Efficacy and Safety of Telitacicept in Early SLE

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: RemeGen Co., Ltd.

Criteria

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