A Phase 2a, Efficacy and Safety Study of Ustekinumab in S... | NCT02349061 | Trialant
NCT02349061
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Mar 24, 2020Actual
Enrollment
102Actual
Phase
Phase 2
Conditions
Lupus Erythematosus, Systemic
Interventions
Ustekinumab IV
Placebo Infusion
Placebo SC
Ustekinumab SC
Concomitant Medication
Countries
United States
Argentina
Australia
Germany
Hungary
Mexico
Poland
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02349061
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR106661
Secondary IDs
ID
Type
Description
Link
CNTO1275SLE2001
Other Identifier
Janssen Research & Development, LLC
2014-005000-19
EudraCT Number
Brief Title
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Mar 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 15, 2015Actual
Primary Completion Date
May 15, 2017Actual
Completion Date
Mar 13, 2019Actual
First Submitted Date
Jan 23, 2015
First Submission Date that Met QC Criteria
Jan 23, 2015
First Posted Date
Jan 28, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
May 15, 2018
Results First Submitted that Met QC Criteria
May 15, 2018
Results First Posted Date
Jun 12, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 11, 2020
Last Update Posted Date
Mar 24, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis, kidney problems, and anemia, among other problems).
Detailed Description
A multicenter (more than one medical research center involved in study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study drug), placebo-controlled, proof-of-concept study of ustekinumab in participants with active systemic lupus erythematosus. Participants will be screened to achieve all inclusion criteria and none exclusion criteria and will then receive either ustekinumab or placebo along with concomitant background medicine. Participants will be primarily assessed for response using the Systemic Lupus Erythematosus Response Index 2000 (SRI-4). Participants' safety will be assessed throughout the study.
Conditions Module
Conditions
Lupus Erythematosus, Systemic
Keywords
Systemic Lupus Erythematosus
Ustekinumab
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
102Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ustekinumab plus Concomitant Medication
Experimental
Participants will receive weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0 followed by ustekinumab 90 mg subcutaneously (SC) every 8 weeks (q8w) up to Week 40. Participants who meet the study extension inclusion criteria will continue to receive ustekinumab 90 mg SC q8w starting at Week 48 or 56 through Week 104. Participants will continue stable concomitant treatment through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48. Participants who complete or discontinue study treatment will be evaluated for 16 additional Weeks of safety follow-up.
Drug: Ustekinumab IV
Drug: Ustekinumab SC
Other: Concomitant Medication
Placebo followed by Ustekinumab plus Concomitant Medication
Experimental
Participants will receive placebo intravenously at Week 0 followed by placebo subcutaneously at Weeks 8 and 16. At week 24 participants will receive ustekinumab SC q8w up to Week 40. Participants who meet the study extension inclusion criteria will continue to receive ustekinumab 90 mg SC q8w starting at Week 48 or 56 through Week 104. Participants will continue stable concomitant treatment through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48. Participants who complete or discontinue study treatment will be evaluated for 16 additional Weeks of safety follow-up.
Drug: Placebo Infusion
Drug: Placebo SC
Drug: Ustekinumab SC
Other: Concomitant Medication
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ustekinumab IV
Drug
Weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0.
Ustekinumab plus Concomitant Medication
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24
SRI-4 response was defined as greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA). Composite response is defined as SRI-4 response in participants who do not meet treatment failure criteria. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well (0)-very poor (10).
