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RECRUITING
NCT06819826
PHASE3

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

Sponsor: Biocity Biopharmaceutics Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2025-02-14

Completion Date

2028-12-31

Last Updated

2025-02-17

Healthy Volunteers

No

Interventions

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.

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Yuexiu District, China