Clinical Trial

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

Suspended Phase 2/3
View on ClinicalTrials.gov →
Why the trial stopped
Study temporarily suspended due to company acquisition and ongoing strategic evaluation, with recruitment challenges including screening failures
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-10-02.
Status change: Not Yet Recruiting → Suspended 2026-06-17
Trial Details
NCT Number NCT07213960
Lead Sponsor Apellis Pharmaceuticals, Inc.
Conditions FSGS
Enrollment 270 participants
Start Date 2026-12
Primary Completion 2029-10 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-22