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

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 11, 2025 (before its estimated April 20, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Apr 15, 2025 to Apr 9, 2025
    • Site contact updated
    v3
  2. Start date: Dec 31, 2024 to Apr 15, 2025
    • Primary completion date: Dec 31, 2025 to Apr 20, 2026
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06726096
Lead Sponsor Beijing VDJBio Co., LTD.
Conditions
(from sponsor)		 Rheumatoid Arthritis (RA), Anti IL-6R
Related terms Arthritis, Rheumatoid
Enrollment 615 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov