Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3462817 · 3 trials · 2 indications
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.
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| LY3462817 300 mg | EXPERIMENTAL | Participants received Intravenous (IV) infusion of 300 mg LY3462817 solution. |
| LY3462817 700 mg | EXPERIMENTAL | Participants received IV infusion of 700 mg LY3462817 solution. |
| Placebo | PLACEBO_COMPARATOR | Participants received IV infusion of 0.9% sodium chloride solution (Placebo). |
| LY3462817 - SC | EXPERIMENTAL | LY3462817 administered subcutaneously (SC) |
| LY3462817 - IV | EXPERIMENTAL | LY3462817 administered intravenously (IV) |
| Placebo - SC | PLACEBO_COMPARATOR | Placebo administered SC |
| Placebo - IV | PLACEBO_COMPARATOR | Placebo administered IV |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Given IV |
| LY3462817 | DRUG | Given IV |
| LY3462817 (SC) | DRUG | Administered SC. |
| Placebo (SC) | DRUG | Administered SC. |
| LY3462817 (IV) | DRUG | Administered IV. |
| Placebo (IV) | DRUG | Administered IV. |
| LY3462817 IV | BIOLOGICAL | Administered IV |
| LY3462817 SC | BIOLOGICAL | Administered SC |
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...
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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.
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.
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.
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.
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.