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Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis

NCT06726096 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 615

Last updated 2025-08-11

No results posted yet for this study

Summary

A multicenter, randomized, double-blind, placebo-controlled, and active drug-controlled Phase III pivotal clinical trial of recombinant humanized anti-interleukin-6 receptor monoclonal antibody injection (VDJ001) for the treatment of moderate-to-severe active rheumatoid arthritis with poor response to methotrexate

Conditions

  • Rheumatoid Arthritis (RA)
  • Anti IL-6R

Interventions

BIOLOGICAL

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection

The drug was administered once every 4 weeks. Other Names: Tocilizumab Injection placebo control

Sponsors & Collaborators

  • Beijing VDJBio Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-04-09
Primary Completion
2026-04-20
Completion
2026-12-31

Countries

  • China

Study Locations

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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 NCT06726096 on ClinicalTrials.gov