Clinical Trials

We are currently enrolling Synergy, a phase 2 study of acazicolcept in patients with Systemic Lupus Erythematosus (NCT04835441). This randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of acazicolcept.

We completed enrollment in a phase 1 study of acazicolcept in healthy volunteers (NCT03748836). This study was designed to evaluate the safety and tolerability of single and multiple ascending intravenous and/or subcutaneous doses of acazicolcept. In addition, pharmacokinetics, pharmacodynamics, and exploratory biomarkers were evaluated to help determine acazicolcept’s potential for the treatment of inflammatory diseases. Results from the single ascending dose, or SAD, portion of the study were discussed at an oral presentation at the 2019 ASH Annual Meeting. Final data were presented at the 2020 EULAR E-Congress.

In October 2022, we voluntarily terminated enrollment in both clinical studies involving davoceticept (ALPN-202) including the NEON-1 (NCT04186637) study of davoceticept as monotherapy and the NEON-2 (NCT04920383) study of davoceticept in combination with pembrolizumab. We are conducting an ongoing, comprehensive assessment of all NEON study participants.

We reported initial data from the ongoing RUBY-1 study, a phase 1 study of povetacicept (ALPN-303) in healthy volunteers (NCT05034484) in September 2022. This study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of povetacicept.