The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment

NCT07340463 | Recruiting Phase 2

• 1 other identifier: 2024LCYXXH009
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study Design This is a single-center, prospective, randomized, controlled, exploratory clinical trial. The study is designed to evaluate and compare the efficacy and safety of two biologic-based induction regimens against standard of care (SOC) and a triple-combination regimen in patients with active proliferative lupus nephritis (LN).
2. 2.Study Objectives Primary Objective: To compare the 6-month complete renal response (CRR) rate among patients receiving biologic-based induction therapy, SOC induction therapy, and triple-combination induction therapy.
3. 3.Key Eligibility Criteria Patients aged 14-65 years with biopsy-proven active Class III or IV (±V) LN according to ISN/RPS 2018 classification, an SLE-DAI score \>6, and 24-hour urine protein \>1.0 g/d will be eligible. Key exclusion criteria include an eGFR ≥45 ml/min/1.73m², recent use of renal replacement therapy or potent immunosuppressive procedures, significant concurrent infections, severe hematological/ hepatic abnormalities, and known hypersensitivity to the study biologics.
4. 4.Treatment Groups and Intervention
5. 5.Study Medications \& Administration Glucocorticoids: All patients will receive oral prednisone (or equivalent) starting at 0.5 mg/kg/day (max 40 mg/day), with a mandatory taper to ≤5 mg/day by Month 4 and stable dosing from Months 5-6. Intravenous methylprednisolone pulses are permitted per investigator discretion.
6. 6.Primary Efficacy Endpoint

Conditions

Systemic Lupus Erythematosus (SLE); Lupus Nephritis (LN)

Keywords

SLE; LN; Belimumab; Lupus Nephritis; Telitacicept

Outcome Measures

Primary Outcomes (1)

• Complete Renal Response (CRR) Rate at Month 6

  Proportion of patients achieving Complete Renal Response. CRR is defined as: 24-hour urine protein \< 0.5 g/d, AND estimated glomerular filtration rate (eGFR) ≥ 85% of the baseline value, AND no receipt of rescue therapy or premature withdrawal from treatment.

  From Baseline to Month 6

Secondary Outcomes (7)

• Partial Renal Response (PRR) Rate at Months 1, 2, 3, 4, 5, and 6

  From Baseline to Months 1, 2, 3, 4, 5, and 6

• Overall Renal Response (ORR) Rate at Months 1, 2, 3, 4, 5, and 6

  From Baseline to Months 1, 2, 3, 4, 5, and 6

• Time to Achieve Complete or Partial Renal Response

  From randomization up to Month 6

• Proportion of Patients with Renal-Related Events by Month 6

  From Baseline to Month 6

• Change from Baseline in 24-hour Urine Protein Quantification

  Baseline, Months 1, 2, 3, 4, 5, and 6

Study Arms (3)

Biologics Group

EXPERIMENTAL

Glucocorticoids combined with a biologic agent (Belimumab or Telitacicept). All subjects receive oral glucocorticoids (starting dose 0.5 mg/kg/day, ≤40 mg/day, planned taper to ≤5 mg/day by Month 4). Combined with one biologic agent: Belimumab (IV infusion, 10 mg/kg/dose, every 2 weeks) or Telitacicept (subcutaneous injection, 160 mg/dose, once weekly). The specific biologic is chosen through discussion between the investigator and the patient. If no response after 3 months of induction therapy, subjects may switch to the Triple Therapy Group.

Drug: Glucocorticoids; Biological: belimumab; Biological: Telitacicept

Standard of Care (SOC) Group

ACTIVE COMPARATOR

Glucocorticoids combined with Mycophenolate Mofetil (Standard of Care regimen). All subjects receive the same oral glucocorticoid regimen as the Biologics Group. Combined with Mycophenolate Mofetil (MMF), target dose 1.5-2.0 g/day, administered orally in two divided doses. If no response after 3 months of induction therapy, subjects may switch to the Triple Therapy Group.

Drug: Glucocorticoids; Drug: Mycophenolate mofetil (MMF)

Triple Therapy Group

EXPERIMENTAL

Glucocorticoids combined with Mycophenolate Mofetil and a biologic agent (Belimumab or Telitacicept). All subjects receive the same oral glucocorticoid regimen as the other groups. Combined with Mycophenolate Mofetil (MMF) (target dose 1.5-2.0 g/day) and one biologic agent (Belimumab, every 2 weeks; or Telitacicept, once weekly). The specific biologic is chosen through discussion between the investigator and the patient. This group is both one of the initially randomized arms and the rescue therapy arm for non-responders from the other two groups.

Drug: Glucocorticoids; Biological: belimumab; Biological: Telitacicept; Drug: Mycophenolate mofetil (MMF)

Interventions

Glucocorticoids DRUG

Background therapy for all study arms. All subjects receive glucocorticoid therapy. The oral starting dose is prednisone 0.5 mg/kg/day (or equivalent), not exceeding 40 mg/day. Planned taper to ≤5 mg/day by Month 4, with stable dosing from Months 5-6. The tapering speed is determined by investigator assessment during the study. Permitted at investigator's discretion: intravenous methylprednisolone pulse therapy (dose 0.25-3.0g).

Also known as: Corticosteroids

Biologics Group; Standard of Care (SOC) Group; Triple Therapy Group

belimumab BIOLOGICAL

A humanized monoclonal antibody targeting B-cell activating factor (BAFF). Used in the "Biologics Group" and the "Triple Therapy Group". Administered via intravenous infusion every 2 weeks at a dose of 10 mg/kg (600mg/dose) for 6 months. Premedication with dexamethasone and antihistamines is required for the first infusion to prevent allergic reactions (dexamethasone may be omitted for subsequent infusions if no prior reaction).

Also known as: Benlysta

Biologics Group; Triple Therapy Group

Telitacicept BIOLOGICAL

A TACI-Fc fusion protein that neutralizes both BAFF and APRIL cytokines. Used in the "Biologics Group" and the "Triple Therapy Group". Administered via subcutaneous injection once weekly at a dose of 160mg for 6 months.

Biologics Group; Triple Therapy Group

Mycophenolate mofetil (MMF) DRUG

An immunosuppressive agent. Used in the "Standard of Care (SOC) Group" and the "Triple Therapy Group". Administered orally in two divided daily doses, target dose 1.5-2.0 g/day. Maintained at the target dose until the end of the treatment period. Dose adjustment or brief interruption (preferably not exceeding 14 days) is permitted in case of specific hematologic toxicity or infectious complications.

Standard of Care (SOC) Group; Triple Therapy Group

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent form. 2.Age 14-65 years (inclusive), any gender. 3.Meets the American College of Rheumatology (ACR) SLE diagnostic criteria (1997).
• All patients have biopsy-confirmed class III/IV ± V LN within the past six months.
• SLE-DAI score \> 6. 6.Urine protein quantification \> 1.0 g/d.

You may not qualify if:

• Estimated glomerular filtration rate (eGFR) ≥45 ml/min/1.73 m². 2.Patients who have received renal replacement therapy, plasma exchange, immunoadsorption, or high-dose intravenous immunoglobulin (100g) within the past 2 months.
• Patients with concomitant critical organ damage or lupus crisis (e.g., pulmonary hemorrhage, encephalopathy, heart failure) deemed unsuitable for clinical trial participation by the investigator.
• Hematological abnormalities: White blood cells \<3000/μL, absolute neutrophil count \<1500/μL, or lymphocytes \<800/μL, platelet count \<50,000/μL (unless due to SLE activity).
• Liver function abnormalities: ALT, AST, or bilirubin levels exceeding 2 times the upper limit of normal.
• Known allergy or contraindication to any component of belimumab and/or telitacicept.
• Active infection or intravenous antibiotic use within 1 month prior to enrollment.
• Pregnant or breastfeeding women. 9.Current or within the past 3 months: Active hepatitis B, hepatitis C, tuberculosis, cytomegalovirus pneumonia, active fungal infection, syphilis infection, or HIV infection; active peptic ulcer; history of drug abuse or alcoholism; severe malnutrition (BMI \<16 kg/m²).
• Other conditions: Severe cardiovascular disease potentially life-threatening; chronic obstructive pulmonary disease, or asthma/allergic diseases requiring long-term oral steroid treatment; malignant hypertension; history of malignancy within the past 5 years (except for completely treated basal cell or squamous cell skin cancer or cervical intraepithelial neoplasia).
• Other situations deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• Nanjing University School of Medicine: lead

Study Sites (1)

Clinical Research Ethics Committee of the General Hospital of Eastern Theater Command of the People's Liberation Army

Nanjing, Jiangsu, 210016, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Interventions

Glucocorticoids; Adrenal Cortex Hormones; belimumab; telitacicept; Mycophenolic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Central Study Contacts

Zhi-Hong Liu, MD

CONTACT

86+025-80860218; njrin@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 14, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD and supporting information will become available for sharing after the primary results of this study are officially published (expected no later than June 2028). The data will be accessible for at least 5 years thereafter (i.e., until June 2033) to provide the research community with sufficient time for secondary analyses and validation. The access period may be extended according to the policies of the data hosting platform or the terms of the Data Use Agreement. The specific start date will be updated in this plan and on the clinical trial registration platform concurrently with the publication of the primary paper.
• Access Criteria: Access is open to researchers from academic or non-profit institutions for legitimate academic purposes. For-profit entities may apply for non-commercial use, subject to data protection regulations. Approved researchers will access the de-identified IPD dataset (see Plan Description) and supporting documents (Study Protocol, SAP, ICF). Access is read-only; downloading or redistributing raw data is prohibited. Access is controlled via formal application, including: a detailed research proposal (scientific value, objectives, methods), ethical approval or waiver, and a signed Data Use Agreement (DUA). The DUA prohibits re-identification, restricts use to approved analyses, and requires proper citation of the original study. Applications are reviewed by the Principal Investigator or institutional Data Access Committee. Approved users will access data through a secure, encrypted platform.

Locations

CN (1)