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LY3462817

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Jul 12, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment98

FDA Designations

No designations recorded

Clinical trial landscape

LY3462817 · 3 trials · 2 indications

Phase 2 1Phase 1 2
NCT04634253A Study of LY3462817 in Participants With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED98 Analytics
PHASE2COMPLETED
A Study of LY3462817 in Participants With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP)
Baseline, Week 12

Disease Activity Score (DAS) based on a 28 joint count hsCRP consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56\*square root (sqrt) (TJC28) plus (+) 0.28\*sqrt (SJC28)+ 0.014\* participant's global assessment of disease activity + 0.36\*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. Least Square Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) with treatment, strata (previous RA therapy population), baseline value, visit, treatment-by-visit interaction as fixed factors.

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through Week 12

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Baseline through to final follow-up at approximately Week 12

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints

Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)
Week 12
Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70)
Week 12
Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50)
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY3462817 300 mgEXPERIMENTALParticipants received Intravenous (IV) infusion of 300 mg LY3462817 solution.
LY3462817 700 mgEXPERIMENTALParticipants received IV infusion of 700 mg LY3462817 solution.
PlaceboPLACEBO_COMPARATORParticipants received IV infusion of 0.9% sodium chloride solution (Placebo).
LY3462817 - SCEXPERIMENTALLY3462817 administered subcutaneously (SC)
LY3462817 - IVEXPERIMENTALLY3462817 administered intravenously (IV)
Placebo - SCPLACEBO_COMPARATORPlacebo administered SC
Placebo - IVPLACEBO_COMPARATORPlacebo administered IV

Interventions

NameTypeDescription
PlaceboDRUGGiven IV
LY3462817DRUGGiven IV
LY3462817 (SC)DRUGAdministered SC.
Placebo (SC)DRUGAdministered SC.
LY3462817 (IV)DRUGAdministered IV.
Placebo (IV)DRUGAdministered IV.
LY3462817 IVBIOLOGICALAdministered IV
LY3462817 SCBIOLOGICALAdministered SC
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Have a diagnosis of adult onset RA as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 3 months prior to screening * Have moderately to severely active RA defined by the presence of ≥6 sw...

Countries:United StatesCzechiaHungaryMexicoPolandPuerto RicoUnited KingdomSingapore
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Frequently asked questions about LY3462817

What is LY3462817 used for?

LY3462817 is an investigational monoclonal antibody being studied for use in healthy participants and in participants with rheumatoid arthritis. It is being developed by Eli Lilly and Company and has completed clinical trials in both healthy volunteers and patients with rheumatoid arthritis.

Who makes LY3462817?

LY3462817 is being developed by Eli Lilly and Company, which trades under the ticker symbol LLY. The company has sponsored clinical trials of LY3462817 in healthy participants and in participants with rheumatoid arthritis.

What phase is LY3462817 in?

LY3462817 has completed Phase 1 trials in healthy participants and a Phase 2 trial in participants with rheumatoid arthritis. It is an investigational drug and is not approved by the FDA. All completed trials have finished, and no active trials are currently listed.

What clinical trials is LY3462817 in?

LY3462817 has completed three clinical trials: NCT03715192, a Phase 1 safety study in healthy participants in Singapore; NCT04634253, a Phase 2 study in participants with rheumatoid arthritis across multiple countries; and NCT05440136, a Phase 1 safety study in healthy Japanese and non-Japanese participants in the United States.

Is LY3462817 the same as any other drug?

LY3462817 is the primary name used in clinical trial records for this investigational monoclonal antibody. No alternative names have been reported in the available trial information, so it is not known to be the same as any other drug under a different name.