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A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03161483
Recruitment Status : Completed
First Posted : May 19, 2017
Results First Posted : February 18, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Interventions Drug: CC-220
Other: Placebo
Enrollment 289
Recruitment Details  
Pre-assignment Details Placebo-controlled phase: 289 participants were randomized and 288 treated
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description Placebo-matching treatment once a day Participants dosed with CC-220 at 0.15 mg once a day Participants dosed with CC-220 at 0.30 mg once a day Participants dosed with CC-220 at 0.45 mg once a day
Period Title: Overall Study
Started [1] 83 42 82 81
Completed [2] 73 39 62 73
Not Completed 10 3 20 8
Reason Not Completed
Death             1             0             0             0
Adverse Event             5             1             11             2
Pregnancy             1             0             0             0
Lack of Efficacy             0             0             1             0
Withdrawal by Subject             2             2             6             5
Lost to Follow-up             0             0             1             0
Protocol Violation             0             0             1             0
Other reasons             1             0             0             1
[1]
Started = Entered placebo-controlled phase
[2]
Completed = Finished placebo-controlled phase
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD Total
Hide Arm/Group Description Placebo-matching treatment once a day Participants dosed with CC-220 at 0.15 mg once a day Participants dosed with CC-220 at 0.30 mg once a day Participants dosed with CC-220 at 0.45 mg once a day Total of all reporting groups
Overall Number of Baseline Participants 83 42 82 81 288
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 42 participants 82 participants 81 participants 288 participants
43.4  (13.3) 43.8  (13.0) 44.7  (13.7) 46.4  (11.2) 44.7  (12.8)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 42 participants 82 participants 81 participants 288 participants
< 40 years old
33
  39.8%
15
  35.7%
31
  37.8%
24
  29.6%
103
  35.8%
>= 40 to <= 50
26
  31.3%
15
  35.7%
21
  25.6%
28
  34.6%
90
  31.3%
> 50 to < 65
19
  22.9%
10
  23.8%
24
  29.3%
24
  29.6%
77
  26.7%
>= 65
5
   6.0%
2
   4.8%
6
   7.3%
5
   6.2%
18
   6.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 42 participants 82 participants 81 participants 288 participants
Female
81
  97.6%
41
  97.6%
77
  93.9%
79
  97.5%
278
  96.5%
Male
2
   2.4%
1
   2.4%
5
   6.1%
2
   2.5%
10
   3.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 42 participants 82 participants 81 participants 288 participants
Hispanic or Latino
41
  49.4%
21
  50.0%
46
  56.1%
33
  40.7%
141
  49.0%
Not Hispanic or Latino
42
  50.6%
21
  50.0%
36
  43.9%
48
  59.3%
147
  51.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 42 participants 82 participants 81 participants 288 participants
American Indian or Alaska Native
2
   2.4%
5
  11.9%
1
   1.2%
5
   6.2%
13
   4.5%
Asian
0
   0.0%
0
   0.0%
1
   1.2%
0
   0.0%
1
   0.3%
Black or African American
7
   8.4%
3
   7.1%
6
   7.3%
5
   6.2%
21
   7.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
60
  72.3%
29
  69.0%
59
  72.0%
60
  74.1%
208
  72.2%
Not collected or reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other
14
  16.9%
5
  11.9%
15
  18.3%
11
  13.6%
45
  15.6%
1.Primary Outcome
Title Number of Participants Who Achieve SLE Responder Index (SRI) (4) Response
Hide Description

The primary objective is to evaluate the clinical efficacy of three doses of CC-220 (0.45 mg once per day [QD], 0.3 mg QD or 0.15 mg QD) compared to placebo, for the treatment of active systemic lupus erythematosus (SLE) using the SLE Responder Index at Week 24

Composite endpoint SRI(4), defined by the following criteria:

