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LY3090106- SQ

Phase 1

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

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 used for in rheumatoid arthritis?

LY3090106 SQ is an investigational monoclonal antibody being studied for the treatment of rheumatoid arthritis. It is administered subcutaneously and is currently in Phase 1 clinical development. The drug is being evaluated in patients with rheumatoid arthritis as well as in healthy participants to assess its safety and tolerability.

Who is developing LY3090106 SQ?

LY3090106 SQ is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical research on this investigational monoclonal antibody for the treatment of rheumatoid arthritis.

What phase is LY3090106 SQ in?

LY3090106 SQ is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial has been completed, and the drug remains under investigation for rheumatoid arthritis.

What clinical trials is LY3090106 SQ in?

LY3090106 SQ has been studied in one clinical trial, identified as NCT01925157, titled "A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)." This Phase 1 trial was completed and enrolled 43 participants across Bulgaria, Moldova, Poland, and Romania.

Is LY3090106 SQ the same as LY3090106?

LY3090106 SQ refers to the subcutaneous formulation of the investigational drug LY3090106. The SQ designation indicates the route of administration, which is subcutaneous injection. The drug is being developed by Eli Lilly and Company for the treatment of rheumatoid arthritis.