NCT07213960

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

A Sequential Phase 2/3, Single-Arm, Open-Label Study in Adults Followed by a Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of APL2 in Adults and Adolescents With Focal Segmental Glomerulosclerosis

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Apellis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• FSGS

Interventions

Type	Name	Description
DRUG	APL2	Complement (C3) Inhibitor
OTHER	Placebo	Sterile solution of equal volume to active arm

Timeline

• Start date: 2025-12-01
• Primary completion: 2029-10-01
• Completion: 2029-12-01
• First posted: 2025-10-09
• Last updated: 2025-10-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study