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

PHASE3RecruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

December 25, 2023

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2028

Conditions
Lupus Nephritis
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.

Trial Locations (10)

Unknown

RECRUITING

The First Affiliated Hospital of Bengbu Medical University, Bengbu

RECRUITING

The People's Hospital of Bozhou, Bozhou

RECRUITING

Anhui Provincial Hospital, Hefei

RECRUITING

The Second Affiliated Hospital of Anhui Medical University, Hefei

RECRUITING

Chincse PLA General Hosptial, Beijing

NOT_YET_RECRUITING

Peking University First Hospital, Beijing

RECRUITING

Fujian Medical University Union Hospital, Fuzhou

RECRUITING

The First Affiliated Hospital of Dalian Medical University, Dalian

RECRUITING

Huashan Hospital, Shanghai

RECRUITING

Heping Hospital Affiliated to Changzhi Medical College, Changzhi

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY