Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02265744 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus | PHASE2 | COMPLETED | 730 | — | — | Nov 13, 2014 | Nov 30, 2017 | Oct 7, 2019 | 121 | United States, Argentina +21 |
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.
| Arm | Type | Description |
|---|---|---|
| Experimental:Arm A: BMS-931699 | EXPERIMENTAL | 12.5mg subcutaneous (SC) injection Weekly dosing |
| Experimental:Arm B: BMS-931699 | EXPERIMENTAL | 12.5mg SC injection Every other Week dosing |
| Experimental:Arm C: BMS-931699 | EXPERIMENTAL | 5mg SC injection Every other Week dosing |
| Experimental:Arm D: BMS-931699 | EXPERIMENTAL | 1.25mg SC injection Every other Week dosing |
| Placebo Comparator: Arm E: Placebo matching BMS-931699 | PLACEBO_COMPARATOR | 0mg SC injection Weekly dosing |
| Name | Type | Description |
|---|---|---|
| BMS-931699 | DRUG | - |
| Placebo matching BMS-931699 | DRUG | - |
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 min...