drugset
drugset / Trial / NCT05242588

Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active Nr-axSpA

NCT05242588 ↗

Phase 2 Unknown 120 enrolled Shanghai Junshi Bioscience Co., Ltd. Sponsor GmbH · collab
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 non-radiographic axial spondyloarthritis(nr-axSpA). Treatment difference of JS005 150mg,300mg,450mg vs. placebo in Chinese nr-axSpA patients in terms of ASAS 40 response rate at Week 16 as well as safety profile will be provided by the study .

Timeline

Start
2022-01-26
Primary completion
2023-04-01
Completion
2023-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject ROCONKIBART Monoclonal antibody 150 mg Subcutaneous
Subject ROCONKIBART Monoclonal antibody 300 mg Subcutaneous
Subject ROCONKIBART Monoclonal antibody 450 mg Subcutaneous

Indications

spondyloarthropathy