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RECRUITING
NCT07363460
PHASE2

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

Sponsor: Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2025-11-18

Completion Date

2028-07-06

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

DRUG

HSK39297 200mgQD

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

DRUG

HSK39297 300mgQD

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

DRUG

Placebo

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