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A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT03517722
Recruitment Status : Terminated (Study terminated early as a result of the outcome of the pre-planned Interim Analysis)
First Posted : May 7, 2018
Results First Posted : March 9, 2022
Last Update Posted : January 3, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Interventions Drug: Placebo
Drug: Ustekinumab (approximately 6 mg/kg)
Drug: Ustekinumab 90 mg
Enrollment 516
Recruitment Details  
Pre-assignment Details Participants received study drug up to Week 113, but were assessed for safety up to Week 130 (that is, after study termination).
Arm/Group Title Placebo to Ustekinumab Ustekinumab
Hide Arm/Group Description Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113. Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
Period Title: Double Blind Period: Week 0-52
Started 208 308
Treated 208 307
Completed 105 153
Not Completed 103 155
Reason Not Completed
Adverse Event             9             11
Death             0             4
Lack of Efficacy             2             3
Pregnancy             0             1
Protocol Violation             1             0
Withdrawal by Subject             11             11
Study Terminated by Sponsor             76             120
Other             4             3
Initiated prohibited medication             0             2
Period Title: Open-label Extension Period: Week 52-113
Started 88 137
Completed 0 0
Not Completed 88 137
Reason Not Completed
Adverse Event             0             1
Lack of Efficacy             0             1
Withdrawal by Subject             1             1
Study Terminated by Sponsor             87             134
Arm/Group Title Placebo to Ustekinumab Ustekinumab Total
Hide Arm/Group Description Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113. Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113. Total of all reporting groups
Overall Number of Baseline Participants 208 308 516
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 308 participants 516 participants
<=18 years
3
   1.4%
1
   0.3%
4
   0.8%
Between 18 and 65 years
191
  91.8%
294
  95.5%
485
  94.0%
>=65 years
14
   6.7%
13
   4.2%
27
   5.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 208 participants 308 participants 516 participants
44.5  (12.31) 42.9  (11.38) 43.5  (11.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 308 participants 516 participants
Female
191
  91.8%
291
  94.5%
482
  93.4%
Male
17
   8.2%
17
   5.5%
34
   6.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 308 participants 516 participants
Hispanic or Latino
34
  16.3%
45
  14.6%
79
  15.3%
Not Hispanic or Latino
172
  82.7%
263
  85.4%
435
  84.3%
Unknown or Not Reported
2
   1.0%
0
   0.0%
2
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 308 participants 516 participants
American Indian or Alaska Native
2
   1.0%
7
   2.3%
9
   1.7%
Asian
46
  22.1%
57
  18.5%
103
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   0.6%
2
   0.4%
Black or African American
18
   8.7%
24
   7.8%
42
   8.1%
White
136
  65.4%
208
  67.5%
344
  66.7%
More than one race
1
   0.5%
0
   0.0%
1
   0.2%
Unknown or Not Reported
5
   2.4%
10
   3.2%
15
   2.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 308 participants 516 participants
ARGENTINA
15
   7.2%
13
   4.2%
28
   5.4%
BULGARIA
11
   5.3%
16
   5.2%
27
   5.2%
CANADA
0
   0.0%
2
   0.6%
2
   0.4%
CHINA
4
   1.9%
4
   1.3%
8
   1.6%
COLOMBIA
7
   3.4%
10
   3.2%
17
   3.3%
GERMANY
9
   4.3%
10
   3.2%
19
   3.7%
HUNGARY
3
   1.4%
11
   3.6%
14
   2.7%
JAPAN
21
  10.1%
25
   8.1%
46
   8.9%
LITHUANIA
10
   4.8%
11
   3.6%
21
   4.1%
POLAND
17
   8.2%
21
   6.8%
38
   7.4%
PORTUGAL
0
   0.0%
1
   0.3%
1
   0.2%
RUSSIAN FEDERATION
11
   5.3%
19
   6.2%
30
   5.8%
SERBIA
14
   6.7%
28
   9.1%
42
   8.1%
SOUTH AFRICA
4
   1.9%
8
   2.6%
12
   2.3%
SOUTH KOREA
0
   0.0%
5
   1.6%
5
   1.0%
SPAIN
4
   1.9%
6
   1.9%
10
   1.9%
TAIWAN
11
   5.3%
14
   4.5%
25
   4.8%
THAILAND
7
   3.4%
5
   1.6%
12
   2.3%
UKRAINE
8
   3.8%
22
   7.1%
30
   5.8%
UNITED STATES
52
  25.0%
77
  25.0%
129
  25.0%
1.Primary Outcome
Title Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52
Hide Description SRI-4 response:>=4-point reduction in SLEDAI-2K total score, no British Isles Lupus Assessment Group (BILAG) A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in Physician's Global Assessment(PGA).SLEDAI measures disease activity in 9 organ systems,higher scores=more severe disease activity.Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The projected full analysis set (FAS) was defined as those participants (participants who received at least 1 dose [partial or complete,intravenous [IV] or subcutaneous [SC] of study agent) who should have had a given visit based upon their latest scheduled study visit. Participants were set to non-responders if they met treatment failure (TF) or had data missing.
