Trial Outcomes & Findings for Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (NCT NCT02265744)
NCT ID: NCT02265744
Last Updated: 2019-10-07
Results Overview
The British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) is a measure of systemic lupus erythematosus (SLE) response. BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale \[VAS\]) compared to Baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
730 participants
Primary outcome timeframe
At Day 169
Results posted on
2019-10-07
Participant Flow
730 participants were enrolled and 349 were randomized. 3 were randomized but not treated.Of the 381 who were not randomized,3 had an adverse event, 16 withdrew consent, 1 was lost to follow-up, 339 did not meet study entry criteria and 22 due to other reasons.
Participant milestones
| Measure |
Experimental: 12.5mg SC BMS-931699 Weekly
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
Experimental: 12.5mg SC BMS-931699 Every Other Week
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
69
|
68
|
68
|
70
|
71
|
|
Overall Study
COMPLETED
|
49
|
53
|
51
|
47
|
58
|
|
Overall Study
NOT COMPLETED
|
20
|
15
|
17
|
23
|
13
|
Reasons for withdrawal
| Measure |
Experimental: 12.5mg SC BMS-931699 Weekly
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
Experimental: 12.5mg SC BMS-931699 Every Other Week
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
|---|---|---|---|---|---|
|
Overall Study
Poor/Non-compliance
|
1
|
1
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
2
|
0
|
|
Overall Study
Participant request to discontinue
|
2
|
2
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
8
|
4
|
9
|
8
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
3
|
4
|
5
|
|
Overall Study
Reason not provided by Investigator
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Administrative reason by sponsor
|
3
|
2
|
2
|
3
|
3
|
|
Overall Study
Subject no longer meets study criteria
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
2
|
1
|
1
|
0
|
Baseline Characteristics
All randomized and treated participants
Baseline characteristics by cohort
| Measure |
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Total
n=346 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.0 Years
n=69 Participants • All randomized and treated participants
|
39.1 Years
n=68 Participants • All randomized and treated participants
|
41.9 Years
n=68 Participants • All randomized and treated participants
|
38.0 Years
n=70 Participants • All randomized and treated participants
|
40.6 Years
n=71 Participants • All randomized and treated participants
|
40.2 Years
n=346 Participants • All randomized and treated participants
|
|
Sex/Gender, Customized
Females <= 50 years
|
47 Participants
n=67 Participants • All randomized and treated participants
|
57 Participants
n=66 Participants • All randomized and treated participants
|
47 Participants
n=65 Participants • All randomized and treated participants
|
55 Participants
n=66 Participants • All randomized and treated participants
|
51 Participants
n=65 Participants • All randomized and treated participants
|
257 Participants
n=329 Participants • All randomized and treated participants
|
|
Sex/Gender, Customized
Females > 50 years
|
20 Participants
n=67 Participants • All randomized and treated participants
|
9 Participants
n=66 Participants • All randomized and treated participants
|
18 Participants
n=65 Participants • All randomized and treated participants
|
11 Participants
n=66 Participants • All randomized and treated participants
|
14 Participants
n=65 Participants • All randomized and treated participants
|
72 Participants
n=329 Participants • All randomized and treated participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=69 Participants
|
66 Participants
n=68 Participants
|
65 Participants
n=68 Participants
|
66 Participants
n=70 Participants
|
65 Participants
n=71 Participants
|
329 Participants
n=346 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=69 Participants
|
2 Participants
n=68 Participants
|
3 Participants
n=68 Participants
|
4 Participants
n=70 Participants
|
6 Participants
n=71 Participants
|
17 Participants
n=346 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=69 Participants
|
2 Participants
n=68 Participants
|
3 Participants
n=68 Participants
|
6 Participants
n=70 Participants
|
3 Participants
n=71 Participants
|
17 Participants
n=346 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=69 Participants
|
9 Participants
n=68 Participants
|
9 Participants
n=68 Participants
|
7 Participants
n=70 Participants
|
5 Participants
n=71 Participants
|
36 Participants
n=346 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
60 Participants
n=69 Participants
|
57 Participants
n=68 Participants
|
56 Participants
n=68 Participants
|
57 Participants
n=70 Participants
|
63 Participants
n=71 Participants
|
293 Participants
n=346 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=69 Participants
|
0 Participants
n=68 Participants
|
1 Participants
n=68 Participants
|
1 Participants
n=70 Participants
|
0 Participants
n=71 Participants
|
2 Participants
n=346 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=69 Participants
|
7 Participants
n=68 Participants
|
10 Participants
n=68 Participants
|
9 Participants
n=70 Participants
|
8 Participants
n=71 Participants
|
43 Participants
n=346 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=69 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=346 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=69 Participants
|
9 Participants
n=68 Participants
|
7 Participants
n=68 Participants
|
7 Participants
n=70 Participants
|
12 Participants
n=71 Participants
|
41 Participants
n=346 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=69 Participants
|
46 Participants
n=68 Participants
|
41 Participants
n=68 Participants
|
43 Participants
n=70 Participants
|
41 Participants
n=71 Participants
|
209 Participants
n=346 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=69 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=346 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=69 Participants
|
6 Participants
n=68 Participants
|
9 Participants
n=68 Participants
|
10 Participants
n=70 Participants
|
10 Participants
n=71 Participants
|
51 Participants
n=346 Participants
|
PRIMARY outcome
Timeframe: At Day 169Population: All Randomized and Treated participants
The British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) is a measure of systemic lupus erythematosus (SLE) response. BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale \[VAS\]) compared to Baseline.