Week 24
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) Score at Week 24
The SLEDAI-2K is an established, validated SLE activity index. It is based on the presence of 24 features in 9 organ systems and measures disease activity in SLE patients in the previous 30 days. It is weighted according to the feature. Features are scored by the assessing physician if present within the last 30 days with more severe features having higher scores, and then simply added to determine the total SLEDAI 2K score, which ranges from 0 to 105, with higher scores representing increased disease activity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects must have documented medical history to meet SLICC classification criteria for SLE for a minimum of 3 months prior to first dose
At least 1 well-documented (subject file, referring physician letter, or laboratory result), unequivocally positive, documented test for autoantibodies in medical history including either of the following: ANA, and/or anti-dsDNA antibodies, and/or anti-Smith antibodies
At least 1 unequivocally positive autoantibody test including ANA and/or anti-dsDNA antibodies and/or anti-Smith antibodies detected during screening
At least 1 BILAG A and/or 2 BILAG B domain scores observed during screening prior to first administration of study agent
Demonstrate active disease based on SLEDAI-2K score greater than or equal to (>=) 6 observed during screening and assessed approximately 2 to 6 weeks prior to randomization. Must also have SLEDAI-2K score >= 4 for clinical features (ie, SLEDAI excluding laboratory results) at Week 0 prior to the first administration of study agent
Exclusion Criteria:
Have other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis or active Lyme disease
Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent
Have received systemic or topical cream/ointment preparations of cyclosporine A or other systemic immunomodulatory agents other than those described in inclusion criteria within the past 3 months prior to first administration of study agent
Have received a single B cell targeting agent within 3 months prior to first study agent administration; or received more than 1 previous B cell targeting therapy including belimumab or epratuzamab within 6 months prior to first administration of the study agent; or received B cell depleting therapy (eg, rituximab) within 12 months prior to first administration of the study agent or have evidence of continued B-cell depletion following such therapy
Have ever received ustekinumab
Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin that has been treated with no evidence of recurrence for at least 3 months before the first study agent administration and carcinoma in situ of the cervix that has been surgically cured)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
van Vollenhoven RF, Hahn BH, Tsokos GC, Lipsky P, Gordon RM, Fei K, Lo KH, Chevrier M, Rose S, Berry P, Yao Z, Karyekar CS, Zuraw Q. Efficacy and Safety of Ustekinumab in Patients With Active Systemic Lupus Erythematosus: Results of a Phase II Open-label Extension Study. J Rheumatol. 2022 Apr;49(4):380-387. doi: 10.3899/jrheum.210805. Epub 2021 Dec 1.
166 participants were screened during the study, 102 were enrolled/randomized and treated.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo - Ustekinumab
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16. At Week 24, participants who completed were crossed-over to receive ustekinumab 90 milligram (mg) SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration.
Periods
Title
Milestones
Reasons Not Completed
Main Study: PCP (Up to Week 24)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 18, 2017
May 15, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
United Kingdom
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
STELARA
Placebo Infusion
Drug
Placebo intravenously at Week 0.
Placebo followed by Ustekinumab plus Concomitant Medication
Placebo SC
Drug
Placebo subcutaneously at Weeks 8 and 16.
Placebo followed by Ustekinumab plus Concomitant Medication
Ustekinumab SC
Drug
Ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40 and up to Week 104 in study extension (for eligible participants)
Placebo followed by Ustekinumab plus Concomitant Medication
Ustekinumab plus Concomitant Medication
Concomitant Medication
Other
Concomitant treatment (mycophenolate, azathioprine/6-mercaptopurine, methotrexate, hydroxychloroquine and/or chloroquine, oral corticosteroids, NSAIDs, antihypertensive medications, and topical medications) through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48.
Placebo followed by Ustekinumab plus Concomitant Medication
Ustekinumab plus Concomitant Medication
Baseline, Week 24
Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Score at Week 24
PGA was recorded on a visual analogue scale (VAS; 0.0 to 10.0 centimeter [cm]). The scale for the physician's assessment ranges for 'no lupus activity' (0.0) to 'extremely active lupus' (10.0).
Baseline, Week 24
Number of Participants With BILAG-based Combined Lupus Assessment (BICLA) Response at Week 24
BICLA response defined as participants meeting following criteria: 1. BILAG improvement (all BILAG A scores at baseline improved to either B, C or D and all BILAG B scores at baseline improved to C or D and no worsening in disease activity defined as no new BILAG A scores and <= 1 new BILAG B score) and 2. no worsening of total SLEDAI-2K from baseline 3. < 1 cm increase in PGA and 4. no treatment failure criteria met. BILAG: assesses disease extent, severity (range: A [severe] to E [no disease]). SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PGA: assesses worsening in participant's general health status (0.0= 'no lupus activity' to 10.0 = 'extremely active lupus').
