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

NCT05957107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2025-07-09

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection

The drug was administered once every 4 weeks.

Sponsors & Collaborators

  • Beijing VDJBio Co., LTD.

    lead INDUSTRY

Principal Investigators

  • Zhan-guo Li · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05957107 on ClinicalTrials.gov