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169
|
63.2 Percentage of participants
Interval 53.6 to 72.9
|
57.4 Percentage of participants
Interval 47.5 to 67.2
|
58.6 Percentage of participants
Interval 48.9 to 68.3
|
59.2 Percentage of participants
Interval 49.6 to 68.8
|
59.4 Percentage of participants
Interval 49.7 to 69.1
|
SECONDARY outcome
Timeframe: At Day 169Population: All randomized and treated participants
SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale \[VAS\]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores. An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c). An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169
SRI (4)
|
48.5 Percentage of participants
Interval 38.6 to 58.5
|
39.7 Percentage of participants
Interval 29.9 to 49.5
|
44.3 Percentage of participants
Interval 34.5 to 54.1
|
49.3 Percentage of participants
Interval 39.5 to 59.1
|
55.1 Percentage of participants
Interval 45.2 to 64.9
|
|
Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169
SRI (5)
|
29.4 Percentage of participants
Interval 20.3 to 38.5
|
27.9 Percentage of participants
Interval 19.0 to 36.9
|
31.4 Percentage of participants
Interval 22.3 to 40.6
|
33.8 Percentage of participants
Interval 24.6 to 43.0
|
37.7 Percentage of participants
Interval 28.1 to 47.3
|
|
Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169
SRI (6)
|
26.5 Percentage of participants
Interval 17.7 to 35.3
|
27.9 Percentage of participants
Interval 19.0 to 36.9
|
31.4 Percentage of participants
Interval 22.3 to 40.6
|
33.8 Percentage of participants
Interval 24.6 to 43.0
|
37.7 Percentage of participants
Interval 28.1 to 47.3
|
SECONDARY outcome
Timeframe: At Day 85Population: All Randomized and Treated participants
SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale \[VAS\]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores. An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c). An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85
SRI (6)
|
30.9 Percentage of participants
Interval 21.7 to 40.1
|
25.0 Percentage of participants
Interval 16.4 to 33.6
|
31.4 Percentage of participants
Interval 22.3 to 40.6
|
26.8 Percentage of participants
Interval 18.1 to 35.4
|
29.0 Percentage of participants
Interval 20.0 to 38.0
|
|
Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85
SRI (4)
|
48.5 Percentage of participants
Interval 38.6 to 58.5
|
41.2 Percentage of participants
Interval 31.4 to 51.0
|
47.1 Percentage of participants
Interval 37.3 to 57.0
|
43.7 Percentage of participants
Interval 34.0 to 53.3
|
49.3 Percentage of participants
Interval 39.4 to 59.2
|
|
Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85
SRI (5)
|
32.4 Percentage of participants
Interval 23.0 to 41.7
|
25.0 Percentage of participants
Interval 16.4 to 33.6
|
31.4 Percentage of participants
Interval 22.3 to 40.6
|
28.2 Percentage of participants
Interval 19.4 to 36.9
|
29.0 Percentage of participants
Interval 20.0 to 38.0
|
SECONDARY outcome
Timeframe: At Day 85Population: All Randomized and Treated Participants
BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale \[VAS\]) compared to Baseline; No changes in concomitant medications according to the following criteria: No increase of or addition of a new immunosuppressant agent (azathioprine,mycophenolic acid/mycophenolate mofetil, methotrexate, anti-malarial, leflunomide) over baseline levels; No increase in corticosteroid dose above baseline level outside of those allowed per protocol.
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85
|
64.7 Percentage of participants
Interval 55.2 to 74.2
|
57.4 Percentage of participants
Interval 47.5 to 67.2
|
57.1 Percentage of participants
Interval 47.4 to 66.9
|
54.9 Percentage of participants
Interval 45.2 to 64.6
|
69.6 Percentage of participants
Interval 60.5 to 78.7
|
SECONDARY outcome
Timeframe: At Day 85 and Day 169Population: All Randomized and Treated Subjects
Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in CLASI Score at Day 85 and Day 169
Day 85
|
-3.20 Scores on a scale
Standard Deviation 4.718
|
-1.69 Scores on a scale
Standard Deviation 2.319
|
-1.82 Scores on a scale
Standard Deviation 4.515
|
-3.11 Scores on a scale
Standard Deviation 4.239
|
-2.31 Scores on a scale
Standard Deviation 3.107
|
|
Mean Change From Baseline in CLASI Score at Day 85 and Day 169
Day 169
|
-3.78 Scores on a scale
Standard Deviation 5.555
|
-2.47 Scores on a scale
Standard Deviation 2.824
|
-2.94 Scores on a scale
Standard Deviation 4.897
|
-3.57 Scores on a scale
Standard Deviation 4.177
|
-3.17 Scores on a scale
Standard Deviation 4.387
|
SECONDARY outcome
Timeframe: At Day 85 and Day 169Population: All randomized and treated participants
Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Percentage of Participants With an Improvement of >4 or a Decrease of >50% From Baseline in Their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Score
|
46.9 Percentage of participants
Interval 36.6 to 57.1
|
34.5 Percentage of participants
Interval 24.2 to 44.7
|
36.1 Percentage of participants
Interval 26.0 to 46.2
|
42.4 Percentage of participants
Interval 32.4 to 52.4
|
39.3 Percentage of participants
Interval 29.1 to 49.6
|
SECONDARY outcome
Timeframe: At baseline, Day 85 and Day 169Population: All Randomized and Treated Participants
Mean Change from Baseline Over Time; Measured by Disease Activity Score 28: A single score on a continuous scale (0-9.4). The level of RA disease activity can be interpreted as low (DAS28 \<=3.2),moderate (3.2 \< DAS28 \<=5.1), or as high disease activity (DAS28 \> 5.1)
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Change From Baseline in Arthritis, as Assessed by American College of Rheumatology (ACR) 28-joint Count of Tender and Swollen Joints on Day 85 and Day 169
|
-4.63 Scores on a scale
Standard Deviation 5.311
|
-4.75 Scores on a scale
Standard Deviation 4.985
|
-4.42 Scores on a scale
Standard Deviation 5.626
|
-3.84 Scores on a scale
Standard Deviation 4.922
|
-4.63 Scores on a scale
Standard Deviation 4.719
|
SECONDARY outcome
Timeframe: At baseline, Day 85 and Day 169Population: All randomized and treated participants
Overall British Isles Lupus Assessment Group-2004 score, BILAG Scores: A=Severe disease activity, B=Moderate disease activity, C=Mild disease, D=Inactive disease but previously affected, E=System never involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169
BILAG-2004 Score Day 85
|
-8.83 Score
Standard Deviation 7.749
|
-7.07 Score
Standard Deviation 7.299
|
-8.66 Score
Standard Deviation 6.598
|
-7.94 Score
Standard Deviation 8.008
|
-10.31 Score
Standard Deviation 7.480
|
|
Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169
BILAG-2004 Score Day 169
|
-10.46 Score
Standard Deviation 7.808
|
-8.98 Score
Standard Deviation 6.719
|
-9.73 Score
Standard Deviation 5.478
|
-9.78 Score
Standard Deviation 7.590
|
-11.50 Score
Standard Deviation 6.983
|
SECONDARY outcome
Timeframe: Up to one day prior to the first dose of long-term extension period or up to 42 days post last short-term dose date, which ever is earlierPopulation: All randomized and treated participants
Percent of participants requiring use of corticosteroids and mmunosuppressants use over time
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Cumulative Corticosteroid and Immunosuppressant Use
Corticosteroids: Oral
|
82.4 Percentage of participants
|
86.8 Percentage of participants
|
84.3 Percentage of participants
|
94.4 Percentage of participants
|
89.9 Percentage of participants
|
|
Cumulative Corticosteroid and Immunosuppressant Use
Corticosteroids: Oral inhalation
|
0 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Cumulative Corticosteroid and Immunosuppressant Use
Immunosuppressant
|
63.2 Percentage of participants
|
38.2 Percentage of participants
|
51.4 Percentage of participants
|
59.2 Percentage of participants
|
46.4 Percentage of participants
|
|
Cumulative Corticosteroid and Immunosuppressant Use
Immunosuppressant Azathioprine
|
29.4 Percentage of participants
|
14.7 Percentage of participants
|
28.6 Percentage of participants
|
33.8 Percentage of participants
|
23.2 Percentage of participants
|
|
Cumulative Corticosteroid and Immunosuppressant Use
Immunosuppressant Methotrexate
|
35.3 Percentage of participants
|
25.0 Percentage of participants
|
24.3 Percentage of participants
|
26.8 Percentage of participants
|
26.1 Percentage of participants
|
SECONDARY outcome
Timeframe: On or after the first dose date of short-term study medication and up to 42 days post last short-term dose date or up to the day prior to the first dose of long-term extension period, whichever is earlierPopulation: All treated subjects
Although there are no identified risks for BMS-931699, BMS has developed a list of events of special interest for the BMS-931699 program based on the known biologic class effects, the mechanism of action of BMS-931699, overall potential consequences of mmunosuppression, and preliminary data from unblinded clinical trials. Event categories of special interest for this study may include, but are not limited to: Infections, Autoimmunity, Malignancies, Injection-related reactions
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
Serious Adverse Events
|
5 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
Related SAEs
|
3 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
Related Adverse Events
|
30 Participants
|
29 Participants
|
19 Participants
|
19 Participants
|
33 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
AEs of Malignancies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
AEs of Infections and Infestations
|
41 Participants
|
35 Participants
|
39 Participants
|
30 Participants
|
38 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
AEs Leading to Discontinuation
|
5 Participants
|
9 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
Adverse Events of Autoimmunity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
Most Common Adverse Events
|
56 Participants
|
60 Participants
|
59 Participants
|
62 Participants
|
59 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
Adverse Events of Local Injection Reactions
|
8 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At Day 85 and Day 169Population: All Treated participants
HEART RATE (HR) Beats per min (BPM): HR \> 100 AND CHANGE FROM BASELINE \> 30 OR HR \< 55 AND CHANGE FROM BASELINE \< -15
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate
HEART RATE (BPM) SITTING
|
2.9 Percentage of participants
|
2.9 Percentage of participants
|
2.9 Percentage of participants
|
5.6 Percentage of participants
|
5.9 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate
HEART RATE (BPM) STANDING
|
4.3 Percentage of participants
|
7.4 Percentage of participants
|
7.1 Percentage of participants
|
5.7 Percentage of participants
|
5.9 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate
HEART RATE (BPM) SUPINE
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Day 85 and Day 169Population: All Treated participants
SYSTOLIC BLOOD PRESSURE (SYSBP) (MMHG); SYSBP \> 140 AND CHANGE FROM BASELINE \> 20 OR SYSBP \< 90 AND CHANGE FROM BASELINE \< -20; DIASTOLIC BLOOD PRESSURE (DIABP) \> 90 AND CHANGE FROM BASELINE \> 10 OR DIABP \< 55 AND CHANGE FROM BASELINE \< -10;
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure
SYSTOLIC BLOOD PRESSURE (MMHG) SITTING
|
11.6 Percentage of participants
|
10.3 Percentage of participants
|
10.0 Percentage of participants
|
15.5 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure
SYSTOLIC BLOOD PRESSURE (MMHG) STANDING
|
14.5 Percentage of participants
|
8.8 Percentage of participants
|
11.4 Percentage of participants
|
20.0 Percentage of participants
|
14.7 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure
SYSTOLIC BLOOD PRESSURE (MMHG) SUPINE
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure
DIASTOLIC BLOOD PRESSURE (MM HG) SITTING
|
26.1 Percentage of participants
|
11.8 Percentage of participants
|
17.1 Percentage of participants
|
9.9 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure
DIASTOLIC BLOOD PRESSURE (MM HG) STANDING
|
18.8 Percentage of participants
|
25.0 Percentage of participants
|
21.4 Percentage of participants
|
20.0 Percentage of participants
|
27.9 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure
DIASTOLIC BLOOD PRESSURE (MM HG) SUPINE
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Day 85 and Day 169Population: All Treated participants
RESPIRATION RATE (RESP) (PER MIN) RESP \> 16 OR RESP CHANGE FROM BASELINE \> 10
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate
|
85.5 Percentage of participants
|
75.0 Percentage of participants
|
70.0 Percentage of participants
|
81.7 Percentage of participants
|
82.4 Percentage of participants
|
SECONDARY outcome
Timeframe: At Day 85 and Day 169Population: All Treated participants
TEMPERATURE (TEMP) (C) TEMP \> 38.3 OR TEMP CHANGE FROM BASELINE \> 1.6
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature
|
0 Percentage of participants
|
1.5 Percentage of participants
|
1.4 Percentage of participants
|
1.4 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of short-term double-blind study medication or up to the day prior to the start of long-term extension period, whichever is earlier.Population: All treated participants
QTc (corrected QT) Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
QRS Interval (msec) <= 120
|
67 Participants
|
66 Participants
|
67 Participants
|
70 Participants
|
68 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
PR Interval (msec) > 200
|
0 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
QRS Interval (msec) > 120
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Change from baseline in QTCF (msec) <= 30
|
59 Participants
|
54 Participants
|
55 Participants
|
62 Participants
|
66 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Change from baseline in QTCF (msec) 30 To <= 60
|
7 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Change from baseline in QTCF (msec) > 60
|
2 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
QTC Fredericia (msec) <= 450
|
58 Participants
|
58 Participants
|
56 Participants
|
65 Participants
|
56 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
QTC Fredericia (msec) 450< To <= 480
|
8 Participants
|
5 Participants
|
11 Participants
|
5 Participants
|
12 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
QTC Fredericia (msec) 480 < to <= 500
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
QTC Fredericia (msec) > 500
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
PR Interval (msec) <= 200
|
68 Participants
|
64 Participants
|
66 Participants
|
68 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: Day 169Population: Pharmacokinetic population
Pharmacokinetics of BMS-931699 derived from serum concentration versus time data; Ctrough = Trough level serum concentration of BMS-931699 at time point specified Pharmacokinetic Population: defined as all subjects who receive any study medication and have any available concentration-time data.
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified
|
640.8 ng/mL
Standard Deviation 436.35
|
207.1 ng/mL
Standard Deviation 149.53
|
62.2 ng/mL
Standard Deviation 56.83
|
0 ng/mL
Standard Deviation 0
|
2040 ng/mL
Standard Deviation 945.57
|
SECONDARY outcome
Timeframe: At Day 85 and Day 169Population: All Treated participants with at Least One Post-Treatment Biomarker Measurement
Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Serum Biomarkers C3, C4
C3, Baseline
|
1.029 g/L
Standard Deviation 0.3265
|
0.990 g/L
Standard Deviation 0.3318
|
1.028 g/L
Standard Deviation 0.3149
|
0.991 g/L
Standard Deviation 0.2641
|
1.068 g/L
Standard Deviation 0.3405
|
|
Serum Biomarkers C3, C4
C3, Day 85
|
1.014 g/L
Standard Deviation 0.3428
|
1.030 g/L
Standard Deviation 0.3225
|
1.083 g/L
Standard Deviation 0.3124
|
0.986 g/L
Standard Deviation 0.3005
|
1.037 g/L
Standard Deviation 0.3024
|
|
Serum Biomarkers C3, C4
C3, Day 169
|
1.010 g/L
Standard Deviation 0.3557
|
1.027 g/L
Standard Deviation 0.3528
|
1.077 g/L
Standard Deviation 0.3256
|
0.992 g/L
Standard Deviation 0.2981
|
1.045 g/L
Standard Deviation 0.3405
|
|
Serum Biomarkers C3, C4
C4, Baseline
|
0.185 g/L
Standard Deviation 0.1088
|
0.177 g/L
Standard Deviation 0.0861
|
0.202 g/L
Standard Deviation 0.0984
|
0.183 g/L
Standard Deviation 0.0824
|
0.201 g/L
Standard Deviation 0.1084
|
|
Serum Biomarkers C3, C4
C4, Day 85
|
0.195 g/L
Standard Deviation 0.1079
|
0.190 g/L
Standard Deviation 0.0875
|
0.215 g/L
Standard Deviation 0.0965
|
0.179 g/L
Standard Deviation 0.0824
|
0.206 g/L
Standard Deviation 0.1037
|
|
Serum Biomarkers C3, C4
C4, Day 169
|
0.185 g/L
Standard Deviation 0.1014
|
0.187 g/L
Standard Deviation 0.0941
|
0.207 g/L
Standard Deviation 0.0927
|
0.184 g/L
Standard Deviation 0.0896
|
0.212 g/L
Standard Deviation 0.1161
|
SECONDARY outcome
Timeframe: At Day 85 and Day 169Population: All Treated participants with at Least One Post-Treatment Biomarker Measurement
Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169. No anti-dsDNA data was available for this report
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=66 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=67 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=70 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
Baseline Positive Day 85 Positive
|
96.6 Percentage
|
98.2 Percentage
|
98.0 Percentage
|
100.0 Percentage
|
88.7 Percentage
|
|
Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
Baseline Negative Day 169 Negative
|
33.3 Percentage
|
100.0 Percentage
|
57.1 Percentage
|
40.0 Percentage
|
71.4 Percentage
|
|
Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
Baseline Negative Day 169 Positive
|
66.7 Percentage
|
0 Percentage
|
42.9 Percentage
|
60.0 Percentage
|
28.6 Percentage
|
|
Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
Baseline Positive Day 169 Negative
|
2.0 Percentage
|
5.8 Percentage
|
4.3 Percentage
|
1.8 Percentage
|
9.3 Percentage
|
|
Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
Baseline Positive Day 169 Positive
|
98.0 Percentage
|
94.2 Percentage
|
95.7 Percentage
|
98.2 Percentage
|
90.7 Percentage
|
|
Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
Baseline Negative Day 85 Negative
|
57.1 Percentage
|
100.0 Percentage
|
50.0 Percentage
|
60.0 Percentage
|
62.5 Percentage
|
|
Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
Baseline Negative Day 85 Positive
|
42.9 Percentage
|
0 Percentage
|
50.0 Percentage
|
40.0 Percentage
|
37.5 Percentage
|
|
Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
Baseline Positive Day 85 Negative
|
3.4 Percentage
|
1.8 Percentage
|
2.0 Percentage
|
0 Percentage
|
11.3 Percentage
|
SECONDARY outcome
Timeframe: At Day 85 and Day 169Population: All Treated participants with at Least One Post-Treatment Biomarker Measurement
Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=66 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=67 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Short Term: Receptor Occupancy Over Time
%CD4+ RO Baseline
|
0 Percentage
Standard Deviation 0
|
0 Percentage
Standard Deviation 0
|
0 Percentage
Standard Deviation 0
|
0 Percentage
Standard Deviation 0
|
0 Percentage
Standard Deviation 0
|
|
Short Term: Receptor Occupancy Over Time
%CD4+ RO Day 85
|
83.244 Percentage
Standard Deviation 28.9616
|
70.520 Percentage
Standard Deviation 32.9107
|
37.155 Percentage
Standard Deviation 31.2927
|
0.350 Percentage
Standard Deviation 0.5997
|
95.722 Percentage
Standard Deviation 12.1298
|
|
Short Term: Receptor Occupancy Over Time
%CD4+ RO Day 169
|
77.210 Percentage
Standard Deviation 29.3976
|
74.286 Percentage
Standard Deviation 28.5105
|
44.115 Percentage
Standard Deviation 34.3707
|
0.334 Percentage
Standard Deviation 0.4460
|
92.390 Percentage
Standard Deviation 22.1377
|
|
Short Term: Receptor Occupancy Over Time
%CD8+ RO Baseline
|
0 Percentage
Standard Deviation 0
|
0 Percentage
Standard Deviation 0
|
0 Percentage
Standard Deviation 0
|
0 Percentage
Standard Deviation 0
|
0 Percentage
Standard Deviation 0
|
|
Short Term: Receptor Occupancy Over Time
%CD8+ RO Day 85
|
81.730 Percentage
Standard Deviation 30.4345
|
68.960 Percentage
Standard Deviation 32.0543
|
32.516 Percentage
Standard Deviation 29.7242
|
0.160 Percentage
Standard Deviation 0.3120
|
95.831 Percentage
Standard Deviation 7.6571
|
|
Short Term: Receptor Occupancy Over Time
%CD8+ RO Day 169
|
74.726 Percentage
Standard Deviation 33.0060
|
69.850 Percentage
Standard Deviation 30.5880
|
40.989 Percentage
Standard Deviation 31.9867
|
0.235 Percentage
Standard Deviation 0.5438
|
92.043 Percentage
Standard Deviation 20.6963
|
SECONDARY outcome
Timeframe: Day 169Population: All Treated participants with at Least One Post-Treatment Immunogenicity Assessment Who Developed Laboratory Reported Positive Antibody Responses to BMS-931699
Immunogenicity defined as positive for anti-drug antibodies post-baseline measurement if baseline missing or negative. If baseline is positive, then immunogenicity is defined as a positive post-baseline measurement with titer value 4 times greater than baseline. (A) all subjects with a laboratory reported positive antibody responses to BMS-931699 during the short-term double-blind treatment period are included. Overall: At least one positive sample relative to baseline during short-term double-blind and follow-up period.
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=34 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=34 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=26 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=41 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified
% with Neutralizing activity
|
41.2 Percentage of participants
|
64.7 Percentage of participants
|
34.1 Percentage of participants
|
—
|
23.1 Percentage of participants
|
|
Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified
% with Neutralizing activity (Baseline)
|
5.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
0 Percentage of participants
|
|
Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified
% with Neutralizing activity (Overall)
|
35.3 Percentage of participants
|
64.7 Percentage of participants
|
34.1 Percentage of participants
|
—
|
23.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
HEMATOLOGY I: ERYTHROCYTE/PLATELET ATTRIBUTES HEMOGLOBIN G/L L \< 0.85×PRE-RX; HEMATOCRIT VOL L \< 0.85×PRE-RX; PLATELET COUNT X10\*9 C/L H \> 1.5×ULN (ULN = Upper Limit of Normal) IF PRE-RX IS MISSING OR \> 1.5×ULN PLATELET COUNT X10\*9 C/L L \< 0.85×LLN (LLN = Lower Limit of Normal) IF PRE-RX IS MISSING OR \< 0.85×LLN IF PRE-RX \>= LLN OR \< 0.85×PRE-RX IF PRE-RX \< LLN; ERYTHROCYTES RBC X10\*12 C/L L \< 0.85×PRE-RX HEMATOLOGY II QUANTITATIVE WBC : LEUKOCYTES X10\*9 C/L H \> 1.2×ULN IF PRE-RX IS MISSING OR \> 1.2×ULN IF LLN \<= PRE-RX \<= ULN OR \> 1.5×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN; LEUKOCYTES WBC X10\*9 C/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF LLN \<= PRE-RX \<= ULN OR \< 0.85×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Erythrocytes Low
|
4 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Erythrocytes High
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Hematocrit Low
|
10 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Hematocrit High
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Hemoglobin Low
|
4 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Hemoglobin High
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Platelet count low
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Platelet count high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Quantitative WBC: Leukocytes low
|
18 Participants
|
12 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Quantitative WBC: Leukocytes high
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
WBC DIFFERENTIAL COUNT: BASOPHILS (ABSOLUTE) X10\*9 C/L H \> 0.4; BLASTS (ABSOLUTE) X10\*9 C/L H \> 0; EOSINOPHILS (ABSOLUTE) EOSA X10\*9 C/L H \> 0.75; LYMPHOCYTES (ABSOLUTE) X10\*9 C/L H \> 7.5; LYMPHOCYTES (ABSOLUTE) X10\*9 C/L L \< 0.75; MONOCYTES (ABSOLUTE) X10\*9 C/L H \> 2; NEUTROPHILS (ABSOLUTE) X10\*9 C/L L \< 1.5 IF PRE-RX IS MISSING OR \< 1.5 IF PRE-RX \>= 1.5 OR \< 0.85×PRE-RX IF PRE-RX \< 1.5; COAGULATION activated Partial thromboplastin time (APTT) SEC H \> 1.5×ULN; INTL NORMALIZED RATIO (INR) INR FRACTION H \> 1.5×ULN PROTHROMBIN TIME (PT) PT SEC H \> 1.5×ULN
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Basophils (Absolute) Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Basophils (Absolute) High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Blasts (Absolute) Low
|
NA Participants
Not evaluated
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Blasts (Absolute) High
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Eosinophils (Absolute) Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Eosinophils (Absolute) High
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Lymphocytes (Absolute) Low
|
29 Participants
|
24 Participants
|
25 Participants
|
25 Participants
|
21 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Lymphocytes (Absolute) High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Monocytes (Absolute) High
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Monocytes (Absolute) Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Neutrophils (Absolute) Low
|
8 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
10 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Neutrophils (Absolute) High
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
LIVER FUNCTION TESTS:ALKALINE PHOSPHATASE (ALP) ALP U/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN; BILIRUBIN, DIRECT UMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN G-GLUTAMYL TRANSFERASE (GGT) GGT U/L H \> 1.15×ULN IF PRE-RX IS MISSING OR \> 1.15×ULN IF PRE-RX \<= ULN OR \> 1.2×PRE-RX IF PRE-RX \> ULN BILIRUBIN, TOTAL UMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Alanine Aminotransferase Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Alanine Aminotransferase High
|
17 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
12 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Alkaline Phosphatase Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Alkaline Phosphatase High
|
3 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Aspartate Aminotransferase Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Aspartate Aminotransferase High
|
13 Participants
|
11 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Bilirubin, Direct Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Bilirubin Direct, High
|
13 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Bilirubin Total, Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Bilirubin Total, High
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
G-Glutamyl Transferase, Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
G-Glutamyl Transferase, High
|
14 Participants
|
16 Participants
|
15 Participants
|
13 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
KIDNEY FUNCTION TESTS:BLOOD UREA NITROGEN MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.2×PRE-RX IF PRE-RX \> ULN CREATININE UMOL/L H \> 1.5×ULN IF PRE-RX IS MISSING OR \> 1.5×ULN IF PRE-RX \<= ULN OR \> 1.33×PRE-RX IF PRE-RX \> ULN GLOMERULAR FILTRATION RATE, CALC. ML/S/M\*2 L \< 0.8×PRE-RX; UREA UREA MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.2×PRE-RX IF PRE-RX \> ULN
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
Blood Urea Nitrogen, Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
Blood Urea Nitrogen, High
|
11 Participants
|
3 Participants
|
14 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
Creatinine, Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
Creatinine, High
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
GLOMERULAR FILTRATION RATE, CALC. Low
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
GLOMERULAR FILTRATION RATE, CALC. High
|
—
|
NA Participants
Not evaluated
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
Urea, Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
—
|
NA Participants
Not evaluated
|
|
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
Urea, High
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
CALCIUM, TOTAL MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.1×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN; CALCIUM, TOTAL MMOL/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN; CHLORIDE, SERUM MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.1×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN; CHLORIDE, SERUM MMOL/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN;
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1
Calcium, Total, Low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1
Calcium, Total, High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1
Chloride, Serum, Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1
Chloride, Serum, High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
BICARBONATE MMOL/L H \> 1.2×ULN IF PRE-RX IS MISSING OR \> 1.2×ULN IF PRE-RX \<= ULN OR \> 1.2×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN; BICARBONATE MMOL/L L \< 0.8×LLN IF PRE-RX IS MISSING OR \< 0.8×LLN IF PRE-RX \>= LLN OR \< 0.8×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN; POTASSIUM, SERUM MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.1×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN; POTASSIUM, SERUM MMOL/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN; MAGNESIUM, SERUM MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.1×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN MAGNESIUM, SERUM MMOL/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2
Bicarbonate, Low
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2
Bicarbonate, High
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2
Magnesium, Serum, Low
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2
Magnesium, Serum, High
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2
Potassium, Serum, Low
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2
Potassium, Serum, High
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
SODIUM, SERUM MMOL/L H \> 1.05×ULN IF PRE-RX IS MISSING OR \> 1.05×ULN IF PRE-RX \<= ULN OR \> 1.05×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN SODIUM, SERUM MMOL/L L \< 0.95×LLN IF PRE-RX IS MISSING OR \< 0.95×LLN IF PRE-RX \>= LLN OR \< 0.95×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN PHOSPHORUS, INORGANIC PHOS MMOL/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN PHOSPHORUS, INORGANIC PHOS MMOL/L L \< 0.85×LLN IF PRE-RX IS MISSING OR \< 0.85×LLN IF PRE-RX \>=LLN OR \< 0.85×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3
Sodium, Serum Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3
Sodium, Serum High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3
Phosphorus, Inorganic, Low
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3
Phosphorus, Inorganic, High
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
GLUCOSE TESTS:GLUCOSE, FASTING SERUM MMOL/L H \> 1.3×ULN IF PRE-RX IS MISSING OR \> 1.3×ULN IF PRE-RX \<= ULN OR \> 2×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN GLUCOSE, FASTING SERUM MMOL/L L \< 0.8×LLN IF PRE-RX IS MISSING OR \< 0.8×LLN IF PRE-RX \>= LLN OR \< 0.8×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN; PROTEIN TESTS:ALBUMIN G/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN PROTEIN, TOTAL G/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.1×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN PROTEIN, TOTAL G/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1
Glucose, Fasting serum, Low
|
3 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1
Glucose, Fasting Serum, High
|
3 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1
Albumin, Low
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1
Albumin, High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1
Protein, Total, Low
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1
Protein, Total, High
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
OTHER CHEMISTRY TESTING LIPID TESTS: CHOLESTEROL, TOTAL (TC) MMOL/L H \> 1.2×ULN IF PRE-RX IS MISSING OR \> 1.2×ULN IF PRE-RX \<= ULN OR \> 1.2×PRE-RX IF PRE-RX \> ULN TRIGLYCERIDES, FASTING MMOL/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.5×PRE-RX IF PRE-RX \> ULN PANCREATIC TESTS: AMYLASE, TOTAL U/L H \> 1.5×ULN; LIPASE, TOTAL (TURBIDIMETRIC ASSAY) U/L H \> 1.5×ULN; LIPASE, TOTAL (COLORIMETRIC ASSAY) U/L H \> 1.5×ULN; ENDOCRINE TESTS:CORTISOL, AM NMOL/L L \< 138 THYROID STIMULATING HORMONE (TSH) TSH MU/L H \> 1.5×ULN IF PRE-RX IS MISSING OR \> 1.5×ULN IF PRE-RX \<= ULN OR \> 2×PRE-RX IF PRE-RX \> ULN
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Cholesterol, Total (TC) Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Cholesterol, Total (TC) High
|
4 Participants
|
12 Participants
|
10 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Triglycerides, Fasting Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Triglycerides, Fasting High
|
13 Participants
|
12 Participants
|
10 Participants
|
8 Participants
|
12 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Amylase, Total Low
|
—
|
NA Participants
Not evaluated
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Amylase, Total High
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Lipase, Total (Colorimetric Assay) Low
|
—
|
NA Participants
Not evaluated
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Lipase, Total (Colorimetric Assay) High
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Lipase, Total (Turbidimetric Assay) Low
|
—
|
NA Participants
Not evaluated
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Lipase, Total (Turbidimetric Assay) High
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Thyroid Stimulating Hormone, Low
|
—
|
NA Participants
Not evaluated
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Thyroid Stimulating Hormone, High
|
—
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
OTHER CHEMISTRY TESTING CARDIAC TESTS: CREATINE KINASE (CK) CK U/L H \> 1.5×ULN IF PRE-RX IS MISSING OR \> 1.5×ULN IF PRE-RX \<= ULN OR \> 1.5×PRE-RX IF PRE-RX \> ULN; TROPONIN-I, CARDIAC SPECIFIC UG/L H \> ULN; METABOLITE TESTS:URIC ACID URIC MMOL/L H \> 1.2×ULN IF PRE-RX IS MISSING OR \> 1.2×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN; CHEM TEST, MULTI INDICATIONS : LACTATE DEHYDROGENASE (LD) LD U/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.5×PRE-RX IF PRE-RX \> ULN
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
Creatine Kinase Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
Creatine Kinase High
|
5 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
TROPONIN-I, CARDIAC SPECIFIC Low
|
—
|
NA Participants
Not evaluated
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
TROPONIN-I, CARDIAC SPECIFIC High
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
Uric Acid, Low
|
—
|
NA Participants
Not evaluated
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
Uric Acid, High
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
Lactate dehydrogenase (LD) low
|
—
|
NA Participants
Not evaluated
|
—
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
Lactate dehydrogenase (LD) high
|
—
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
IMMUNE ACTIVATION MARKERS:C-REACTIVE PROTEIN (CRP) CRP MG/L H \> 1.5×ULN; CRP, HIGH SENSITIVITY MG/L H \> 1.5×ULN;
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY
C-Reactive Protein (CRP) High
|
18 Participants
|
22 Participants
|
18 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY
C-Reactive Protein (CRP) Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY
CRP, High Sensitivity Low
|
—
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
—
|
—
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY
CRP, High Senstivity High
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 42 days post last dose of study medication in short-term or long-term extension periodPopulation: All treated participants
QUALITATIVE URINE CHEMISTRY: BLOOD, URINE N/A H \>= 2 IF PRE-RX IS MISSING OR \>= 2 IF PRE-RX \< 1 OR \>= 2×PRE-RX IF PRE-RX \>= 1 GLUCOSE, URINE N/A H \>= 1 IF PRE-RX IS MISSING OR \>= 1 IF PRE-RX \< 1 OR \>= 2×PRE-RX IF PRE-RX \>= 1 PROTEIN, URINE UNKNOWN H \>= 2 IF PRE-RX IS MISSING OR \>= 2 IF PRE-RX \< 1 OR \>= 2×PRE-RX IF PRE-RX \>= 1 URINALYSIS II URINE WBC + RBC ; RBC, URINE HPF H \>= 2 IF PRE-RX IS MISSING OR \>= 2 IF PRE-RX \< 2 OR \>= 4 IF PRE-RX \>= 2 WBC, URINE HPF H \>= 2 IF PRE-RX IS MISSING OR \>= 2 IF PRE-RX \< 2 OR \>= 4 IF PRE-RX \>= 2
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
Blood, Urine, Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
Blood, Urine, High
|
21 Participants
|
20 Participants
|
21 Participants
|
20 Participants
|
18 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
Glucose, Urine, Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
Glucose, Urine, High
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
Protein, Urine, Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
Protein, Urine, High
|
7 Participants
|
13 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
RBC, Urine, Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
RBC, Urine, High
|
19 Participants
|
13 Participants
|
17 Participants
|
18 Participants
|
18 Participants
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
WBC, Urine, Low
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
NA Participants
Not evaluated
|
|
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
WBC, Urine, High
|
29 Participants
|
31 Participants
|
31 Participants
|
25 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: At baseline, Day 85 and Day 169Population: All randomized and treated participants
Systemic Lupus Erythematosus Disease Activity Index, SLEDAI; Version 2000, also known as SLEDAI-2K. The SLEDAI-2K score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169
SLEDAI-2K Score Day 85
|
-3.24 Score
Standard Deviation 3.320
|
-3.17 Score
Standard Deviation 3.304
|
-4.02 Score
Standard Deviation 3.960
|
-3.29 Score
Standard Deviation 3.953
|
-3.61 Score
Standard Deviation 3.345
|
|
Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169
SLEDAI-2K Score Day 169
|
-4.17 Score
Standard Deviation 4.064
|
-3.98 Score
Standard Deviation 3.478
|
-4.82 Score
Standard Deviation 4.078
|
-4.15 Score
Standard Deviation 3.728
|
-4.88 Score
Standard Deviation 3.370
|
SECONDARY outcome
Timeframe: At baseline, Day 85 and Day 169Population: All randomized and treated participants
Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very good and 100 mm = very bad.
Outcome measures
| Measure |
Experimental: 12.5mg SC BMS-931699 Every Other Week
n=68 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 5mg SC Injection BMS-931699 Every Other Week
n=68 Participants
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Experimental: 1.25mg SCBMS-931699 Every Other Week
n=70 Participants
Subjects received 1.25 mg lulizumab pegol SC injection EOW
|
Placebo Comparator: 0mg SC Weekly BMS-931699
n=71 Participants
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Experimental: 12.5mg SC BMS-931699 Weekly
n=69 Participants
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
|---|---|---|---|---|---|
|
Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169
MDGA score Day 85
|
-23.87 Score
Standard Deviation 20.321
|
-21.00 Score
Standard Deviation 20.596
|
-20.55 Score
Standard Deviation 17.233
|
-23.83 Score
Standard Deviation 20.752
|
-28.77 Score
Standard Deviation 18.193
|
|
Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169
MDGA score Day 169
|
-26.87 Score
Standard Deviation 21.284
|
-28.68 Score
Standard Deviation 19.919
|
-26.71 Score
Standard Deviation 18.182
|
-25.28 Score
Standard Deviation 19.952
|
-29.30 Score
Standard Deviation 17.371
|
Adverse Events
Placebo - Short Term (ST)
Serious events: 6 serious events
Other events: 41 other events
Deaths: 0 deaths
Lulizumab Pegol 12.5 mg Weekly - ST
Serious events: 5 serious events
Other events: 45 other events
Deaths: 2 deaths
Lulizumab Pegol 12.5 mg EOW - ST
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
Lulizumab Pegol 5 mg EOW - ST
Serious events: 9 serious events
Other events: 47 other events
Deaths: 0 deaths
Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST
Serious events: 8 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo - Short Term (ST)
n=71 participants at risk
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Lulizumab Pegol 12.5 mg Weekly - ST
n=69 participants at risk
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
Lulizumab Pegol 12.5 mg EOW - ST
n=68 participants at risk
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Lulizumab Pegol 5 mg EOW - ST
n=68 participants at risk
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST
n=70 participants at risk
Subjects received 1.25 mg lulizumab pegol SC injection EOW.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Gastrointestinal disorders
Lupus enteritis
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
General disorders
Chest pain
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.4%
1/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Immune system disorders
Serum sickness
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Cellulitis
|
4.2%
3/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Infected skin ulcer
|
1.4%
1/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Lung infection
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Zika virus infection
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Nervous system disorders
Putamen haemorrhage
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Pregnancy, puerperium and perinatal conditions
Imminent abortion
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Psychiatric disorders
Depression
|
1.4%
1/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Renal and urinary disorders
Lupus nephritis
|
2.8%
2/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
Other adverse events
| Measure |
Placebo - Short Term (ST)
n=71 participants at risk
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
|
Lulizumab Pegol 12.5 mg Weekly - ST
n=69 participants at risk
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
|
Lulizumab Pegol 12.5 mg EOW - ST
n=68 participants at risk
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
|
Lulizumab Pegol 5 mg EOW - ST
n=68 participants at risk
Subjects received 5 mg SC injection of lulizumab pegol EOW.
|
Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST
n=70 participants at risk
Subjects received 1.25 mg lulizumab pegol SC injection EOW.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.2%
5/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.3%
3/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.8%
4/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.9%
4/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.5%
11/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
10.1%
7/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.4%
5/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.1%
5/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
4/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.2%
5/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.4%
5/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.1%
5/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
General disorders
Chest pain
|
5.6%
4/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
General disorders
Injection site pain
|
5.6%
4/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.9%
4/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
General disorders
Injection site reaction
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.8%
4/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
General disorders
Pyrexia
|
2.8%
2/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.7%
4/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Bronchitis
|
4.2%
3/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.8%
4/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
11.6%
8/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Influenza
|
2.8%
2/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.9%
4/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
5/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
13.0%
9/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.9%
4/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
11.8%
8/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
8.6%
6/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Pharyngitis
|
5.6%
4/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.4%
5/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
10.3%
7/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.3%
3/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
3/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
10.1%
7/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
11.8%
8/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
11.4%
8/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Urinary tract infection
|
4.2%
3/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
8.7%
6/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
16.2%
11/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
13.2%
9/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
15.7%
11/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Infections and infestations
Vaginal infection
|
1.4%
1/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.4%
5/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.4%
1/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.8%
4/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.9%
4/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
4/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
3/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.2%
5/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.9%
4/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.8%
2/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.3%
3/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.7%
4/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.8%
2/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.2%
5/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Nervous system disorders
Dizziness
|
4.2%
3/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.3%
3/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.1%
5/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Nervous system disorders
Headache
|
12.7%
9/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
14.5%
10/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
13.2%
9/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
10.3%
7/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
7.1%
5/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Nervous system disorders
Migraine
|
2.8%
2/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.9%
4/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.4%
1/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
5.9%
4/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
0.00%
0/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
|
Psychiatric disorders
Insomnia
|
5.6%
4/71 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/69 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
4.4%
3/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
1.5%
1/68 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
2.9%
2/70 • All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER