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Trial record 26 of 907 for:    Lupus

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT02349061
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : June 12, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Interventions Drug: Ustekinumab IV
Drug: Placebo Infusion
Drug: Placebo SC
Drug: Ustekinumab SC
Other: Concomitant Medication
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Ustekinumab
Hide Arm/Group Description Participants received placebo IV at Week 0 followed by placebo SC at Weeks 8 and 16. Participants were continued to stable concomitant treatment through Week 24. Participants received weight-range based dosing of 6 milligram per kilogram (mg/kg) of ustekinumab IV at Week 0 followed by ustekinumab 90 mg SC at weeks 8 and 16. Participants were continued to stable concomitant treatment through Week 24.
Period Title: Overall Study
Started 42 60
Completed 33 56
Not Completed 9 4
Reason Not Completed
Adverse Event             4             3
Lack of Efficacy             1             0
Physician Decision             1             0
Other             3             1
Arm/Group Title Placebo Ustekinumab Total
Hide Arm/Group Description Participants received placebo IV at Week 0 followed by placebo SC at Weeks 8 and 16. Participants were continued to stable concomitant treatment through Week 24. Participants received weight-range based dosing of 6 milligram per kilogram (mg/kg) of ustekinumab IV at Week 0 followed by ustekinumab 90 mg SC at weeks 8 and 16. Participants were continued to stable concomitant treatment through Week 24. Total of all reporting groups
Overall Number of Baseline Participants 42 60 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 60 participants 102 participants
43.1  (11.03) 40  (11.95) 41.3  (11.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 60 participants 102 participants
Female
35
  83.3%
58
  96.7%
93
  91.2%
Male
7
  16.7%
2
   3.3%
9
   8.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 60 participants 102 participants
Hispanic or Latino
12
  28.6%
20
  33.3%
32
  31.4%
Not Hispanic or Latino
30
  71.4%
40
  66.7%
70
  68.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 60 participants 102 participants
American Indian or Alaska Native
0
   0.0%
1
   1.7%
1
   1.0%
Asian
6
  14.3%
8
  13.3%
14
  13.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   7.1%
4
   6.7%
7
   6.9%
White
28
  66.7%
42
  70.0%
70
  68.6%
More than one race
5
  11.9%
4
   6.7%
9
   8.8%
Unknown or Not Reported
0
   0.0%
1
   1.7%
1
   1.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 60 participants 102 participants
Asian
6
  14.3%
8
  13.3%
14
  13.7%
Black or African American
3
   7.1%
4
   6.7%
7
   6.9%
Hispanic or Latino
7
  16.7%
13
  21.7%
20
  19.6%
Other
5
  11.9%
6
  10.0%
11
  10.8%
White Non-Hispanic
21
  50.0%
29
  48.3%
50
  49.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 60 participants 102 participants
Argentina
4
   9.5%
8
  13.3%
12
  11.8%
Australia
2
   4.8%
3
   5.0%
5
   4.9%
Germany
2
   4.8%
3
   5.0%
5
   4.9%
Hungary
4
   9.5%
4
   6.7%
8
   7.8%
Mexico
6
  14.3%
5
   8.3%
11
  10.8%
Poland
7
  16.7%
12
  20.0%
19
  18.6%
Spain
5
  11.9%
7
  11.7%
12
  11.8%
Taiwan, Province Of China
6
  14.3%
7
  11.7%
13
  12.7%
United States
6
  14.3%
11
  18.3%
17
  16.7%
1.Primary Outcome
Title Percentage of Participants With a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24
Hide Description 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).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who received at least one dose (partial or complete, intravenously [IV] or subcutaneously [SC]) of ustekinumab or placebo.
Arm/Group Title Placebo Ustekinumab
Hide Arm/Group Description:
Participants received placebo IV at Week 0 followed by placebo SC at Weeks 8 and 16. Participants were continued to stable concomitant treatment through Week 24.