Week 24
Change From Baseline in Number of Joints With Pain and Signs of Inflammation at Week 24
Change from baseline in number of joints (active joint) with pain and signs of inflammation (tenderness, swelling or effusion) for participants with at least 2 affected joints at baseline were reported. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion).
Cesaroni M, Seridi L, Loza MJ, Schreiter J, Sweet K, Franks C, Ma K, Orillion A, Campbell K, M Gordon R, Branigan P, Lipsky P, van Vollenhoven R, Hahn BH, Tsokos GC, Chevrier M, Rose S, Baribaud F, Jordan J. Suppression of Serum Interferon-gamma Levels as a Potential Measure of Response to Ustekinumab Treatment in Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2021 Mar;73(3):472-477. doi: 10.1002/art.41547. Epub 2021 Feb 1.
van Vollenhoven RF, Hahn BH, Tsokos GC, Lipsky P, Fei K, Gordon RM, Gregan I, Lo KH, Chevrier M, Rose S. Maintenance of Efficacy and Safety of Ustekinumab Through One Year in a Phase II Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Patients With Active Systemic Lupus Erythematosus. Arthritis Rheumatol. 2020 May;72(5):761-768. doi: 10.1002/art.41179. Epub 2020 Apr 1.
van Vollenhoven RF, Hahn BH, Tsokos GC, Wagner CL, Lipsky P, Touma Z, Werth VP, Gordon RM, Zhou B, Hsu B, Chevrier M, Triebel M, Jordan JL, Rose S. Efficacy and safety of ustekinumab, an IL-12 and IL-23 inhibitor, in patients with active systemic lupus erythematosus: results of a multicentre, double-blind, phase 2, randomised, controlled study. Lancet. 2018 Oct 13;392(10155):1330-1339. doi: 10.1016/S0140-6736(18)32167-6. Epub 2018 Sep 21.
FG001
Ustekinumab
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16. Participants who completed placebo controlled period (PCP) continued to receive ustekinumab 90 mg at Weeks 24, 32, and 40 followed by safety follow-up for 16 weeks after last study agent SC administration. Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
FG002
Placebo to Ustekinumab
Participants who received placebo matched to ustekinumab and completed PCP period in placebo group were crossed-over at Week 24 and received ustekinumab 90 mg SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration. Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
FG00042 subjects
FG00160 subjects
FG0020 subjects
COMPLETED
FG00033 subjects
FG00156 subjects
FG0020 subjects
NOT COMPLETED
FG0009 subjects
FG0014 subjects
FG0020 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0013 subjects
FG0020 subjects
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
Other
FG0001 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
Main Study: Week 24 to 56
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00156 subjects
FG00233 subjects
COMPLETED
FG0000 subjects
FG00153 subjects
FG00230 subjects
NOT COMPLETED
FG0000 subjects
FG0013 subjects
FG0023 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0021 subjects
Lack of Efficacy
FG000
Study Extension (Week 56 to Week 120)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00129 subjectsWho met study extension inclusion criteria received open-label ustekinumab SC through Week 104.
FG00217 subjectsWho met study extension inclusion criteria received open-label ustekinumab SC through Week 104.
COMPLETED
FG0000 subjects
FG00124 subjects
FG00214 subjects
NOT COMPLETED
FG0000 subjects
FG0015 subjects
FG0023 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0013 subjects
FG0020 subjects
Lack of Efficacy
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo - Ustekinumab
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16. At Week 24, participants who completed were crossed-over to receive ustekinumab 90 milligram (mg) SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration.
