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

NCT06406205 | Recruiting Phase 3

• 1 other identifier: QLG1074-301
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Renal Remission at Week 52

  The primary efficacy endpoint was the number of subjects showing complete renal response at Week 52. Complete renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria： UPCR of ≤0.5 g/g \& eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of \>20%

  Week 52

Secondary Outcomes (12)

• Time to Urine Protein Creatinine Ratio of ≤0.5 g/g(Number of Days)

  52 Weeks

• Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 g/g or Less

  52 Weeks

• Number of Subjects With Partial Renal Response at Week 52

  Week 52

• Time to 50% Reduction in UPCR (Number of Days)

  52 Weeks

• Number of Subjects With Partial Renal Response at Week 24

  Week 24

Study Arms (2)

Voclosporin（QL1074）

EXPERIMENTAL

oral, 23.7 mg twice daily (BID)，52 weeks Drug: Voclosporin calcineurin inhibitor Other Names: QL1074

Drug: Voclosporin（QL1074）

Placebo Oral Capsule

PLACEBO COMPARATOR

Voclosporin placebo, oral, 3 capsules twice daily (BID)，52 weeks Drug: Placebo Oral Capsule matching placebo capsule

Drug: Placebo

Interventions

Voclosporin（QL1074） DRUG

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.

Voclosporin（QL1074）

Placebo DRUG

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

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 products.
• 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. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed;
• 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:
• 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 \<2.5 times upper limit of normal before randomization;
• 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);

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (10)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

RECRUITING

The People's Hospital of Bozhou

Bozhou, Anhui, China

RECRUITING

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Chincse PLA General Hosptial

Beijing, Beijing Municipality, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Guangyan Cai, MD

  Chincse PLA General Hosptial

  STUDY CHAIR

Central Study Contacts

Feng Guo

CONTACT

0531-55821177; feng11.guo@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: May 9, 2024
• Study Start: December 25, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)