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Also known as LY3462817 IV, LY3462817 (SC), Peresolimab
LY3462817 · 2 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.
PK: Cmax of Peresolimab
PK: AUC\[0-tlast\] of Peresolimab
PK: AUC(0-∞) of Peresolimab
| 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). |
| Peresolimab (Test 1) | EXPERIMENTAL | Peresolimab administered subcutaneously (SC). |
| Peresolimab (Test 2) | EXPERIMENTAL | Peresolimab administered SC. |
| Peresolimab (Test 3) | EXPERIMENTAL | Peresolimab administered SC. |
| Peresolimab (Reference) | EXPERIMENTAL | Peresolimab administered SC. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Given IV |
| LY3462817 | DRUG | Given IV |
| Peresolimab | DRUG | 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 developed by Eli Lilly and Company for the treatment of rheumatoid arthritis. It is a Phase 2 clinical candidate in the immunology therapeutic area and has been studied in a single completed clinical trial. It is not yet approved for any indication.
LY3462817 is being developed for the treatment of rheumatoid arthritis, an inflammatory joint disease. Its clinical evaluation has been limited to a Phase 2 study in adults with rheumatoid arthritis. The drug remains investigational and is not approved for use in rheumatoid arthritis or any other condition.
LY3462817 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating the monoclonal antibody in rheumatoid arthritis.
LY3462817 is in Phase 2 development. The program has completed one Phase 2 clinical trial in rheumatoid arthritis, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
LY3462817 has been evaluated in one clinical trial, NCT04634253, titled A Study of LY3462817 in Participants With Rheumatoid Arthritis. That Phase 2 trial was completed, enrolled 98 participants, was randomized, double-blind, and placebo-controlled, and included sites in the United States, Czechia, Hungary, Mexico, Poland, Puerto Rico, and the United Kingdom.
Yes. LY3462817 IV and LY3462817 (SC) are alternative designations for the same monoclonal antibody, LY3462817, developed by Eli Lilly and Company. The suffixes refer to intravenous and subcutaneous formulations of the investigational rheumatoid arthritis treatment.