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SB-681323

Phase 2

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |GSK plc|Last Updated: Jul 31, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment189
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00320450SB-681323 In Subjects With Rheumatoid ArthritisPHASE2 COMPLETED 78 — — Nov 1, 2005Oct 1, 2006Nov 4, 201341 Denmark, Germany +7
NCT00134693A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid ArthritisPHASE2 COMPLETED 77 — — Jun 21, 2005Aug 3, 2006Jul 31, 201728 Australia, France +3
NCT00439881A Study To Look At The Safety Of SB-681323 In Healthy Adult Subjects After Intravenous Administration Of A Single DosePHASE1 COMPLETED 16 — — Oct 1, 2006 -Jun 4, 20121 United Kingdom
NCT00419809SB-681323-Methotrexate Interaction StudyPHASE1 COMPLETED 18 — — May 1, 2005Dec 1, 2005Jun 4, 20122 Australia
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Study Endpoints
Primary Endpoints
Serum levels of CRP at the end of study (after 28 days of treatment) following repeat dosing with SB-681323 (7.5mg/day) compared with placebo.
28 Days
Analysis for C-Reactive protein (CRP) levels 72 hours post-dose following SB-681323
Day 3 (at 72 hour)

CRP levels were compared between SB-681323 and placebo 72 hours post-dose. The ratio of the dose response relationship of placebo and 7.5mg, 15mg and 25mg of SB-681323 has been presented.

Safety of SB-681323 in terms of frequency/ nature of adverse events and changes in ECG patterns, vital signs and clinical laboratory parameters (including liver function tests) seen upto 48h after a single intravenous dose.
The primary outcome measure is the values of liver function tests following dosing with methotrexate alone (Day 1) and methotrexate and SB-681323 or placebo (Day 15).
Secondary Endpoints
Serum levels of CRP at other available timepoints. The following secondary endpoints will be analysed at all available timepoints: Clinical Symptoms, Safety and Biomarkers, Health Outcome.
28 Days
Analysis of CRP levels 24 and 48 hours post-dose following SB-681323
Day 1 (at 24 hour) and Day 2 (at 48 hour)
Analysis of Interleukin (IL)-6 levels up to 72 hours post-dose following SB-681323
Upto Day 3 (at 1, 3, 24 and 72 hour)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SB-681323DRUG -
PrednisoloneDRUG -
SB-681323 oral tabletsDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: * Females cannot be pregnant or lactating. * Must use defined contraceptive methods if of child-bearing potential. * BMI range: 18.5-35.0 kg/m2. * Diagnosis of RA (rheumatoid arthritis) according to revised 1987 American College of Rheumatology (ACR) criteria. * If other RA-medi...

Countries:DenmarkGermanyHong KongItalyNorwayPolandSpainSwedenUnited KingdomAustraliaFranceRussia
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