Alpine's Pipeline

RUBY-2 study, a placebo-controlled, dose-ranging, randomized phase 2 study in systemic lupus erythematosus (SLE).

RUBY-3 (NCT05732402) – Phase 1b Glomerulonephritis Basket Study

RUBY-3 is a is a multi-ascending dose, multi-cohort open label study that will enroll subjects with proteinuric IgA nephropathy, lupus nephritis or primary membranous nephropathy in small disease- and dose-specific cohorts for up to 48 weeks. Endpoints will include changes in disease-specific autoantibodies as well as proteinuria, eGFR and various definitions of renal response

RUBY-4 (NCT05757570)- Phase 1b Autoimmune Cytopenia Basket Study

RUBY-4 is a parallel-arm, multi-cohort open label study that will enroll patients with immune thrombocytopenia, warm autoimmune hemolytic anemia, or cold agglutinin disease in disease-specific cohorts, using a 2-stage Fleming design for up to 48 weeks. Endpoints will include standard definitions of response, such as durable responses. Changes in anti-platelet or anti-red blood cell autoantibodies will also be followed.

Acazicolcept is a first-in-class dual inhibitor of the CD28 and ICOS T cell costimulatory pathways. The molecule is being developed for treatment of severe inflammatory diseases.

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.