drugset / Trial / NCT05247203

Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus

NCT05247203

Phase 1 Completed 92 enrolled RemeGen Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multi-center, open-label, phase I study.

Timeline

Start
2022-05-11
Primary completion
2023-10-25
Completion
2023-11-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Telitacicept Protein / enzyme biologic 80 mg Subcutaneous
Subject Telitacicept Protein / enzyme biologic 160 mg Subcutaneous
Subject Telitacicept Protein / enzyme biologic 240 mg Subcutaneous
Background Azathioprine Small molecule
Background Cyclophosphamide Other / unclassified
Background Cyclosporine Peptide
Background Leflunomide Small molecule
Background Methotrexate Small molecule
Background Mycophenolate Mofetil Small molecule
Background Tacrolimus Small molecule