  • Reduction from Baseline of ≥ 4 points in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K score and
  • No new one or more British Isles Lupus Assessment Group (BILAG) A or new (excludes A to B) 2 or more BILAG B items compared to Baseline using BILAG 2004 Index and
  • No worsening from Baseline defined by an increase of < 0.30 points from Baseline on a Physician's Global Assessment (PGA) visual analog scale (VAS) from 0-3
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis based on Intent-to-treat (ITT) Population (all randomized participants who received at least one dose of investigational product) and nonresponder imputation (NRI). Participants with insufficient data for response determination at the given time point are considered nonresponders.
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description:
Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 83 42 82 81
Measure Type: Number
Unit of Measure: Number of participants
29 20 33 44
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.15 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 11.4
Confidence Interval (2-Sided) 95%
-6.57 to 29.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.512
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 5.0
Confidence Interval (2-Sided) 95%
-9.77 to 19.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.45 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 19.4
Confidence Interval (2-Sided) 95%
4.12 to 33.42
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With SLEDAI 2K Score Improvement of ≥ 4 Points From Baseline
Hide Description The SLEDAI 2K score measures disease activity through assessment of 24 lupus manifestations using a weighted score of 1 to 8 points. A manifestation is recorded if it is present over the previous 30 days regardless of severity or whether it has improved or worsened. A SLEDAI 2K score of 3 to 4 points is representative of active disease and a decrease of 1 to 2 points is considered clinically meaningful.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants with insufficient data for response determination at the given time point are considered nonresponders.
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description:
Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 83 42 82 81
Measure Type: Number
Unit of Measure: Number of participants
30 20 35 45
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.15 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 10.3
Confidence Interval (2-Sided) 95%
-7.66 to 27.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.399
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 6.5
Confidence Interval (2-Sided) 95%
-8.45 to 21.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.45 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 19.3
Confidence Interval (2-Sided) 95%
4.01 to 33.36
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With a ≥ 50% Reduction in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score From Baseline, in Participants With Baseline CLASI Activity Score ≥ 10
Hide Description The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and non-scarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with Baseline CLASI activity score ≥ 10
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description:
Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 16 11 18 19
Measure Type: Number
Unit of Measure: Number of participants
8 8 8 13
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.15 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.446
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 24.0
Confidence Interval (2-Sided) 95%
-12.38 to 53.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 5.3
Confidence Interval (2-Sided) 95%
-27.64 to 39.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.45 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.488
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 14.2
Confidence Interval (2-Sided) 95%
-19.54 to 44.48
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With no New Organ System Affected as Defined by 1 or More BILAG A or New (Excludes A to B) 2 or More BILAG B Items Compared to Baseline Using BILAG 2004 Index
Hide Description The BILAG 2004 is a composite index that is based on the Classic BILAG index. It is a clinical measure of lupus disease activity. This tool assesses the changing severity of clinical manifestations of SLE using an ordinal scale scoring system that contain 9 systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and hematological). Activity in each organ system is scored as: A=most active disease; B=intermediate activity; C=mild, stable disease; D=previous involvement, currently inactive; E=no previous activity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description:
Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 83 42 82 81
Measure Type: Number
Unit of Measure: Number of participants
65 38 59 70
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.15 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 12.4
Confidence Interval (2-Sided) 95%
-2.74 to 24.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.434
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value -5.3
Confidence Interval (2-Sided) 95%
-18.43 to 8.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.45 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.182
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 8.0
Confidence Interval (2-Sided) 95%
-3.88 to 19.65
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With no Worsening (Increase of < 0.30 Points From Baseline) in PGA Compared to Baseline
Hide Description The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description:
Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 83 42 82 81
Measure Type: Number
Unit of Measure: Percentage of participants
78.3 90.5 73.2 85.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.15 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 12.1
Confidence Interval (2-Sided) 95%
-2.98 to 23.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.521
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value -4.3
Confidence Interval (2-Sided) 95%
-17.36 to 8.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.45 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.267
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 6.8
Confidence Interval (2-Sided) 95%
-5.24 to 18.55
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Change From Baseline in Swollen Joint Count in Participants With ≥ 2 Swollen Joints at Baseline
Hide Description

Joint tenderness and swelling will be noted as "present" or "absent," with no quantitation of severity using a 28- joint count.