BG001
Ustekinumab
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16. Participants who completed placebo controlled period (PCP) continued to receive ustekinumab 90 mg at Weeks 24, 32, and 40 followed by safety follow-up for 16 weeks after last study agent SC administration. Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00042
BG00160
BG002102
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00043.1± 11.03
BG00140± 11.95
BG00241.3± 11.62
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00035
BG00158
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00012
BG00120
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0006
BG0018
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Argentina
Title
Measurements
BG0004
BG0018
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24
SRI-4 response was defined as greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA). Composite response is defined as SRI-4 response in participants who do not meet treatment failure criteria. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well (0)-very poor (10).
Full analysis set (FAS) included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
OG001
Ustekinumab
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16.
Units
Counts
Participants
OG00042
OG00160
Title
Denominators
Categories
Title
Measurements
OG00033.3
OG00161.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.0057
Odds Ratio (OR)
3.28
2-Sided
95
1.41
7.63
Superiority
Secondary
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) Score at Week 24
The SLEDAI-2K is an established, validated SLE activity index. It is based on the presence of 24 features in 9 organ systems and measures disease activity in SLE patients in the previous 30 days. It is weighted according to the feature. Features are scored by the assessing physician if present within the last 30 days with more severe features having higher scores, and then simply added to determine the total SLEDAI 2K score, which ranges from 0 to 105, with higher scores representing increased disease activity.
FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
OG001
Ustekinumab
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16.
Secondary
Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Score at Week 24
PGA was recorded on a visual analogue scale (VAS; 0.0 to 10.0 centimeter [cm]). The scale for the physician's assessment ranges for 'no lupus activity' (0.0) to 'extremely active lupus' (10.0).
FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
OG001
Ustekinumab
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16.
Units
Counts
Participants
Secondary
Number of Participants With BILAG-based Combined Lupus Assessment (BICLA) Response at Week 24
BICLA response defined as participants meeting following criteria: 1. BILAG improvement (all BILAG A scores at baseline improved to either B, C or D and all BILAG B scores at baseline improved to C or D and no worsening in disease activity defined as no new BILAG A scores and <= 1 new BILAG B score) and 2. no worsening of total SLEDAI-2K from baseline 3. < 1 cm increase in PGA and 4. no treatment failure criteria met. BILAG: assesses disease extent, severity (range: A [severe] to E [no disease]). SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PGA: assesses worsening in participant's general health status (0.0= 'no lupus activity' to 10.0 = 'extremely active lupus').
FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo.
Posted
Count of Participants
Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
OG001
Ustekinumab
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16.
Secondary
Change From Baseline in Number of Joints With Pain and Signs of Inflammation at Week 24
Change from baseline in number of joints (active joint) with pain and signs of inflammation (tenderness, swelling or effusion) for participants with at least 2 affected joints at baseline were reported. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion).
FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Population included participants with at least 2 affected joints at baseline (2 or more affected joints).
Posted
Mean
Standard Deviation
Joints
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
OG001
Ustekinumab
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Weeks 8 and 16.
Units
Counts
Time Frame
Screening up to Week 120
Description
Safety analysis set was defined as the set of all randomized participants who have received at least 1 dose (partial or complete, intravenously [IV] or subcutaneously [SC]) of ustekinumab or placebo.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (Up to Week 24)
Participants received placebo matched to ustekinumab intravenously (IV) at Week 0 then followed by placebo subcutaneously (SC) at Week 8 and 16.
0
42
4
42
25
42
EG001
Ustekinumab (Up to Week 24)
Participants received an initial body weight range based IV dose approximating 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by 90 mg SC administered every 8 weeks (q8w) at Week 8 and 16.
0
60
5
60
30
60
EG002
Placebo to Ustekinumab (Week 24 to 56)
Participants who received placebo matched to ustekinumab and completed placebo controlled period (PCP) in placebo group were crossed-over at Week 24 and received ustekinumab 90 milligram (mg) SC at Weeks 24, 32, and 40 followed by safety follow-up through Week 56 in a blinded fashion for 16 weeks after last study agent SC administration.
