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

Rheumatoid Arthritis Clinical Trial

Official title:
Randomized, Double-blind, Placebo, Positive-controlled Phase II Trial of VDJ001 in Patients With Moderate-to-severe Active Rheumatoid Arthritis

Clinical Trial 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.

Clinical Trial Description

After screening, eligible subjects were randomly assigned in a 1:1:1:1 ratio to VDJ001 4 mg/kg group, VDJ001 6 mg/kg group, placebo group, and tocilizumab group to receive trial drug or control drug every 4 weeks. The treatment course was 12 weeks (D1, W4, W8 administration, followed up to W12). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05957107
Study type Interventional
Source Beijing VDJBio Co., LTD.
Contact
Status Completed
Phase Phase 2
Start date May 26, 2022
Completion date June 2, 2023
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