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GSK1550188

Phase 1

Systemic Lupus Erythematosus | Small molecule | Immunology |GSK plc|Last Updated: Jun 12, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

GSK1550188 · 2 trials · 1 indication

Phase 1 2
NCT01516450Japanese phase1 Study of Belimumab (IV vs SC)Systemic Lupus Erythematosus
COMPLETED16 Analytics
NCT01381536Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus
COMPLETED12 Analytics
PHASE1COMPLETED
Japanese phase1 Study of Belimumab (IV vs SC)
Systemic Lupus ErythematosusUnlock trial analytics
PHASE1COMPLETED
Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)
Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline of Vital signs
Day1-Day71

Systolic and diastolic blood pressure, pulse rate, body temperature

Change from baseline of biomarkers
Day-1 - Day71

CD20+, immunoglobulin

Immunogenicity
Day0 - Day71 (if necessary, 6-month)

Presence of anti belimumab antibody

Change from baseline of other safety parameters after single intravenous and subcutaneous administration
Day-1 - Day71

ECGs, clinical laboratory test, local tolerance evaluation (injection site), and adverse events

To evaluate the safety, tolerability
For 84 days

Number of subjects with adverse events (AE) as meaasure of safety and tolerability

Secondary Endpoints

Composite (or profile) of pharmacokinetics after single intravenous administration
Day1-Day71
Composite (or profile) of pharmacokinetics after subcutaneous administration
Day-1 - Day71
To evaluate pharmacokinetics and pharmacodynamics
84days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
GSK1550188 200mg for SCACTIVE_COMPARATORSingle SC dose of belimumab 200mg
GSK1550188 200mg for IVACTIVE_COMPARATORSingle IV dose of belimumab 200 mg
GSK1550188 1mg/kg or 10mg/kgEXPERIMENTALone shot IV

Interventions

NameTypeDescription
GSK1550188 IVDRUGSingle IV dose of belimumab 200 mg
GSK1550188 SCDRUGSingle SC dose of belimumab 200mg
GSK1550188 1mg/kg or 10mg/kgDRUGIV one shot
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Eligibility Criteria

Age Range20 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:Japan
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Frequently asked questions about GSK1550188

What is GSK1550188 used for?

GSK1550188 is an investigational small molecule being developed for systemic lupus erythematosus (SLE). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. Two Phase 1 studies have been completed in Japanese subjects with SLE.

Who makes GSK1550188?

GSK1550188 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in patients with systemic lupus erythematosus.

What phase is GSK1550188 in?

GSK1550188 is in Phase 1 clinical development. Two Phase 1 studies have been completed, both involving Japanese subjects with systemic lupus erythematosus. The drug remains investigational and is not yet approved for any use.

What clinical trials is GSK1550188 in?

GSK1550188 has been studied in two completed Phase 1 trials: NCT01381536, a study in Japanese subjects with systemic lupus erythematosus, and NCT01516450, a Japanese Phase 1 study of belimumab comparing intravenous and subcutaneous administration. Both trials have been completed.

Is GSK1550188 the same as belimumab?

GSK1550188 is a distinct investigational small molecule being developed for systemic lupus erythematosus. One of its completed trials, NCT01516450, is titled as a study of belimumab, suggesting a possible relationship, but the drug is not identified as the same compound in the available data.