Arm/Group Title Placebo to Ustekinumab Ustekinumab
Hide Arm/Group Description:
Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113.
Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
Overall Number of Participants Analyzed 116 173
Measure Type: Number
Unit of Measure: percentage of participants
56.0 43.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo to Ustekinumab, Ustekinumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.4 to 1.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to First Flare
Hide Description Time to flare is defined as the time (in days) post baseline when the first flare occurs. It was calculated with flare defined as either 1 or more BILAG A (severe disease activity) or 2 or more new BILAG B (moderate disease activity) domain scores relative to baseline. BILAG was defined as a measure of alterations or intensification to therapy consisting of 97 questions in 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. BILAG A flare was defined as at least 1 new BILAG A scores. BILAG B flare was defined as at least 2 new BILAG B scores.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is projected FAS. Participants were set to have flare if they met TF criteria (exceeded baseline dose of permitted SLE medications, initiated a new permitted SLE medication, initiated new protocol-prohibited medication or discontinued study agent for any reason prior to Week 52).
Arm/Group Title Placebo to Ustekinumab Ustekinumab
Hide Arm/Group Description:
Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113.
Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
Overall Number of Participants Analyzed 116 173
Mean (Standard Deviation)
Unit of Measure: days
Time to First BILAG Flare 200.4  (121.27) 204.7  (107.82)
Time to First BILAG A Flare 201.4  (122.83) 203.1  (108.37)
Time to First BILAG B Flare 218.1  (125.00) 208.7  (107.51)
3.Secondary Outcome
Title Percentage of Participants With an SRI-4 Composite Response at Week 24
Hide Description SRI-4 response:>=4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no BILAG A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in PGA.SLEDAI measures disease activity in 9 organ systems, higher scores=more severe disease activity. Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included projected analysis set among participants who had or should have had a Week 24 visit based upon their last scheduled visit.
Arm/Group Title Placebo to Ustekinumab Ustekinumab
Hide Arm/Group Description:
Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113.
Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
Overall Number of Participants Analyzed 116 173
Measure Type: Number
Unit of Measure: percentage of participants
56 45.7
4.Secondary Outcome
Title Percentage of Participants With 50 Percent (%) Improvement in Joints With Pain and Signs of Inflammation (Active Joints) at Week 52
Hide Description The percentage of participants who achieved at least 50% improvement from baseline in number of joints with pain and signs of inflammation at Week 52 for participants with at least 4 joints with pain and signs of inflammation at baseline were reported.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is projected analysis set which included participants who had at least 4 joints with pain and signs of inflammation at baseline. Here, 'N' (number of participants analyzed) refers to participants evaluable included participants who had or should have had a Week 52 visit based upon their last scheduled visit and the date of trial termination.
Arm/Group Title Placebo to Ustekinumab Ustekinumab
Hide Arm/Group Description:
Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113.
Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
Overall Number of Participants Analyzed 101 153
Measure Type: Number
Unit of Measure: percentage of participants
66.3 64.7
5.Secondary Outcome
Title Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40 and Sustain That Change Through Week 52
Hide Description Reduction of glucocorticoid dose was defined as a reduction in average daily oral glucocorticoid dose by at least 50% (relative to the baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to the baseline dose) so that the average daily dose was reduced to less than or equal to (<=) 7.5 milligram (mg) (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who, at baseline, were receiving oral glucocorticoids.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is projected analysis set which included participants who received glucocorticoids at baseline. Here, 'N' (number of participants analyzed) refers to participants evaluable including participants who had or should have had a Week 52 visit based upon their last scheduled visit and the date of trial termination. Participants were set to non-responders if they met TF or had data missing.
Arm/Group Title Placebo to Ustekinumab Ustekinumab
Hide Arm/Group Description:
Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113.
Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
Overall Number of Participants Analyzed 92 140
Measure Type: Number
Unit of Measure: percentage of participants
29.3 44.3
6.Secondary Outcome
Title Percentage of Participants With at Least a 50% Improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 52
Hide Description Percentage of participants achieving at least 50% improvement in CLASI activity score at Week 52 reported in participants with a CLASI activity score of 4 or greater at baseline. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI activity score ranges from 0-70 with lower score being improved. Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is projected FAS. Here, 'N' (number of participants analyzed) refers to participants who had or should have had a Week 52 visit based upon their last scheduled visit and the date of trial termination and with a CLASI activity score of 4 or greater at baseline. Participants were set to non-responders if they met TF or had data missing.
