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LY3090106 - SQ

Phase 1

Rheumatoid Arthritis | Monoclonal antibody | Immunology |Eli Lilly and Company|Last Updated: Oct 1, 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 Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01925157A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)PHASE1 COMPLETED 43Aug 1, 2013Sep 1, 2015Oct 1, 20154 Bulgaria, Moldova +2
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Adverse Event(s) Considered by the Investigator to be Related to Study Drug Administration
Baseline through 12 weeks
Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3090106
Predose through 12 Weeks
Number of Participants with Anti-LY3090106 Antibodies
Baseline through 12 Weeks
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3090106
Predose through 12 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3090106 (Healthy)EXPERIMENTALHealthy participants will receive a single dose of LY3090106 in dose escalation cohorts subcutaneously (SQ).
Placebo (Healthy)PLACEBO_COMPARATORHealthy participants will receive a single dose of placebo matching LY3090106 SQ.
LY3090106 (RA)EXPERIMENTALParticipants with RA will receive a single dose of LY3090106 in dose escalation cohorts SQ or intravenously (IV).
Placebo (RA)PLACEBO_COMPARATORParticipants with RA will receive a single dose of placebo matching LY3090106 SQ.
Interventions
NameTypeDescription
LY3090106 - SQBIOLOGICALAdministered SQ.
LY3090106 - IVBIOLOGICALAdministered IV.
Placebo - SQBIOLOGICALAdministered SQ.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria for Healthy Participants: * Males or non-pregnant females age 18 to 65 years * Body Mass Index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m\^2) Inclusion Criteria for Participants for RA: * Diagnosis of at least mildly active adult-onset RA * Positive anti-citrullina...

Countries:BulgariaMoldovaPolandRomania
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