Note: Data presented is Adjusted mean data.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Subjects with >=2 Swollen Joints, with a baseline value and a value at the time point.
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description:
Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 62 33 54 56
Mean (95% Confidence Interval)
Unit of Measure: swollen joints
-6.7
(-7.2 to -6.2)
-6.0
(-6.7 to -5.3)
-6.0
(-6.7 to -5.2)
-6.6
(-7.1 to -6.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.15 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.116
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted mean
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-0.2 to 1.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted mean
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-0.1 to 1.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.45 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.881
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted mean
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.6 to 0.8
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Change From Baseline in Tender Joint Count in Participants With ≥ 2 Tender Joints at Baseline
Hide Description

Joint tenderness and swelling will be noted as "present" or "absent," with no quantitation of severity using a 28- joint count.

Note: Data presented is Adjusted mean data.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Participants with >=2 Tender Joints, with a baseline value and a value at the time point.
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description:
Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 62 33 54 56
Mean (95% Confidence Interval)
Unit of Measure: tender joints
-7.9
(-8.8 to -7.0)
-6.8
(-8.1 to -5.6)
-6.7
(-7.7 to -5.6)
-7.6
(-8.5 to -6.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.15 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted mean
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-0.4 to 2.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted mean
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.0 to 2.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.45 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.621
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted mean
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.0 to 1.6
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Change From Baseline in PGA Score
Hide Description The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with a baseline value and a value at the time point.
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description:
Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 66 38 63 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.803  (0.605) -0.805  (0.528) -0.819  (0.629) -0.883  (0.546)
9.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
Hide Description

The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total FACIT-Fatigue score ranges from 0 to 52.

Note: Data presented is Adjusted mean data.

Time Frame Week 24
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ITT population; participants with a baseline value and a value at the time point
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
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Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 67 38 60 69
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
3.8
(1.6 to 6.0)
2.7
(-0.3 to 5.6)
3.1
(0.9 to 5.4)
5.2
(3.0 to 7.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.15 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.546
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted mean
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-4.7 to 2.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.681
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted mean
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-3.7 to 2.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.45 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.350
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted mean
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-1.6 to 4.4
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Corticosteroid Reduction
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  • The percentage of participants with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to ≤ 7.5 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24
  • The percentage of participants with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to < 10 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24
Time Frame Week 24
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ITT Population; Participants with Baseline OCS Dose >= 10 mg/day

Participants with insufficient data for response determination at the given time point are considered nonresponders.

Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
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Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 31 17 30 32
Measure Type: Number
Unit of Measure: Percentage of participants
Week 24, <= 7.5 mg/day 3.2 0.0 3.3 0.0
Week 24, < 10 mg/day 6.5 0.0 3.3 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments <= 7.5 mg/day
Statistical Test of Hypothesis P-Value >0.999
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-15.13 to 15.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments < 10 mg/day
Statistical Test of Hypothesis P-Value >0.999
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified difference
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-17.74 to 13.00
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percent Change From Baseline in Corticosteroid Reduction
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Percent change from Baseline in oral corticosteroid (OCS) dose in subjects with prednisone or equivalent ≥ 10 mg/day at Baseline

Note: Data presented is Adjusted mean data.