Arm/Group Title Placebo to Ustekinumab Ustekinumab
Hide Arm/Group Description:
Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113.
Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
Overall Number of Participants Analyzed 93 135
Measure Type: Number
Unit of Measure: percentage of participants
55.9 40.7
7.Secondary Outcome
Title Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40, Sustained That Change Through Week 52, and Achieved an SRI-4 Composite Response at Week 52
Hide Description Percentage of participants with reduction in glucocorticoid dose by Week 40, its sustenance through Week 52, and SRI 4 composite response at Week 52 were reported. Reduction of glucocorticoid dose was defined as reduction in average daily oral glucocorticoid dose by at least 50% (relative to baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to baseline dose) so that average daily dose is reduced to <=7.5 mg (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who,at baseline,were receiving oral glucocorticoids. SRI-4 was defined as composite of at least 4-point improvement in SLEDAI-2K score of 0=no symptoms to 105=presence of all defined symptoms with higher scores representing increased disease activity),no worsening in BILAG and no worsening in PGA.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is projected analysis set which included participants who received glucocorticoids at baseline. Here, 'N' (number of participants analyzed) refers to participants evaluable included participants who had or should have had a Week 52 visit based upon their last scheduled visit and the date of trial termination. Participants were set to non-responders if they met TF or had data missing.
Arm/Group Title Placebo to Ustekinumab Ustekinumab
Hide Arm/Group Description:
Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period crossed over to receive ustekinumab 90 mg SC q8w through Week 113.
Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to {<=} 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the open-label extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
Overall Number of Participants Analyzed 92 140
Measure Type: Number
Unit of Measure: percentage of participants
23.9 30.0
Time Frame Up to Week 130
Adverse Event Reporting Description Safety analysis set included participants who were randomized, received at least 1 dose (partial or complete, intravenous or subcutaneous) of ustekinumab or placebo, and contributed any safety data after the start of study treatment. Participants received study drug up to Week 113, but were assessed for safety up to Week 130 (that is, after study termination). Participants were analyzed according to the actual treatment received.
 
Arm/Group Title Placebo (Prior to Entering (Long Term Extension [LTE]) Placebo to Ustekinumab (After Entering LTE) Ustekinumab (Through Week 113)
Hide Arm/Group Description Participants received matching placebo to ustekinumab intravenously (IV) 6 milligrams per kilogram (mg/kg) IV based on body weight at Week 0 followed by matching placebo to ustekinumab subcutaneously (SC) 90 mg at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Participants who entered the open-label extension period at Week 52 crossed over to receive ustekinumab 90 mg SC q8w through Week 113. Participants received ustekinumab 6 mg/kg IV based on body weight (ustekinumab 260 mg [weight less than or equal to (<=) 55 kg]; ustekinumab 390 mg [weight greater than {>} 55 kg and <= 85 kg] at Week 0 followed by ustekinumab 90 mg SC at Week 8 and q8w thereafter through Week 48 during double-blind period. At Week 52, participants who entered the extension period continued to receive ustekinumab 90 mg SC q8w through Week 113.
All-Cause Mortality
Placebo (Prior to Entering (Long Term Extension [LTE]) Placebo to Ustekinumab (After Entering LTE) Ustekinumab (Through Week 113)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/208 (0.48%)   0/88 (0.00%)   5/307 (1.63%) 
Hide Serious Adverse Events
Placebo (Prior to Entering (Long Term Extension [LTE]) Placebo to Ustekinumab (After Entering LTE) Ustekinumab (Through Week 113)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/208 (13.46%)   5/88 (5.68%)   44/307 (14.33%) 
Blood and lymphatic system disorders       
Thrombocytopenia * 1  2/208 (0.96%)  0/88 (0.00%)  1/307 (0.33%) 
Cardiac disorders       
Acute Myocardial Infarction * 1  2/208 (0.96%)  1/88 (1.14%)  0/307 (0.00%) 
Bradycardia * 1  0/208 (0.00%)  1/88 (1.14%)  0/307 (0.00%) 
Cardiac Failure * 1  0/208 (0.00%)  0/88 (0.00%)  2/307 (0.65%) 
Pericardial Effusion * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Eye disorders       
Retinal Detachment * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Visual Impairment * 1  0/208 (0.00%)  1/88 (1.14%)  0/307 (0.00%) 
Gastrointestinal disorders       
Abdominal Hernia * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Abdominal Pain * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Colitis * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Gastritis * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Pancreatitis Acute * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Small Intestinal Obstruction * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Hepatobiliary disorders       
Hepatorenal Syndrome * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Infections and infestations       
Bronchitis * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Covid-19 * 1  0/208 (0.00%)  0/88 (0.00%)  4/307 (1.30%) 
Diverticulitis * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Endocarditis Staphylococcal * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Gastroenteritis * 1  0/208 (0.00%)  0/88 (0.00%)  2/307 (0.65%) 
