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