Efficacy and Safety of Telitacicept in Early SLE

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with early stage of SLE .

Detailed Description
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This is a phase 4, multicentre, randomised, double-blind, open-labeled study to evaluate the efficacy and safety of telitacicept in adult subjects with active early stage of SLE (disease duration less than 2 years).

Official Title
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A Study of Telitacicept in the Treatment of Early Stage Systemic Lupus Erythematosus

Conditions
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Lupus Erythematosus, Systemic

Intervention / Treatment
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* Drug: Telitacicept
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria 18-65 years of age body weight 45-90kg antinuclear antibody titers ≥1:80, and/ or anti-double-stranded DNA antibodies SLEDAI-2K score ≥8 scores Disease duration less than 2 years (defined as the duration between the first appearance of any symptom/sign attributed to SLE and baseline) A stantard therapy for at least 30d for patients who are not treatment-naive Negative pregnancy test for child-bearing women at screening and baseline Provide written informed consent Exclusion Criteria: Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, and Immunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al Active serious neuropsychiatric systemic lupus erythematosus or other severe situations of SLE who need pulse steroid treatment severe lupus nephritis: 24hUP more than 6g, serum creatinine > 221umol/L History of severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) requiring intervention within 60 days of baseline (Day 1) Abnormal liver function (ALT or AST is 2 times higher than normal) Baseline IgG below the lower limit of the normal range Pregnancy or breastfeeding women Have a history of malignant tumors Have any serious acute, chronic or recurrent infectious disease (such as pneumonia or active stage of pyelitis, recurrent pneumonia, chronic bronchiectasis and tuberculosis) Chronic infections, such as Hepatitis B virus or hepatitis B and C and HIV Cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolic pressure > 160mmHg or diastolic pressure > 100mmHg) or diabetics Active hemorrhage or peptic ulcer With other concommitant autoimmune disease; Receipt of B-cell-targeted therapy (including belimumab) within 1 year before randomization Receipt of IVIG within 28 days before randomization Receipt of TNF inhibitor, IL-1R inhibitor or plasma exchange therapy within 90 days before randomization Participated in other drugs clinical trials within 4 weeks. Receipt of live vaccine within 4 weeks before randomization Receipt of COVID-19 vaccine within 4 weeks before randomization Subjects who in the opinion of the investigator are not suitable to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Standard of care plus Telitacicept 160 mg sc per week; after week 12, the dose can be reduced to 80 mg per week due to safety considerations. | Drug: Telitacicept<br>* 160mg once a week for 48 weeks<br>* Other names: RC18;Drug: Standard of Care<br>* Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.<br>|
| Other: Control group<br>Standard of care | Drug: Standard of Care<br>* Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of LLDAS in week 24 | Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of LLDAS in week 12 | Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials | week 12 | 
| Improvement in SLEDAI-2K | Proportion of patients with SLEDAI-2K scores improvement ≥4 compared with baseline | week 24 and 52 | 
| Improvement in serological indices | Improvement in anti-dsDNA antibody titers, C3, C4, T cell and B cell subsets and IgG, IgA, IgM compared with baseline | week 24, 52 | 
| Change in PGA | PGA: physician global assesment(0-3) | week 24, 52 | 
| Number of participants with Adverse Events | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose resulting in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant and which the investigator regards as serious based on appropriate medical judgment. | up to week 52 | 
| Disease flare | Proportion of patients suffer from SLE flare | up to week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus Erythematosus, Systemic, Telitacicept