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RECRUITING
NCT06406205
PHASE3

A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy of QL1074 compared with placebo in achieving renal response after 52 weeks of therapy in subjects with Active Lupus Nephritis.

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of QLG1074 With Placebo in Achieving Renal Remission in Subjects With Active Lupus Nephritis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

270

Start Date

2023-12-25

Completion Date

2028-06

Last Updated

2024-05-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

Voclosporin(QL1074)

QL1074 23.7 mg BlD will be administered as a fixed dose without the use of therapeutic drugmonitoring. The protocol contains provisions for management of dose based on safety concerns, in particular, BP and renal function,can be managed by dose reduction and temporary of QL1074 to interruption.

DRUG

Placebo

Placebo softgel capsules, identical to 7.9 mg QL1074, will be provided. The administration plan and dosage management regulations are the same as QL1074.

Locations (10)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

The People's Hospital of Bozhou

Bozhou, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Chincse PLA General Hosptial

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Huashan Hospital

Shanghai, Shanghai Municipality, China

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China