Time Frame Week 24
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ITT Population; Participants with the Baseline OCS Dose >= 10 mg/day, with a baseline value and a value at the time point.
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description:
Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 26 17 25 30
Mean (95% Confidence Interval)
Unit of Measure: percent change from baseline
-7.9
(-13.6 to -2.2)
-5.1
(-11.9 to 1.6)
-3.8
(-9.5 to 2.0)
-1.4
(-6.4 to 3.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.15 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.535
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted means
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
-6.0 to 11.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.309
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted means
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
-3.9 to 12.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO QD, 0.45 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method longitudinal data analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in adjusted means
Estimated Value 6.5
Confidence Interval (2-Sided) 95%
-1.0 to 14.1
Estimation Comments [Not Specified]
12.Secondary Outcome
Title The Total Corticosteroid Dose From Baseline Through Week 24
Hide Description Standardized total oral corticosteroid (OCS) dose.
Time Frame Through Week 24
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ITT population
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description:
Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 83 42 82 81
Mean (Standard Deviation)
Unit of Measure: mg
1139.7  (916.9) 1101.9  (827.1) 1071.8  (965.0) 1105.5  (969.3)
13.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description Number of participants who experienced a TEAE during the course of the study
Time Frame from first dose to 28 days post-last dose through Week 24 (placebo-controlled phase), approximately 28 weeks total
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All treated participants
Arm/Group Title PBO QD 0.15 mg QD 0.30 mg QD 0.45 mg QD
Hide Arm/Group Description:
Placebo-matching treatment once a day
Participants dosed with CC-220 at 0.15 mg once a day
Participants dosed with CC-220 at 0.30 mg once a day
Participants dosed with CC-220 at 0.45 mg once a day
Overall Number of Participants Analyzed 83 42 82 81
Measure Type: Number
Unit of Measure: Number of participants
Any TEAE 54 31 64 63
Any Drug-related TEAE 24 14 36 32
Any Serious TEAE 7 3 4 6
Any Severe TEAE 5 3 4 1
Any TEAE Leading to Drug Interruption 15 10 14 23
Any TEAE Leading to Drug Withdrawal 6 2 11 4
Any TEAE Leading to Death 1 0 0 0
Time Frame From first dose to 28 days post-last dose of the placebo-controlled phase (through Week 24), approximately 28 weeks total.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PBO Controlled - PBO PBO Controlled - 0.15 mg QD PBO Controlled - 0.30 mg QD PBO Controlled - 0.45 mg QD
Hide Arm/Group Description Placebo-matching treatment once a day Participants dosed with CC-220 at 0.15 mg once a day Participants dosed with CC-220 at 0.30 mg once a day Participants dosed with CC-220 at 0.45 mg once a day
All-Cause Mortality
PBO Controlled - PBO PBO Controlled - 0.15 mg QD PBO Controlled - 0.30 mg QD PBO Controlled - 0.45 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/83 (1.20%)   0/42 (0.00%)   0/82 (0.00%)   0/81 (0.00%) 
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PBO Controlled - PBO PBO Controlled - 0.15 mg QD PBO Controlled - 0.30 mg QD PBO Controlled - 0.45 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/83 (8.43%)   3/42 (7.14%)   4/82 (4.88%)   6/81 (7.41%) 
Cardiac disorders         
Cardiac tamponade  1  0/83 (0.00%)  1/42 (2.38%)  0/82 (0.00%)  0/81 (0.00%) 
