RecruitingPhase 2NCT07363460

Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HSK39297 Tablets in Patients With Lupus Nephritis


Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Enrollment

105 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HSK39297 200mgQD, a drug called HSK39297 300mgQD, and others for people with lupus nephritis (ln). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHSK39297 200mgQD

once daily, oral administration of HSK39297 tablets 200mg from Day 1 to Week 52.

DRUGHSK39297 300mgQD

once daily, oral administration of HSK39297 tablets 300mg from Day 1 to Week 52.

DRUGPlacebo

once daily, oral administration of placebo from Day 1 to Week 52.


Locations(1)

Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine

Nanjing, Jiangsu, China

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NCT07363460


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