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LY3090106- SQ

Phase 1

Rheumatoid Arthritis | Monoclonal antibody | Immunology |Eli Lilly and Company|Trials Updated: Oct 1, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

LY3090106- SQ clinical trials

LY3090106- SQ · 1 trial · 1 indication

Phase 1 1
NCT01925157A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)Rheumatoid Arthritis
COMPLETED43 Analytics
PHASE1COMPLETED
A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)
Rheumatoid ArthritisUnlock trial analytics

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 to 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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Frequently asked questions about LY3090106- SQ

What is LY3090106- SQ?

LY3090106- SQ is an investigational monoclonal antibody developed by Eli Lilly and Company for rheumatoid arthritis. It has been studied in a Phase 1 clinical trial that enrolled 43 participants, including healthy volunteers and people with rheumatoid arthritis. The drug is not approved and remains in clinical development.

What is LY3090106- SQ used for in rheumatoid arthritis?

LY3090106- SQ is being evaluated as a treatment for rheumatoid arthritis, an autoimmune condition. It was tested in a Phase 1 trial that included participants with rheumatoid arthritis alongside healthy volunteers. The study is complete, but the drug has not been approved for any use.

Who makes LY3090106- SQ?

LY3090106- SQ is made by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the developer responsible for the clinical program studying this monoclonal antibody in rheumatoid arthritis.

What phase is LY3090106- SQ in?

LY3090106- SQ is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not received FDA approval for rheumatoid arthritis or any other indication.

What clinical trials is LY3090106- SQ in?

LY3090106- SQ has been studied in one completed Phase 1 trial, NCT01925157, titled A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA). The trial enrolled 43 participants across Bulgaria, Moldova, Poland, and Romania and was randomized, double-blind, and placebo-controlled.

Is LY3090106- SQ the same as LY3090106 - SQ?

Yes, LY3090106- SQ and LY3090106 - SQ refer to the same investigational monoclonal antibody developed by Eli Lilly and Company for rheumatoid arthritis. The only difference is spacing in the name, and both point to the same Phase 1 clinical program.