0
33
5
33
21
33
EG003
Ustekinumab (Week 24 to 56)
Participants who were assigned to Ustekinumab treatment and who completed PCP continued to receive ustekinumab 90 mg SC at Weeks 24, 32, and 40 followed by safety follow up for 16 weeks after last study agent SC administration.
0
56
7
56
34
56
EG004
Placebo to Ustekinumab (Week 56 to 120)
Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
0
17
1
17
8
17
EG005
Ustekinumab (Week 56 to 120)
Per the amended study design, open-label ustekinumab 90 mg q8w SC administration will continue to be provided through Week 104 (study extension) to eligible participants followed by safety follow-up through Week 120.
0
29
4
29
22
29
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypochromic Anaemia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG0030 affected56 at risk
EG004
Coronary Artery Occlusion
Cardiac disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Gastric Ulcer
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0011 affected60 at risk
EG0020 affected33 at risk
EG003
Pyrexia
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0011 affected60 at risk
EG0020 affected33 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0011 affected60 at risk
EG0020 affected33 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Neutropenic Sepsis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0011 affected60 at risk
EG0020 affected33 at risk
EG003
Salmonella Sepsis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Stenotrophomonas Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Systemic Lupus Erythematosus
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Ischaemic Stroke
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0011 affected60 at risk
EG0020 affected33 at risk
EG003
Posterior Reversible Encephalopathy Syndrome
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Glomerulonephritis
Renal and urinary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Lupus Nephritis
Renal and urinary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Raynaud's Phenomenon
Vascular disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0022 affected33 at risk
EG0031 affected56 at risk
EG0040 affected17 at risk
EG0051 affected29 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected42 at risk
EG0010 affected60 at risk
EG0022 affected33 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected42 at risk
EG0011 affected60 at risk
EG0022 affected33 at risk
EG003
Dry Eye
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0022 affected33 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0014 affected60 at risk
EG0023 affected33 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected42 at risk
EG0013 affected60 at risk
EG0021 affected33 at risk
EG003
Fatigue
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0012 affected60 at risk
EG0022 affected33 at risk
EG003
Pyrexia
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0013 affected60 at risk
EG0020 affected33 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0012 affected60 at risk
EG0021 affected33 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected42 at risk
EG0011 affected60 at risk
EG0023 affected33 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0003 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Infected Bite
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0003 affected42 at risk
EG0016 affected60 at risk
EG0022 affected33 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0013 affected60 at risk
EG0021 affected33 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0013 affected60 at risk
EG0020 affected33 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Tinea Versicolour
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Tooth Abscess
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0011 affected60 at risk
EG0021 affected33 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0011 affected60 at risk
EG0022 affected33 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0009 affected42 at risk
EG0015 affected60 at risk
EG0023 affected33 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0004 affected42 at risk
EG0016 affected60 at risk
EG0026 affected33 at risk
EG003
Vulvitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected42 at risk
EG0011 affected60 at risk
EG0021 affected33 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected42 at risk
EG0012 affected60 at risk
EG0021 affected33 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0003 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected42 at risk
EG0012 affected60 at risk
EG0020 affected33 at risk
EG003
Systemic Lupus Erythematosus
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected42 at risk
EG0013 affected60 at risk
EG0022 affected33 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0005 affected42 at risk
EG0014 affected60 at risk
EG0021 affected33 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected42 at risk
EG0010 affected60 at risk
EG0020 affected33 at risk
EG003
Menstruation Irregular
Reproductive system and breast disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Ovarian Cyst
Reproductive system and breast disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0022 affected33 at risk
EG003
Actinic Keratosis
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Peripheral Arterial Occlusive Disease
Vascular disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected42 at risk
EG0010 affected60 at risk
EG0021 affected33 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication o r presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.