Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK1550188 IV
GSK1550188 · 2 trials · 1 indication
Systolic and diastolic blood pressure, pulse rate, body temperature
CD20+, immunoglobulin
Presence of anti belimumab antibody
ECGs, clinical laboratory test, local tolerance evaluation (injection site), and adverse events
Number of subjects with adverse events (AE) as meaasure of safety and tolerability
| Arm | Type | Description |
|---|---|---|
| GSK1550188 200mg for SC | ACTIVE_COMPARATOR | Single SC dose of belimumab 200mg |
| GSK1550188 200mg for IV | ACTIVE_COMPARATOR | Single IV dose of belimumab 200 mg |
| GSK1550188 1mg/kg or 10mg/kg | EXPERIMENTAL | one shot IV |
| Name | Type | Description |
|---|---|---|
| GSK1550188 IV | DRUG | Single IV dose of belimumab 200 mg |
| GSK1550188 SC | DRUG | Single SC dose of belimumab 200mg |
| GSK1550188 1mg/kg or 10mg/kg | DRUG | IV one shot |
Inclusion Criteria: * Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG. Rationale: Set for the...
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GSK1550188 is an investigational small molecule developed by GSK plc for systemic lupus erythematosus (SLE), an autoimmune disease. It has been studied in Phase 1 clinical trials conducted in Japan. GSK1550188 is not an approved therapy and remains in clinical development.
GSK1550188 has been studied as a treatment for systemic lupus erythematosus (SLE), the autoimmune condition it targets in its clinical program. Both of its Phase 1 trials enrolled subjects with SLE or healthy volunteers in Japan. It is investigational and has not been approved for any use.
GSK1550188 is developed by GSK plc, the British pharmaceutical company that trades under the ticker GSK. GSK sponsored both Phase 1 trials of the compound in Japan, one in healthy volunteers and one in subjects with systemic lupus erythematosus.
GSK1550188 is in Phase 1 development. Both of its clinical trials were Phase 1 studies, and both are now completed. The compound is investigational and has not been approved by the FDA or any other regulatory authority for systemic lupus erythematosus or any other indication.
GSK1550188 has been evaluated in two completed Phase 1 trials: NCT01381536, a Phase 1 study in Japanese subjects with systemic lupus erythematosus that enrolled 12 participants, and NCT01516450, a Japanese Phase 1 study comparing intravenous and subcutaneous administration that enrolled 16 healthy volunteers.