NCT06819826

A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SC0062 Capsule in Patients with IgA Nephropathy and Proteinuria (SUCCESS-1)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Biocity Biopharmaceutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of SC0062 capsule compared to placebo in patients with IgA nephropathy in the presence of proteinuria. The participants must have a high risk of disease progression, despite of stable use of the maximum tolerated labelled or optimized dose of RAASi and/or SGLT2i for at least 12 weeks prior to randomization.

Conditions

• IgA Nephropathy (IgAN)

Interventions

Type	Name	Description
DRUG	SC0062 strength 10mg	Subjects will take 20 mg once daily for 108 weeks during the treatment period.
DRUG	Placebo matched to SC0062	Subjects will take 20 mg once daily for 108 weeks during the treatment period.

Timeline

• Start date: 2025-02-14
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2025-02-11
• Last updated: 2025-02-17

Locations

1 site across 1 country: China