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LY3114062

Phase 1

Inflammatory Arthritis | Small molecule | Other |Eli Lilly and Company|Last Updated: Jul 17, 2015

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02144272Safety Study to Evaluate LY3114062 in Participants With Inflammatory ArthritisPHASE1 COMPLETED 41Jun 1, 2014Jun 1, 2015Jul 17, 20154 Bulgaria, Georgia +2
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Study Endpoints
Primary Endpoints
The Number of Participants with One or More Drug-Related Adverse Events
Baseline to study completion (3 months)
Secondary Endpoints
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062
Predose through Day 85, at specified timepoints
Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062
Predose through Day 85, at specified timepoints
Antibody Production Against LY3114062
Day 1, 8, 15, 29, 85 and early discontinuation
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3114062 (SC)EXPERIMENTALLY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg.
LY3114062 (IV)EXPERIMENTALLY3114062 given once intravenous (IV).
PlaceboPLACEBO_COMPARATORPlacebo (sodium chloride injection) given as a single SC dose.
Interventions
NameTypeDescription
LY3114062 SCDRUGLY3114062 administered SC.
PlaceboDRUGPlacebo administered SC.
LY3114062 IVDRUGLY3114062 administered IV.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Signs or symptoms of an inflammatory arthritis for a duration of at least 8 weeks at screening. * Presence of at least 3 out of 66 swollen joints at screening and baseline, as determined by the swollen joint count assessment forms. Exclusion Criteria: * Synthetic disease-mod...

Countries:BulgariaGeorgiaMoldovaRomania
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