Pericarditis  1  0/83 (0.00%)  1/42 (2.38%)  0/82 (0.00%)  0/81 (0.00%) 
Gastrointestinal disorders         
Diverticular perforation  1  1/83 (1.20%)  0/42 (0.00%)  0/82 (0.00%)  0/81 (0.00%) 
General disorders         
Implant site pain  1  0/83 (0.00%)  1/42 (2.38%)  0/82 (0.00%)  0/81 (0.00%) 
Influenza like illness  1  0/83 (0.00%)  0/42 (0.00%)  0/82 (0.00%)  1/81 (1.23%) 
Infections and infestations         
Escherichia urinary tract infection  1  1/83 (1.20%)  0/42 (0.00%)  0/82 (0.00%)  0/81 (0.00%) 
Gastroenteritis viral  1  0/83 (0.00%)  0/42 (0.00%)  0/82 (0.00%)  1/81 (1.23%) 
Pneumonia  1  0/83 (0.00%)  0/42 (0.00%)  0/82 (0.00%)  1/81 (1.23%) 
Urinary tract infection enterococcal  1  1/83 (1.20%)  0/42 (0.00%)  0/82 (0.00%)  0/81 (0.00%) 
Injury, poisoning and procedural complications         
Acetabulum fracture  1  0/83 (0.00%)  0/42 (0.00%)  1/82 (1.22%)  0/81 (0.00%) 
Forearm fracture  1  0/83 (0.00%)  0/42 (0.00%)  0/82 (0.00%)  1/81 (1.23%) 
Lower limb fracture  1  0/83 (0.00%)  1/42 (2.38%)  0/82 (0.00%)  0/81 (0.00%) 
Radius fracture  1  0/83 (0.00%)  0/42 (0.00%)  0/82 (0.00%)  1/81 (1.23%) 
Musculoskeletal and connective tissue disorders         
Systemic lupus erythematosus  1  3/83 (3.61%)  0/42 (0.00%)  0/82 (0.00%)  0/81 (0.00%) 
Nervous system disorders         
Brain stem infarction  1  0/83 (0.00%)  0/42 (0.00%)  1/82 (1.22%)  0/81 (0.00%) 
Encephalopathy  1  1/83 (1.20%)  0/42 (0.00%)  0/82 (0.00%)  0/81 (0.00%) 
Hemiparesis  1  0/83 (0.00%)  0/42 (0.00%)  1/82 (1.22%)  0/81 (0.00%) 
Reproductive system and breast disorders         
Endometriosis  1  1/83 (1.20%)  0/42 (0.00%)  0/82 (0.00%)  0/81 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/83 (0.00%)  0/42 (0.00%)  0/82 (0.00%)  1/81 (1.23%) 
Epistaxis  1  0/83 (0.00%)  0/42 (0.00%)  0/82 (0.00%)  1/81 (1.23%) 
Hypoxia  1  0/83 (0.00%)  0/42 (0.00%)  1/82 (1.22%)  0/81 (0.00%) 
Laryngeal oedema  1  1/83 (1.20%)  0/42 (0.00%)  0/82 (0.00%)  0/81 (0.00%) 
Pulmonary embolism  1  1/83 (1.20%)  0/42 (0.00%)  0/82 (0.00%)  0/81 (0.00%) 
Vascular disorders         
Deep vein thrombosis  1  1/83 (1.20%)  0/42 (0.00%)  1/82 (1.22%)  0/81 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PBO Controlled - PBO PBO Controlled - 0.15 mg QD PBO Controlled - 0.30 mg QD PBO Controlled - 0.45 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/83 (22.89%)   16/42 (38.10%)   30/82 (36.59%)   34/81 (41.98%) 
Blood and lymphatic system disorders         
Leukopenia  1  1/83 (1.20%)  1/42 (2.38%)  3/82 (3.66%)  5/81 (6.17%) 
Neutropenia  1  2/83 (2.41%)  2/42 (4.76%)  6/82 (7.32%)  9/81 (11.11%) 
Gastrointestinal disorders         
Diarrhoea  1  0/83 (0.00%)  3/42 (7.14%)  2/82 (2.44%)  3/81 (3.70%) 
Infections and infestations         
Influenza  1  3/83 (3.61%)  3/42 (7.14%)  4/82 (4.88%)  5/81 (6.17%) 
Nasopharyngitis  1  1/83 (1.20%)  3/42 (7.14%)  1/82 (1.22%)  7/81 (8.64%) 
Sinusitis  1  1/83 (1.20%)  1/42 (2.38%)  0/82 (0.00%)  5/81 (6.17%) 
Upper respiratory tract infection  1  4/83 (4.82%)  3/42 (7.14%)  7/82 (8.54%)  10/81 (12.35%) 
Urinary tract infection  1  3/83 (3.61%)  2/42 (4.76%)  13/82 (15.85%)  8/81 (9.88%) 
Nervous system disorders         
Headache  1  5/83 (6.02%)  2/42 (4.76%)  0/82 (0.00%)  0/81 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by 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.
Results Point of Contact
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Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please email:
EMail: Clinical.Trials@bms.com
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03161483    
Other Study ID Numbers: CC-220-SLE-002
U1111-1195-7804 ( Registry Identifier: WHO )
First Submitted: May 18, 2017
First Posted: May 19, 2017
Results First Submitted: January 19, 2021
Results First Posted: February 18, 2021
Last Update Posted: September 28, 2021