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New treatment option for Lupus Nephritis
Official title A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis
ClinicalTrials.gov ID: NCT06406205
What this study is testing
What is Voclosporin（QL1074）?
Voclosporin（QL1074） is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus nephritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Written informed consent before any study-specific procedures are performed.
- Male or female people 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...
- Previous diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997)
- people with evidence of active nephritis, According to the 2018 International Society of Nephrology/Society of Nephropathology (ISN/RPS)...
- 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...
You likely can't join if
- Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/minute/1.73 m2...
- urrently taking or planning to use drugs or treatments listed in the Prohibited Drugs (Section 5.5) during the trial, including not completing the...
- Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- A previous kidney transplant or planned transplant within study treatment period.
- Any known hypersensitivity or contraindication to any of the drugs planned to be used (including but not limited to: MMF, Mycophenolate Sodium...
- Current or medical history of:
See the full eligibility criteria
Who can join
- Written informed consent before any study-specific procedures are performed.
- Male or female people 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)
- people 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 people (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...
What rules you out
- Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/minute/1.73 m2 at screening.
- urrently taking or planning to use drugs or treatments listed in the Prohibited Drugs (Section 5.5) during the trial, including not completing the required washout.
- Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- A previous kidney transplant or planned transplant within study treatment period.
- Any known hypersensitivity or contraindication to any of the drugs planned to be used (including but not limited to: MMF, Mycophenolate Sodium, Cyclosporine, Voclosporin, Corticosteroids) or any components of these drug...
- Current or medical history of:
- The subject has a history of drug abuse or alcohol abuse within 2 years before the screening period;
- Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. people with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been...
- Lymphoproliferative disease or previous total lymphoid irradiation;
- Severe viral infection (e.g., cytomegalovirus, hepatitis B virus, hepatitis C virus) within 3 months of screening; or known HIV infection. Severe viral infection is defined as active disease requiring antiviral therapy;
- Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid;
- Other known clinically significant active medical conditions, such as:
- Severe cardiovascular disease including congestive heart failure, history of cardiac dysrhythmia, congenital long QT syndrome or Hypertension with poor control (systolic blood pressure ≥165mmHg and/or diastolic blood...
- Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or bilirubin ≥2.5 times the upper limit of normal) at screening and, if abnormal at screening, then confirmed that the levels have returned to...
- Chronic obstructive pulmonary disease or asthma requiring oral steroids;
- Bone marrow insufficiency unrelated to active SLE (according to Investigator judgment) with white blood cell count \<2.5×109/L; absolute neutrophil count \<1.3×109/L; thrombocytopenia (platelet count \<50×109/L);
- According to the evaluation of the investigator, the subject suffered from active bleeding;
- Patients with infections requiring intravenous antibiotic treatment (antibacterial drugs, antiviral drugs, antifungal drugs, or antiparasitic drugs) during screening;
- According to the researchers' assessment, the people have other congenital or acquired immune diseases (except for SLE and LN), for which the condition or the treatment of the condition may affect the study assessments...
- No vaccines using live vaccines or attenuated live vaccines are allowed in the 4 weeks before the screening and while taking the study treatment.
- According to the evaluation of the investigators, there have been significant, unstable or poorly controlled physical/mental illnesses or traumas that may affect the progress or results of the trial within the first 6...
- Women who are pregnant or breastfeeding.
- Participated in another drug or device trial within 4 weeks before the screening period or within 5 half-lives of the drug (whichever is longer).
- The subject has participated in previous clinical trials of Voclosporin, was randomly assigned to a group, and received treatment with the trial drug.
- According to the assessment of the investigators, there may be conditions that affect the results of the trial or that the risks to the people outweigh the benefits.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Bozhou, Anhui, China
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Dalian, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Changzhi, Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Bozhou, Anhui, China; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Dalian, Liaoning, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.