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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Written informed consent before any study-specific procedures are performed.

• Male or female subjects with a minimum age of 18 (or legal age of consent if \>18 years) to 75 years of age, inclusive, at the time of screening (Visit 1).

• Previous diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997)

• Subjects with evidence of active nephritis, According to the 2018 International Society of Nephrology/Society of Nephropathology (ISN/RPS) classification criteria for lupus nephritis, defined as follows:

‣ Kidney biopsy result within 2 years prior to screening indicating Class III, IV (alone or in combination with Class V), or Class V LN, Biopsy results must be reviewed with the Investigator to confirm eligibility.

⁃ UPCR of a minimum of ≥1.5 mg/mg for Class III/IV or to a minimum of ≥2 mg/mg for Class V at screening.

⁃ If the subject provides a biopsy report within 2 years but more than 6 months before screening, the UPCR needs to be doubled at least within 6 months before screening.

• According to the Investigators' evaluation, subject requires high-dose corticosteroids and immunosuppressive therapy.

• Subject is willing to take oral MMF for the duration of the study, either by continuing current MMF therapy or by initiating it on or before the Baseline Visit.

• Fertile subjects (both male and female) must agree to use reliable contraception methods with their partners from the time of signing the informed consent form until 3 months after the end of the trial; women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.

Locations
Other Locations
China
Chincse PLA General Hosptial
RECRUITING
Beijing
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical University
RECRUITING
Bengbu
The People's Hospital of Bozhou
RECRUITING
Bozhou
Heping Hospital Affiliated to Changzhi Medical College
RECRUITING
Changzhi
The First Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Anhui Provincial Hospital
RECRUITING
Hefei
The Second Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Huashan Hospital
RECRUITING
Shanghai
Contact Information
Primary
Feng Guo
feng11.guo@qilu-pharma.com
0531-55821177
Time Frame
Start Date: 2023-12-25
Estimated Completion Date: 2028-06
Participants
Target number of participants: 270
Treatments
Experimental: Voclosporin(QL1074)
oral, 23.7 mg twice daily (BID),52 weeks Drug: Voclosporin calcineurin inhibitor Other Names: QL1074
Placebo_comparator: Placebo Oral Capsule
Voclosporin placebo, oral, 3 capsules twice daily (BID),52 weeks Drug: Placebo Oral Capsule matching placebo capsule
Sponsors
Leads: Qilu Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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