Trial · NCT02265744
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
NCT02265744, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2019-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus. Trials, record NCT02265744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02265744
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
- NCT number
- NCT02265744
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 730 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Lupus
- Interventions
- BMS-931699, Placebo matching BMS-931699
- First posted
- 2014-10-16
- Last updated
- 2019-10-07
- Other registries' IDs
- eudract:2014-002184-14
- Results first posted
- 2019-01-04
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 | At Day 169 | 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. |
| Secondary | Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 | At Day 169 | 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) |
| Secondary | Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85 | At Day 85 | 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) |
| Secondary | Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85 | At Day 85 | 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. |
| Secondary | Mean Change From Baseline in CLASI Score at Day 85 and Day 169 | At Day 85 and Day 169 | 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. |
| Secondary | 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 | At Day 85 and Day 169 | 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. |
| Secondary | 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 | At baseline, Day 85 and Day 169 | 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) |
| Secondary | Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169 | At baseline, Day 85 and Day 169 | 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. |
| Secondary | Cumulative Corticosteroid and Immunosuppressant Use | 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 earlier | Percent of participants requiring use of corticosteroids and mmunosuppressants use over time |
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest | 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 earlier | 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 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 | At Day 169 | All Randomized and Treated participants | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 | At Day 169 | All randomized and treated participants | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85 | At Day 85 | All Randomized and Treated participants | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85 | At Day 85 | All Randomized and Treated Participants | Percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in CLASI Score at Day 85 and Day 169 | At Day 85 and Day 169 | All Randomized and Treated Subjects | Scores on a scale | MEAN |
| SECONDARY | 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 | At Day 85 and Day 169 | All randomized and treated participants | Percentage of participants | NUMBER |
| SECONDARY | 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 | At baseline, Day 85 and Day 169 | All Randomized and Treated Participants | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169 | At baseline, Day 85 and Day 169 | All randomized and treated participants | Score | MEAN |
| SECONDARY | Cumulative Corticosteroid and Immunosuppressant Use | 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 earlier | All randomized and treated participants | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest | 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 earlier | All treated subjects | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group771
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 | Experimental: 12.5mg SC BMS-931699 Weekly | 59.4 | 90% Confidence Interval 49.7 to 69.1 | Percentage of participants | |
| Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 | Experimental: 12.5mg SC BMS-931699 Every Other Week | 63.2 | 90% Confidence Interval 53.6 to 72.9 | Percentage of participants | |
| Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | 57.4 | 90% Confidence Interval 47.5 to 67.2 | Percentage of participants | |
| Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 | Experimental: 1.25mg SCBMS-931699 Every Other Week | 58.6 | 90% Confidence Interval 48.9 to 68.3 | Percentage of participants | |
| Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 | Placebo Comparator: 0mg SC Weekly BMS-931699 | 59.2 | 90% Confidence Interval 49.6 to 68.8 | Percentage of participants | |
| Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 | Experimental: 12.5mg SC BMS-931699 Weekly | SRI (4) | 55.1 | 90% Confidence Interval 45.2 to 64.9 | Percentage of participants |
| Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 | Experimental: 12.5mg SC BMS-931699 Every Other Week | SRI (4) | 48.5 | 90% Confidence Interval 38.6 to 58.5 | Percentage of participants |
| Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | SRI (4) | 39.7 | 90% Confidence Interval 29.9 to 49.5 | Percentage of participants |
| Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 | Experimental: 1.25mg SCBMS-931699 Every Other Week | SRI (4) | 44.3 | 90% Confidence Interval 34.5 to 54.1 | Percentage of participants |
| Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 | Placebo Comparator: 0mg SC Weekly BMS-931699 | SRI (4) | 49.3 | 90% Confidence Interval 39.5 to 59.1 | Percentage of participants |
1 to 10 of 771Source ClinicalTrials.gov
See all 771 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental: 12.5mg SC BMS-931699 Weekly | 69 | |
| Overall Study | STARTED | Experimental: 12.5mg SC BMS-931699 Every Other Week | 68 | |
| Overall Study | STARTED | Experimental: 5mg SC Injection BMS-931699 Every Other Week | 68 | |
| Overall Study | STARTED | Experimental: 1.25mg SCBMS-931699 Every Other Week | 70 | |
| Overall Study | STARTED | Placebo Comparator: 0mg SC Weekly BMS-931699 | 71 | |
| Overall Study | COMPLETED | Experimental: 12.5mg SC BMS-931699 Weekly | 49 | |
| Overall Study | COMPLETED | Experimental: 12.5mg SC BMS-931699 Every Other Week | 53 | |
| Overall Study | COMPLETED | Experimental: 5mg SC Injection BMS-931699 Every Other Week | 51 | |
| Overall Study | COMPLETED | Experimental: 1.25mg SCBMS-931699 Every Other Week | 47 | |
| Overall Study | COMPLETED | Placebo Comparator: 0mg SC Weekly BMS-931699 | 58 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events285
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | Placebo - Short Term (ST) | 0 | 71 | |
| other | Leukopenia | Blood and lymphatic system disorders | Lulizumab Pegol 12.5 mg Weekly - ST | 5 | 69 | |
| other | Leukopenia | Blood and lymphatic system disorders | Lulizumab Pegol 12.5 mg EOW - ST | 3 | 68 | |
| other | Leukopenia | Blood and lymphatic system disorders | Lulizumab Pegol 5 mg EOW - ST | 3 | 68 | |
| other | Leukopenia | Blood and lymphatic system disorders | Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST | 3 | 70 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo - Short Term (ST) | 0 | 71 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Lulizumab Pegol 12.5 mg Weekly - ST | 4 | 69 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Lulizumab Pegol 12.5 mg EOW - ST | 4 | 68 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Lulizumab Pegol 5 mg EOW - ST | 3 | 68 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST | 2 | 70 |
1 to 10 of 285Source ClinicalTrials.gov
See all 285 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - Short Term (ST) | 0 | 71 |
| Total, all-cause mortality | Lulizumab Pegol 12.5 mg Weekly - ST | 2 | 69 |
| Total, all-cause mortality | Lulizumab Pegol 12.5 mg EOW - ST | 0 | 68 |
| Total, all-cause mortality | Lulizumab Pegol 5 mg EOW - ST | 0 | 68 |
| Total, all-cause mortality | Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST | 0 | 70 |
| Total, other adverse events | Placebo - Short Term (ST) | 41 | 71 |
| Total, other adverse events | Lulizumab Pegol 12.5 mg Weekly - ST | 45 | 69 |
| Total, other adverse events | Lulizumab Pegol 12.5 mg EOW - ST | 43 | 68 |
| Total, other adverse events | Lulizumab Pegol 5 mg EOW - ST | 47 | 68 |
| Total, other adverse events | Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST | 39 | 70 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33687069 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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