drugset / Trial / NCT05212051
Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active AS
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate preliminary efficacy, safety pharmacokinetic (PK) characteristics, pharmacodynamics (PD) haracteristics and immunogenicity of JS005 at different doses in Chinese patients with active Ankylosing Spondylitis. Treatment difference of JS005 150mg,300mg,450mg vs. placebo in Chinese AS patients in terms of ASAS 20 response rate at Week 16 as well as safety profile will be provided by the study .
Timeline
- Start
- 2021-12-10
- Primary completion
- 2022-11-02
- Completion
- 2023-01-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ROCONKIBART | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | ROCONKIBART | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | ROCONKIBART | Monoclonal antibody | 450 mg | Subcutaneous |