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

PUMCH-HS3345D

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

2022-09-01

2025-03-01

2025-09-01

Recruiting

Early phase I

180

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}

2023-06-12