Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus
NCT05247203 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92
Last updated 2023-12-06
Summary
This is a multi-center, open-label, phase I study.
Conditions
Interventions
- BIOLOGICAL
-
Telitacicept
subcutaneous injection
- DRUG
-
standard therapy
A standard regimen consists of the following medication(s) (alone or in combination):corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.
Sponsors & Collaborators
-
RemeGen Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-11
- Primary Completion
- 2023-10-25
- Completion
- 2023-11-13
Countries
- China
Study Locations
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