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

NCT07363460 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-01-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • bicheng Liu · Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-18
Primary Completion
2027-11-05
Completion
2028-07-06

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07363460 on ClinicalTrials.gov