Herpes Zoster * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Infected Bite * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Nosocomial Infection * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Pneumonia * 1  1/208 (0.48%)  0/88 (0.00%)  4/307 (1.30%) 
Pulmonary Tuberculosis * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Sepsis * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Tonsillitis * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Urinary Tract Infection * 1  2/208 (0.96%)  0/88 (0.00%)  1/307 (0.33%) 
Urosepsis * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Viral Infection * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Vulval Cellulitis * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Injury, poisoning and procedural complications       
Fall * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Implantation Complication * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Infusion Related Reaction * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Patella Fracture * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Post Procedural Fever * 1  0/208 (0.00%)  1/88 (1.14%)  0/307 (0.00%) 
Post Procedural Haemorrhage * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Splenic Rupture * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Ulna Fracture * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Metabolism and nutrition disorders       
Electrolyte Imbalance * 1  1/208 (0.48%)  0/88 (0.00%)  1/307 (0.33%) 
Musculoskeletal and connective tissue disorders       
Intervertebral Disc Protrusion * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Osteonecrosis * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Systemic Lupus Erythematosus * 1  4/208 (1.92%)  0/88 (0.00%)  2/307 (0.65%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acoustic Neuroma * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Diffuse Large B-Cell Lymphoma * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Gastric Cancer * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Nervous system disorders       
Amnesia * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Embolic Stroke * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Facial Paralysis * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Haemorrhagic Stroke * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Neuropsychiatric Lupus * 1  0/208 (0.00%)  0/88 (0.00%)  2/307 (0.65%) 
Seizure * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Pregnancy, puerperium and perinatal conditions       
Hyperemesis Gravidarum * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Renal and urinary disorders       
Haematuria * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Hydronephrosis * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Lupus Nephritis * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Nephritic Syndrome * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Nephrolithiasis * 1  0/208 (0.00%)  0/88 (0.00%)  2/307 (0.65%) 
Neurogenic Bladder * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Renal Colic * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Reproductive system and breast disorders       
Benign Prostatic Hyperplasia * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Ovarian Cyst * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Respiratory, thoracic and mediastinal disorders       
Acute Respiratory Failure * 1  0/208 (0.00%)  0/88 (0.00%)  2/307 (0.65%) 
Lupus Pleurisy * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Pleural Effusion * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Pneumonitis * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Pulmonary Hypertension * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Respiratory Failure * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Skin and subcutaneous tissue disorders       
Dermal Cyst * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Hypersensitivity Vasculitis * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Pemphigoid * 1  1/208 (0.48%)  0/88 (0.00%)  0/307 (0.00%) 
Toxic Epidermal Necrolysis * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Vascular disorders       
Aortic Aneurysm * 1  0/208 (0.00%)  1/88 (1.14%)  0/307 (0.00%) 
Deep Vein Thrombosis * 1  0/208 (0.00%)  1/88 (1.14%)  0/307 (0.00%) 
Hypotension * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Hypovolaemic Shock * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
Lupus Vasculitis * 1  0/208 (0.00%)  0/88 (0.00%)  1/307 (0.33%) 
1
Term from vocabulary, MedDRA Version 23.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Prior to Entering (Long Term Extension [LTE]) Placebo to Ustekinumab (After Entering LTE) Ustekinumab (Through Week 113)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   60/208 (28.85%)   3/88 (3.41%)   79/307 (25.73%) 
Infections and infestations       
Nasopharyngitis * 1  19/208 (9.13%)  2/88 (2.27%)  24/307 (7.82%) 
Upper Respiratory Tract Infection * 1  17/208 (8.17%)  0/88 (0.00%)  25/307 (8.14%) 
Urinary Tract Infection * 1  20/208 (9.62%)  0/88 (0.00%)  26/307 (8.47%) 
Nervous system disorders       
Headache * 1  14/208 (6.73%)  1/88 (1.14%)  19/307 (6.19%) 
1
Term from vocabulary, MedDRA Version 23.0
*
Indicates events were collected by non-systematic assessment
Due to study termination, the open-label extension phase didn't reach the planned duration till Week 176. However, participants were assessed for safety up to Week 130 (that is, after study termination) and received study drug up to Week 113.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: DIRECTOR CLINICAL RESEARCH GI.
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03517722    
Other Study ID Numbers: CR108440
2017-001489-53 ( EudraCT Number )
CNTO1275SLE3001 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: April 13, 2018
First Posted: May 7, 2018
Results First Submitted: November 3, 2021
Results First Posted: March 9, 2022
Last Update Posted: January 3, 2024