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Also known as LY3462817
Peresolimab · 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...
Peresolimab is an investigational monoclonal antibody developed by Eli Lilly and Company under the code LY3462817. It has been studied in a Phase 1 clinical trial in healthy adult participants. It is not an approved medicine and remains in clinical development.
Peresolimab is made by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the developer of the asset, which is also identified by the internal code LY3462817.
Peresolimab is in Phase 1 development. The only recorded trial is a completed Phase 1 relative bioavailability study in healthy participants. No later-stage trials are listed, so the program remains at an early clinical stage.
Peresolimab has been evaluated in one clinical trial, NCT05959109, titled A Relative Bioavailability Study of Peresolimab (LY3462817) Formulations in Healthy Participants. That Phase 1 study is completed, enrolled 57 participants, and was conducted in the United States.
Yes. Peresolimab is the same asset as LY3462817, which is Eli Lilly and Company's internal code for the monoclonal antibody. The two names refer to the same investigational drug and appear together in the trial title for NCT05959109.
NCT05959109 was a Phase 1 relative bioavailability study of peresolimab (LY3462817) formulations in healthy participants. It enrolled 57 adults aged 18 years and older of any sex, used a controlled design, and was completed in the United States.