Trial Outcomes & Findings for A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus (NCT NCT03517722)

Last Updated: 2025-04-29

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

516 participants

Primary outcome timeframe

Week 52

Results posted on

2025-04-29

Participant Flow

Participants received study drug up to Week 113, but were assessed for safety up to Week 130 (that is, after study termination).

Participant milestones

Participant milestones
Measure	Placebo to Ustekinumab 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.	Ustekinumab 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.
Double Blind Period: Week 0-52 STARTED	208	308
Double Blind Period: Week 0-52 Treated	208	307
Double Blind Period: Week 0-52 COMPLETED	105	153
Double Blind Period: Week 0-52 NOT COMPLETED	103	155
Open-label Extension Period: Week 52-113 STARTED	88	137
Open-label Extension Period: Week 52-113 COMPLETED	0	0
Open-label Extension Period: Week 52-113 NOT COMPLETED	88	137

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo to Ustekinumab 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.	Ustekinumab 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.
Double Blind Period: Week 0-52 Adverse Event	9	11
Double Blind Period: Week 0-52 Death	0	4
Double Blind Period: Week 0-52 Lack of Efficacy	2	3
Double Blind Period: Week 0-52 Pregnancy	0	1
Double Blind Period: Week 0-52 Protocol Violation	1	0
Double Blind Period: Week 0-52 Withdrawal by Subject	11	11
Double Blind Period: Week 0-52 Study Terminated by Sponsor	76	120
Double Blind Period: Week 0-52 Other	4	3
Double Blind Period: Week 0-52 Initiated prohibited medication	0	2
Open-label Extension Period: Week 52-113 Adverse Event	0	1
Open-label Extension Period: Week 52-113 Lack of Efficacy	0	1
Open-label Extension Period: Week 52-113 Withdrawal by Subject	1	1
Open-label Extension Period: Week 52-113 Study Terminated by Sponsor	87	134

Baseline Characteristics

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo to Ustekinumab n=208 Participants 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.	Ustekinumab n=308 Participants 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 n=516 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	191 Participants n=5 Participants	294 Participants n=7 Participants	485 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Age, Continuous	44.5 years STANDARD_DEVIATION 12.31 • n=5 Participants	42.9 years STANDARD_DEVIATION 11.38 • n=7 Participants	43.5 years STANDARD_DEVIATION 11.78 • n=5 Participants
Sex: Female, Male Female	191 Participants n=5 Participants	291 Participants n=7 Participants	482 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	45 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	172 Participants n=5 Participants	263 Participants n=7 Participants	435 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	46 Participants n=5 Participants	57 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	24 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) White	136 Participants n=5 Participants	208 Participants n=7 Participants	344 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment ARGENTINA	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment BULGARIA	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment CANADA	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment CHINA	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment COLOMBIA	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment GERMANY	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment HUNGARY	3 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment JAPAN	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment LITHUANIA	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment POLAND	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment PORTUGAL	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment RUSSIAN FEDERATION	11 Participants n=5 Participants	19 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment SERBIA	14 Participants n=5 Participants	28 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment SOUTH AFRICA	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment SOUTH KOREA	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment SPAIN	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment TAIWAN	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment THAILAND	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment UKRAINE	8 Participants n=5 Participants	22 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment UNITED STATES	52 Participants n=5 Participants	77 Participants n=7 Participants	129 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo to Ustekinumab n=116 Participants 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.	Ustekinumab n=173 Participants 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.
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52	56.0 percentage of participants	43.9 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo to Ustekinumab n=116 Participants 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.	Ustekinumab n=173 Participants 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.
Time to First Flare Time to First BILAG Flare	200.4 days Standard Deviation 121.27	204.7 days Standard Deviation 107.82
Time to First Flare Time to First BILAG A Flare	201.4 days Standard Deviation 122.83	203.1 days Standard Deviation 108.37
Time to First Flare Time to First BILAG B Flare	218.1 days Standard Deviation 125.00	208.7 days Standard Deviation 107.51

SECONDARY outcome

Timeframe: Week 24

Population: Population analyzed included projected analysis set among participants who had or should have had a Week 24 visit based upon their last scheduled visit.

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).

Outcome measures

Outcome measures
Measure	Placebo to Ustekinumab n=116 Participants 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.	Ustekinumab n=173 Participants 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.
Percentage of Participants With an SRI-4 Composite Response at Week 24	56 percentage of participants	45.7 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo to Ustekinumab n=101 Participants 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.	Ustekinumab n=153 Participants 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.
Percentage of Participants With 50 Percent (%) Improvement in Joints With Pain and Signs of Inflammation (Active Joints) at Week 52	66.3 percentage of participants	64.7 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo to Ustekinumab n=92 Participants 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.	Ustekinumab n=140 Participants 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.
Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40 and Sustain That Change Through Week 52	29.3 percentage of participants	44.3 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo to Ustekinumab n=93 Participants 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.	Ustekinumab n=135 Participants 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.
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	55.9 percentage of participants	40.7 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo to Ustekinumab n=92 Participants 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.	Ustekinumab n=140 Participants 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.
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	23.9 percentage of participants	30.0 percentage of participants

Adverse Events

Placebo (Prior to Entering (Long Term Extension [LTE])

Serious events: 28 serious events

Other events: 60 other events

Deaths: 1 deaths

Placebo to Ustekinumab (After Entering LTE)

Serious events: 5 serious events

Other events: 3 other events

Deaths: 0 deaths

Ustekinumab (Through Week 113)

Serious events: 44 serious events

Other events: 79 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo (Prior to Entering (Long Term Extension [LTE]) n=208 participants at risk 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.	Placebo to Ustekinumab (After Entering LTE) n=88 participants at risk Participants who entered the open-label extension period at Week 52 crossed over to receive ustekinumab 90 mg SC q8w through Week 113.	Ustekinumab (Through Week 113) n=307 participants at risk 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.
Infections and infestations Nasopharyngitis	9.1% 19/208 • Up to Week 130 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.	2.3% 2/88 • Up to Week 130 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.	7.8% 24/307 • Up to Week 130 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.
Infections and infestations Upper Respiratory Tract Infection	8.2% 17/208 • Up to Week 130 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.	0.00% 0/88 • Up to Week 130 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.	8.1% 25/307 • Up to Week 130 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.
Infections and infestations Urinary Tract Infection	9.6% 20/208 • Up to Week 130 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.	0.00% 0/88 • Up to Week 130 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.	8.5% 26/307 • Up to Week 130 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.
Nervous system disorders Headache	6.7% 14/208 • Up to Week 130 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.	1.1% 1/88 • Up to Week 130 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.	6.2% 19/307 • Up to Week 130 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.

Additional Information

DIRECTOR CLINICAL RESEARCH GI.

Janssen Research & Development, LLC

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.
Publication restrictions are in place

Restriction type: OTHER