Actively Recruiting
A Phase 3 Randomized, Double-Blind Study Comparing QL1074 and Placebo in Achieving Kidney Remission in Active Lupus Nephritis
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2024-05-09
270
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of QL1074 compared with a placebo in achieving kidney improvement in people with active lupus nephritis over a 52-week treatment period. The study focuses on whether adding QL1074 to standard care, which includes mycophenolate mofetil and corticosteroids, can reduce disease activity and proteinuria levels. Participants must have a confirmed diagnosis of lupus nephritis with active kidney involvement based on clinical and biopsy findings. Participants will receive either oral QL1074 at a dose of 23.7 mg twice daily or a matching placebo for 52 weeks. All subjects will continue background therapy with mycophenolate mofetil and an initial intravenous methylprednisolone treatment followed by a tapering course of oral corticosteroids. Dose adjustments for QL1074 may occur based on safety concerns such as blood pressure or kidney function. The study is randomized, double-blind, and placebo-controlled. During the study, participants will undergo regular assessments including urine protein measurements, kidney function tests, and blood tests to monitor disease activity and safety. Researchers will evaluate outcomes such as complete kidney remission at week 52, changes in urine protein levels, and patient-reported outcomes. Safety will be closely monitored throughout the trial. The overall participation duration is about one year, and the study includes ongoing evaluations at multiple time points.
CONDITIONS
Brief Title
A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures.
- Be male or female aged 18 to 75 years at screening.
- Have a previous diagnosis of systemic lupus erythematosus (SLE) based on American College of Rheumatology criteria.
- Have active lupus nephritis confirmed by kidney biopsy within 2 years showing Class III, IV, or V disease.
- Have urine protein creatinine ratio (UPCR) of at least 1.5 mg/mg for Class III/IV or 2 mg/mg for Class V at screening.
- Require high-dose corticosteroids and immunosuppressive therapy as evaluated by the investigator.
- Be willing to take oral mycophenolate mofetil (MMF) during the study.
- Fertile subjects must agree to use reliable contraception from consent until 3 months after the trial ends; women of childbearing potential must have negative pregnancy tests at screening and baseline.
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m2 at screening.
- Currently taking or planning to use prohibited drugs during the trial without required washout.
- Currently needing or expected to require renal dialysis during the study.
- Previous kidney transplant or planned transplant during the study treatment period.
- Known allergy or contraindication to study drugs including MMF, cyclosporine, voclosporin, or corticosteroids.
- History of drug or alcohol abuse within 2 years before screening.
- Malignancy within 5 years except fully treated basal or squamous cell carcinoma.
- Recent severe viral infection or known HIV infection.
- Active or untreated tuberculosis.
- Severe cardiovascular disease or poorly controlled hypertension.
- Liver dysfunction exceeding specified limits unless improved before randomization.
- Chronic lung diseases needing oral steroids.
- Bone marrow insufficiency unrelated to lupus.
- Active bleeding or infections requiring intravenous antibiotics at screening.
- Other immune diseases affecting study outcomes except SLE and lupus nephritis.
- Live vaccines within 4 weeks before screening or during treatment.
- Significant unstable physical or mental illness affecting study progress.
- Pregnant or breastfeeding women.
- Participation in another drug or device trial within 4 weeks before screening or within 5 half-lives of that drug.
- Previous participation in a voclosporin trial with treatment exposure.
- Any conditions judged by investigators to affect trial results or pose excessive risk.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive QL1074 or placebo combined with background therapy for active lupus nephritis to reduce disease activity over 52 weeks.
Multiple visits at baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 52
Trial Site Locations
Total: 10 locations
1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Actively Recruiting
2
The People's Hospital of Bozhou
Bozhou, Anhui, China
Actively Recruiting
3
Anhui Provincial Hospital
Hefei, Anhui, China
Actively Recruiting
4
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
5
Chincse PLA General Hosptial
Beijing, Beijing Municipality, China
Actively Recruiting
6
Peking University First Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
7
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Actively Recruiting
8
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Actively Recruiting
9
Huashan Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
10
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Actively Recruiting
Research Team
F
Feng Guo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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