Efficacy and Safety of Telitacicept in Early SLE

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

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

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).

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