Approval Probability
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Adjusted LOA
ML Risk
BMS-931699 · 1 trial · 1 indication
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...
BMS-931699 is an investigational small molecule being developed for the treatment of lupus. It is in Phase 2 clinical development and has been studied in a completed trial for systemic lupus erythematosus.
BMS-931699 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY.
BMS-931699 is in Phase 2 clinical development. It is an investigational drug and is not approved by the FDA. One Phase 2 trial has been completed.
BMS-931699 has been studied in one completed Phase 2 trial, NCT02265744, which evaluated its safety and efficacy in treating systemic lupus erythematosus. The trial enrolled 730 participants across multiple countries.
BMS-931699 is a small molecule, not a biologic. The completed trial NCT02265744 was titled as a study of a biologic, but the drug itself is classified as a small molecule modality.