Participants received weight-range based dosing of 6 milligram per kilogram (mg/kg) of ustekinumab IV at Week 0 followed by ustekinumab 90 mg SC at weeks 8 and 16. Participants were continued to stable concomitant treatment through Week 24.
Overall Number of Participants Analyzed 42 60
Measure Type: Number
Unit of Measure: Percentage of participants
33.3 61.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0057
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.28
Confidence Interval (2-Sided) 95%
1.41 to 7.63
Estimation Comments [Not Specified]
Time Frame Screening up to Week 24
Adverse Event Reporting Description Safety analysis set was defined as the set of all randomized subjects who have received at least 1 dose (partial or complete, intravenously [IV] or subcutaneously [SC]) of ustekinumab or placebo.
 
Arm/Group Title Placebo Ustekinumab
Hide Arm/Group Description Participants received placebo IV at Week 0 followed by placebo SC at Weeks 8 and 16. Participants were continued to stable concomitant treatment through Week 24. Participants received weight-range based dosing of 6 milligram per kilogram (mg/kg) of ustekinumab IV at Week 0 followed by ustekinumab 90 mg SC at weeks 8 and 16. Participants were continued to stable concomitant treatment through Week 24.
All-Cause Mortality
Placebo Ustekinumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/60 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ustekinumab
Affected / at Risk (%) Affected / at Risk (%)
Total   4/42 (9.52%)   5/60 (8.33%) 
Gastrointestinal disorders     
Gastric Ulcer * 1  1/42 (2.38%)  0/60 (0.00%) 
Pancreatitis Acute * 1  0/42 (0.00%)  1/60 (1.67%) 
General disorders     
Pyrexia * 1  1/42 (2.38%)  0/60 (0.00%) 
Immune system disorders     
Anaphylactic Reaction * 1  0/42 (0.00%)  1/60 (1.67%) 
Infections and infestations     
Bronchitis * 1  0/42 (0.00%)  1/60 (1.67%) 
Pneumonia * 1  0/42 (0.00%)  1/60 (1.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Keratoacanthoma * 1  1/42 (2.38%)  0/60 (0.00%) 
Nervous system disorders     
Ischaemic Stroke * 1  0/42 (0.00%)  1/60 (1.67%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  1/42 (2.38%)  0/60 (0.00%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Ustekinumab
Affected / at Risk (%) Affected / at Risk (%)
Total   24/42 (57.14%)   27/60 (45.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  0/42 (0.00%)  4/60 (6.67%) 
Nausea * 1  2/42 (4.76%)  3/60 (5.00%) 
General disorders     
Pyrexia * 1  0/42 (0.00%)  3/60 (5.00%) 
Infections and infestations     
Gastroenteritis Viral * 1  3/42 (7.14%)  0/60 (0.00%) 
Nasopharyngitis * 1  3/42 (7.14%)  6/60 (10.00%) 
Pharyngitis * 1  0/42 (0.00%)  3/60 (5.00%) 
Pharyngotonsillitis * 1  0/42 (0.00%)  3/60 (5.00%) 
Upper Respiratory Tract Infection * 1  9/42 (21.43%)  5/60 (8.33%) 
Urinary Tract Infection * 1  5/42 (11.90%)  6/60 (10.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/42 (7.14%)  0/60 (0.00%) 
Systemic Lupus Erythematosus * 1  2/42 (4.76%)  3/60 (5.00%) 
Nervous system disorders     
Headache * 1  5/42 (11.90%)  4/60 (6.67%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Clinical Development
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: NCT02349061     History of Changes
Other Study ID Numbers: CR106661
CNTO1275SLE2001 ( Other Identifier: Janssen Research & Development, LLC )
2014-005000-19 ( EudraCT Number )
First Submitted: January 23, 2015
First Posted: January 28, 2015
Results First Submitted: May 15, 2018
Results First Posted: June 12, 2018
Last Update Posted: April 11, 2019