NCT06726096

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

Randomized,Double-blind,Placebo,Positive-controlled Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 615 (estimated)
• Sponsor: Beijing VDJBio Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
BIOLOGICAL	Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection	The drug was administered once every 4 weeks. Other Names: Tocilizumab Injection placebo control

Timeline

• Start date: 2025-04-09
• Primary completion: 2026-04-20
• Completion: 2026-12-31
• First posted: 2024-12-10
• Last updated: 2025-08-11

Locations

1 site across 1 country: China