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drugset / Trial / NCT05957107

Phase II Trial of VDJ001 in Patients With Moderate-to-severe Active Rheumatoid Arthritis

NCT05957107 ↗

Phase 2 Completed 181 enrolled Beijing VDJBio Co., LTD.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, randomized, double-blind, placebo and tocilizumab controlled phase II trial in RA patients to evaluate the initial efficacy, safety, pharmacokinetic, pharmacodynamic characteristics, and immunogenicity of VDJ001 in RA patients.

Timeline

Start
2022-05-26
Primary completion
2023-06-02
Completion
2023-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 8 mg/kg —
Subject VDJ001 Monoclonal antibody 4 mg/kg —
Subject VDJ001 Monoclonal antibody 6 mg/kg —

Indications

rheumatoid arthritis