Trials / Completed
CompletedNCT05247203
Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus
A Phase I, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Telitacicept in Chinese Subjects With Systemic Lupus Erythematosus (SLE)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- RemeGen Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, open-label, phase I study.
Detailed description
The purpose of this study is to evaluate the pharmacokinetics, safety and efficacy of Telitacicept in Chinese patients with systemic lupus erythematosus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-05-11
- Primary completion
- 2023-10-25
- Completion
- 2023-11-13
- First posted
- 2022-02-18
- Last updated
- 2023-12-06
Locations
19 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05247203. Inclusion in this directory is not an endorsement.