NCT07363460

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lupus Nephritis (LN)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-18
• Primary completion: 2027-11-05
• Completion: 2028-07-06
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: China