A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis

Summary

This is a sequential phase 2/3 study to evaluate the efficacy and safety of twice-weekly subcutaneous (SC) infusions of APL2 in patients diagnosed with FSGS. The initial phase 2 portion is a single-arm, open-label study in adults diagnosed with FSGS. Phase 2 will commence prior to randomizing for phase 3. The phase 3 portion of the study is a randomized, placebo-controlled, double-blinded, multicenter study in adults and adolescents diagnosed with FSGS.

Timeline

Start

2026-12

Primary completion

2029-10

Completion

2029-12

Drugs

Indications