Efficacy and Safety of Telitacicept in Early SLE

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 4

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: Standard of Care; Drug: Telitacicept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05899907

PUMCH-HS3345D

Details and patient eligibility

About

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

Full 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).

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Treatment group

Experimental group

Description:

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.

Treatment:

Drug: Telitacicept

Drug: Standard of Care

Control group

Other group

Description:

Standard of care

Treatment:

Drug: Standard of Care