drugset / Trial / NCT04433585

A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)

NCT04433585 ↗

Phase 2 Completed 291 enrolled Nektar Therapeutics Eli Lilly and Company · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and effective in adults with systemic lupus erythematosus (SLE).

Timeline

Start
2020-08-19
Primary completion
2023-01-10
Completion
2023-02-16

Outcome

Missed primary endpoint

registry analysis (superiority test); LY3471851 Mid Dose vs Placebo; p = 0.309; Odds Ratio (OR) 1.46 (95% CI 0.70 to 3.04); Regression, Logistic NCT04433585 ↗

registry analysis (superiority test); LY3471851 Low Dose vs Placebo; p = 0.944; Odds Ratio (OR) 0.97 (95% CI 0.47 to 2.03); Regression, Logistic NCT04433585 ↗

registry analysis (superiority test); LY3471851 High Dose vs Placebo; p = 0.649; Odds Ratio (OR) 0.84 (95% CI 0.40 to 1.78); Regression, Logistic NCT04433585 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rezpegaldesleukin Protein / enzyme biologic — Subcutaneous