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SB-659032

Phase 2

Atherosclerosis | Small molecule | Cardiovascular |GSK plc|Trials Updated: Sep 24, 2018

SB-659032 development status

Highest phase Phase 2 (NCT00695305)
Phase scored for GSKPhase 1
Registered trials 2 across 1 sponsor since Jun 2008

SB-659032 target and mechanism

ModalitySmall molecule

Also known as rilapladib

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials5
Total Enrollment305

FDA Designations

No designations recorded

SB-659032 clinical trials

SB-659032 · 5 trials · 3 indications

Phase 2 2Phase 1 3
NCT01428453A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) in Alzheimer's DiseaseAlzheimer's Disease
COMPLETED124 Analytics
NCT00695305An Imaging Study in Patients With Atherosclerosis Taking Rilapladib or Placebo for 12 WeeksAtherosclerosis
COMPLETED83 Analytics
PHASE2COMPLETED
A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) in Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics
PHASE2COMPLETED
An Imaging Study in Patients With Atherosclerosis Taking Rilapladib or Placebo for 12 Weeks
AtherosclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline (Day 0) in Cerebral Spinal Fluid (CSF) Amyloid Beta Peptide (Abeta) 42 and Abeta40 at Week 24
Baseline (Day 0) and Week 24

CSF Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF Abeta42 and Abeta40 are summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.

Change From Baseline (Day 0) in CSF Abeta42/ Abeta40 Ratio at Week 24
Baseline (Day 0) and Week 24

CSF Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF Abeta42/Abeta40 ratio is summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.

Change From Baseline (Day 0) in CSF Tau and Phosphorylated Tau (P-tau) Measures at Week 24
Baseline (Day 0) and Week 24

CSF tau and P-tau were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF tau and P-tau was summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.

Change From Baseline (Day 0) in the Computerized Test Battery for Cognition (CogState) Battery Working Memory/Executive Function (WM/EF) Composite Score at Week 24
Baseline (Day 0) and Week 24

The WM/EF composite score was comprised of 5 functional tests including 1) Controlled oral word association which measured language fluency, planning and working memory, 2) Category naming: It measures semantic fluency, planning and working memory, 3) One-back: This is a measure of working memory. 4) Trail B: This is a measure of motor speed, visual scanning, and visual-motor integration. This test required attention and cognitive flexibility. 5) Go No-Go task: This test evaluate accuracy and reaction time for each response. The composite score calculated by standardizing the total score: sum of all responses obtained from these 5 functional test by using the formula (Total score of ITT population at baseline - Total score at Week 24) /standard deviation of mean total mean score at baseline. The observed composite score ranged from minimum -1.474 and maximum 1.596. Lower score means better cognitive status. Change from Baseline was calculated as post-dose visit minus Baseline value.

Safety from AE reporting, vital signs, clinical labs, ECGs, slit lamp eye exams and electron microscopy of peripheral blood lymphocytes.
12 weeks
LP-PLA2 activity;
12 weeks
changes in mean standard values of 18 FDG uptake as assessed by PET and MRI imaging
12 weeks
Collagen EC50 values on Day 35 (or 21 days post last dose) as determine by optical aggregometry.
on Day 35 (or 21 days post last dose) as determine by optical aggregometry
Platelet aggregation
14 days

Percent maximum platelet aggregation following ADP- and collagen-induced aggregation

Biomarkers of platelet aggregation
14 days

Urinary 11-dehydrothromboxane B2 and blood CD62 concentrations

Secondary Endpoints

Change From Baseline (Day 0) in CSF Albumin Quotients at Week 24
Baseline (Day 0) and Week 24
Change From Baseline (Day 0) in Plasma Levels of Abeta42 and Abeta40 at Week 24
Baseline (Day 0) and Week 24
Change From Baseline (Day 0) in Plasma Levels of Abeta42/Abeta40 Ratio at Week 24
Baseline (Day 0) and Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
250mg rilapladibEXPERIMENTALExperimental drug
placeboPLACEBO_COMPARATORPlacebo comparator
rilapladibACTIVE_COMPARATOR250 mg/day
SB-659032EXPERIMENTAL250 mg non-enteric coated SB-659032

Interventions

NameTypeDescription
250mg rilapladibDRUGExperimental Drug
placeboDRUGPlacebo comparator
rilapladibDRUG250 mg oral dose once daily
18F Fluorodeoxylucose (FDG)-PETOTHERFDG-PET
Rilapladib (SB-659032)DRUG -
SB-659032DRUG -
SB659032DRUGsingle dose
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Eligibility Criteria

Age Range50 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: 1. A clinical diagnosis of possible Alzheimer's disease in accordance with the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with radiological (Magnetic Resonance Imaging \[...

Countries:BulgariaCanadaGermanyItalyNorwaySpainSwedenUnited StatesAustralia
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Frequently asked questions about SB-659032

What is SB-659032?

SB-659032 is an investigational small molecule developed by GSK plc for atherosclerosis, a cardiovascular condition. It has been studied in Phase 1 clinical trials assessing its effects on platelet function and platelet aggregation. It is not an approved therapy and remains in early clinical development.

What is SB-659032 used for in atherosclerosis?

SB-659032 was studied in atherosclerosis research, specifically to assess its effect on platelet function and platelet aggregation in healthy volunteers. Both Phase 1 trials enrolled participants with atherosclerosis listed as the condition. It is investigational and has not been approved for any use.

Who makes SB-659032?

SB-659032 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 1 clinical program evaluating the compound in platelet function and platelet aggregation studies. No other developer or partnership is associated with the asset.

What phase is SB-659032 in?

SB-659032 is in Phase 1. Two Phase 1 trials have been completed, with no active trials ongoing. The program enrolled 40 participants total across both studies. SB-659032 is investigational and has not received FDA approval.

What clinical trials is SB-659032 in?

SB-659032 has been evaluated in two completed Phase 1 trials: NCT01750827, a study assessing the effect of SB 659032 on platelet function in the United States with 14 participants, and NCT01745458, the SB-659032 Platelet Aggregation Study in Australia with 26 participants. Both were randomized, double-blind, and placebo-controlled.

Is SB-659032 the same as SB659032?

Yes, SB659032 is an alternative spelling of SB-659032, referring to the same investigational compound. The hyphenated form SB-659032 appears in trial records, while SB659032 is used without the hyphen. Both names identify the same GSK small molecule studied in Phase 1 for atherosclerosis.