants who received placebo and completed the main study (Week 0 through 52, that is, after the Week 48 evaluation, prior to Week 52 evaluation) and who, in the opinion of the investigator benefited from continued treatment, entered LTE period and received guselkumab 400 mg IV infusion and placebo SC injection at Weeks 52, 56, and 60 followed by guselkumab 200 mg SC injection q4w from Week 64 until Week 100. After Week 100, participants were followed up until Week 112.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.1%
3/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.8%
1/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Eye disorders
Conjunctival Haemorrhage
|
3.4%
1/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.5%
3/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
4.0%
1/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Gastrointestinal disorders
Stomatitis
|
6.9%
2/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
8.0%
2/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
General disorders
Malaise
|
10.3%
3/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.1%
3/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
General disorders
Pyrexia
|
31.0%
9/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
51.9%
14/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
16.0%
4/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
26.9%
7/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Cellulitis
|
3.4%
1/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Covid-19
|
6.9%
2/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
28.0%
7/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
23.1%
6/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Cystitis
|
3.4%
1/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
4.0%
1/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.7%
2/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Dermatophytosis of Nail
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Folliculitis
|
10.3%
3/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.1%
3/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.8%
1/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
8.0%
2/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Herpes Zoster
|
3.4%
1/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.7%
1/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.5%
3/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Influenza
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
15.4%
4/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Nasopharyngitis
|
20.7%
6/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
48.0%
12/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
34.6%
9/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Paronychia
|
13.8%
4/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
18.5%
5/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
8.0%
2/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.7%
2/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
8.0%
2/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.8%
1/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Streptococcal Infection
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
8.0%
2/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Infections and infestations
Tinea Pedis
|
6.9%
2/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.1%
3/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
10.3%
3/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.1%
3/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
12.0%
3/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
3.4%
1/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
4.0%
1/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.8%
1/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.7%
1/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
4.0%
1/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.5%
3/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.1%
3/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
25.9%
7/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
25.9%
7/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
2/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
25.9%
7/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
4.0%
1/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.8%
1/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
12.0%
3/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.8%
1/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
2/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.7%
1/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Nervous system disorders
Headache
|
6.9%
2/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.7%
1/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
8.0%
2/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.7%
2/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.4%
2/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
4.0%
1/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.1%
3/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
8.0%
2/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.8%
1/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
17.2%
5/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
14.8%
4/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
7.7%
2/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
25.9%
7/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
4.0%
1/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.1%
3/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
0.00%
0/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/29 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
11.1%
3/27 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
4.0%
1/25 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
3.8%
1/26 • All-cause mortality: Main Study: From screening (Week [-6]) up to Week 60 and LTE Period: From Week 52 up to Week 112 ; SAEs and Non-serious AEs: Main Study: From baseline (Week 0) up to Week 60; LTE Period: From Week 52 up to Week 112
The safety analysis set included all randomized participants who received at least 1 dose (complete or partial) of study intervention during main study and LTE period. During LTE, AEs were analyzed per treatment group as participants received guselkumab and placebo at the same time so AEs per intervention could not be determined.
|
Additional Information
Senior Director Clinical Research MD
Janssen Pharmaceutical K.K.
Phone: 844-434-4210
Email: [email protected]
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 to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER