Phase 2
N=346
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
Lupus
Bottom Line
View on ClinicalTrials.gov: NCT02265744 ↗Enrolled (actual)
346
Serious AEs
9.5%
Results posted
Jan 2019
Primary outcome: Primary: Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 — 59.4; 63.2; 57.4; 58.6 Percentage of participants — p=0.9745
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS-931699 (Drug); Placebo matching BMS-931699 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 |
59.4; 63.2; 57.4; 58.6; 59.2 | 0.9745 |
| SECONDARY Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 |
55.1; 48.5; 39.7; 44.3; 49.3; 37.7 | — |
| SECONDARY Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85 |
49.3; 48.5; 41.2; 47.1; 43.7; 29.0 | — |
| SECONDARY Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85 |
69.6; 64.7; 57.4; 57.1; 54.9 | — |
| SECONDARY Mean Change From Baseline in CLASI Score at Day 85 and Day 169 |
-2.31; -3.20; -1.69; -1.82; -3.11; -3.17 | — |
| 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 |
39.3; 46.9; 34.5; 36.1; 42.4 | — |
| 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 |
-4.63; -4.63; -4.75; -4.42; -3.84 | — |
| SECONDARY Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169 |
-10.31; -8.83; -7.07; -8.66; -7.94; -11.50 | — |
| SECONDARY Cumulative Corticosteroid and Immunosuppressant Use |
89.9; 82.4; 86.8; 84.3; 94.4; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest |
5; 5; 9; 8; 6; 3 | — |
| SECONDARY Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate |
5.9; 2.9; 2.9; 2.9; 5.6; 5.9 | — |
| SECONDARY Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure |
17.6; 11.6; 10.3; 10.0; 15.5; 14.7 | — |
| SECONDARY Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate |
82.4; 85.5; 75.0; 70.0; 81.7 | — |
| SECONDARY Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature |
0; 0; 1.5; 1.4; 1.4 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities |
56; 58; 58; 56; 65; 12 | — |
| SECONDARY Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified |
2040; 640.8; 207.1; 62.2; 0 | — |
| SECONDARY Serum Biomarkers C3, C4 |
1.068; 1.029; 0.990; 1.028; 0.991; 1.037 | — |
| SECONDARY Serum Biomarkers: Anti-Nuclear Antibodies (ANA) |
62.5; 57.1; 100.0; 50.0; 60.0; 37.5 | — |
| SECONDARY Short Term: Receptor Occupancy Over Time |
0; 0; 0; 0; 0; 95.722 | — |
| SECONDARY Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified |
23.1; 41.2; 64.7; 34.1; 0; 5.9 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I |
4; 4; 6; 3; 5; NA | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II |
NA; NA; NA; NA; NA; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS |
NA; NA; NA; NA; NA; 12 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS |
NA; NA; NA; NA; NA; 9 | — |
| SECONDARY Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1 |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2 |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1 |
1; 3; 0; 4; 5; 3 | — |
| SECONDARY Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2 |
NA; NA; NA; NA; NA; 5 | — |
| SECONDARY Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3 |
NA; NA; NA; NA; NA; 5 | — |
| SECONDARY Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY |
NA; NA; NA; NA; NA; 19 | — |
| SECONDARY Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS |
NA; NA; NA; NA; NA; 18 | — |
| SECONDARY Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169 |
-3.61; -3.24; -3.17; -4.02; -3.29; -4.88 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169 |
-28.77; -23.87; -21.00; -20.55; -23.83; -29.30 | — |
Summary
Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Male or female aged between 18 to 70 (included)
- Diagnosed with active systemic lupus erythematosus by a doctor
- Disease must be in patient's joints or on the skin at a minimum
- Taking other medications is allowed but some are excluded
Exclusion Criteria
- Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis
- Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus
Data sourced from ClinicalTrials.gov (NCT02265744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.