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LY3090106

Phase 1

Sjögren's Syndrome | Small molecule | Immunology |Eli Lilly and Company|Trials Updated: Dec 11, 2018

LY3090106 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Nov 2015

LY3090106 target and mechanism

ModalitySmall molecule

Also known as LY3090106 - IV

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

LY3090106 clinical trials

LY3090106 · 1 trial · 1 indication

Phase 1 1
NCT02614716A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)Sjögren's Syndrome
COMPLETED32 Analytics
PHASE1COMPLETED
A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)
Sjögren's SyndromeUnlock 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 Study Completion (Day 197)

Secondary Endpoints

Pharmacokinetics: Maximum Concentration (Cmax) of LY3090106
Baseline through Day 197
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3090106
Baseline through Day 197
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3090106EXPERIMENTALLY3090106 given subcutaneously (SC) in escalating dose cohorts once every 2 or 4 weeks for 16 weeks.
PlaceboPLACEBO_COMPARATORPlacebo given subcutaneously (SC) once every 2 or 4 weeks for 16 weeks.

Interventions

NameTypeDescription
LY3090106DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Have a confirmed diagnosis of SS by the American-European Consensus Group criteria with active disease (at any level), as per judgment of the investigator (participants with another concurrent, stable connective tissue disease may be eligible for inclusion, with written approv...

Countries:United StatesBulgariaGeorgiaRomania
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Competitive Landscape -Acute Respiratory Distress Syndrome 27 trials (matched to "Sjögren's Syndrome")

Top 2 of 7 competitors

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Frequently asked questions about LY3090106

What is LY3090106 used for?

LY3090106 is an investigational small molecule being studied for the treatment of Sjögren's Syndrome, an autoimmune condition. It has been evaluated in a Phase 1 clinical trial in adults with the disease. It is not approved for any indication and remains in clinical development.

Who is developing LY3090106?

LY3090106 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 study of the compound in participants with Sjögren's Syndrome.

What phase is LY3090106 in?

LY3090106 is in Phase 1 clinical development. The single reported trial, NCT02614716, was a Phase 1 study in participants with Sjögren's Syndrome and is now completed. The drug is investigational and has not been approved by the FDA.

What clinical trials is LY3090106 in?

LY3090106 has been studied in one clinical trial, NCT02614716, titled A Study of LY3090106 in Participants With Sjögren's Syndrome. The Phase 1 trial enrolled 32 participants across the United States, Bulgaria, Georgia, and Romania and is completed.

Is LY3090106 the same as LY3090106 - IV?

Yes, LY3090106 - IV is an alternative name for LY3090106. Both refer to the same investigational small molecule developed by Eli Lilly and Company for Sjögren's Syndrome.

How was the LY3090106 Sjögren's Syndrome trial designed?

The Phase 1 trial NCT02614716 was a randomized, double-blind, placebo-controlled study of LY3090106 in 32 adults with Sjögren's Syndrome. Participants were 18 years or older, and the study enrolled across the United States, Bulgaria, Georgia, and Romania.